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C.I. Pigment Brown 24 CAS N°: 68186-90-3

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OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

FOREWORD<br />

INTRODUCITION<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong><br />

<strong>CAS</strong> N°: <strong>68186</strong>-<strong>90</strong>-3<br />

UNEP PUBLICATIONS 1


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

SIDS Initial Assessment Report<br />

For<br />

SIAM 15<br />

Boston, Massachussetts, 22-25 October 2002<br />

1. Chemical Name: C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong><br />

2. <strong>CAS</strong> Number: <strong>68186</strong>-<strong>90</strong>-3<br />

3. Sponsor Country: Japan<br />

Mr. Motohiko Kato, Ministry of Foreign Affairs, Japan<br />

4. Shared Partnership with: BASF AG<br />

5. Roles/Responsibilities of<br />

the Partners:<br />

<br />

<br />

Name of industry sponsor<br />

/consortium<br />

Process used<br />

6. Sponsorship History<br />

<br />

How was the chemical or<br />

category brought into the<br />

OECD HPV Chemicals<br />

Programme ?<br />

7. Review Process Prior to<br />

the SIAM:<br />

8. Quality check process:<br />

9. Date of Submission:<br />

10. Date of last Update:<br />

11. Comments:<br />

Dr. Hubert, Lendle BASF AG<br />

E-mail : hubert.lendle@basf-ag.de<br />

This substance is sponsored by Japan under the ICCA Initiative<br />

and is submitted for first discussion at SIAM 15.<br />

The industry collected new data and prepared the updated<br />

IUCLID, and draft versions of the SIAR and SIAP. Japanese<br />

government peer-reviewed the documents, audited selected<br />

studies.<br />

No testing (X)<br />

Testing ( )<br />

2<br />

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OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

SIDS INITIAL ASSESSMENT PROFILE<br />

<strong>CAS</strong> No. <strong>68186</strong>-<strong>90</strong>-3<br />

Chemical Name C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong><br />

Structural Formula<br />

Complex inorganic coloured pigment based on titanium oxide; in the<br />

rutile lattice, titanium ions are partially replaced by chromium (III) and<br />

antimony (V) ions.<br />

(Ti, Cr, Sb) O 2<br />

SUMMARY CONCLUSIONS OF THE SIAR<br />

Category/Analogue Rationale<br />

In some circumstances, available data for C.I. <strong>Pigment</strong> Yellow 53 (<strong>CAS</strong> No. 8007-18-9, a nickel antimony doped<br />

rutile) may be presented to assist the weight of evidence approach for C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong>, since it is closely<br />

related structurally and similar regarding its non-bioavailabilty. Its toxicological profile was also essentially similar<br />

to C.I. <strong>Pigment</strong> Yellow 53, therefore, analogy considerations can be made where the non-bioavailability is the<br />

determining parameter of non-toxicity. This was the case for reproductive and developmental toxicity.<br />

Human Health<br />

The acute toxicity of C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> after oral exposure is negligible: oral LD50 in rats > 10000 mg/kg body<br />

weight.<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> is minimally irritating to the rabbit skin and may cause slight particle mediated irritating<br />

effects after instillation into the rabbit eye. Coloration of the skin occurred within the first 3 days after application.<br />

No data are available on sensitisation; the substance contains chromium, but no evidence for its bioavailablity was<br />

seen in a repeat oral study in the rat (see below).<br />

No signs of clinical toxicity or histopathological changes were seen in a <strong>90</strong>-day dietary study in the rat. A NOAEL<br />

of 500 mg/kg was identified from this study. In this study there was no evidence for chromium accumulation in the<br />

liver or kidney of rats, and traces of antimony (below 30 µg/kg tissue) were found only in the high dose group.<br />

These traces of antimony may be available from the acid-soluble impurities of the pigment. The small amount of<br />

antimony is considered to have no toxicological significance.<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> induced no gene mutation in bacteria nor in mammalian cells and no clastogenic or<br />

aneugenic effects in mammalian cells with or without addition of a metabolic activation system. Therefore, the in<br />

vitro data indicates that C.I <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> would not exhibit a genotoxic potential in vivo.<br />

There are no specific studies on carcinogenicity available.<br />

No effects on gonads were observed in the <strong>90</strong> day feeding study on rats at doses of up to 500 mg/kg b.w./day (see<br />

above). A developmental toxicity study is not considered necessary because the substance showed no bioavailability<br />

with toxicological relevance after oral exposure (see above). In analogy to C.I. <strong>Pigment</strong> Yellow 53 where no<br />

reproductive or developmental effects were seen in a screening test conducted in rats tested up to 1000 mg/kg bw<br />

according to OECD Guideline 422, no effects are expected with C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong>.<br />

Environment<br />

C.I. <strong>Pigment</strong> brown <strong>24</strong> is a solid, complex inorganic coloured pigment, based on titanium dioxide with chromium<br />

(III) and antimony (V) ions partially replacing titanium ions in the rutile lattice. It is practically inert and has a<br />

melting point above 1000°C. The vapour pressure is estimated to be negligible. C.I. <strong>Pigment</strong> brown <strong>24</strong> has an<br />

extremely low solubility in water; the concentration of chromium and antimony in filtrates (10 g/l) has been<br />

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OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

measured by atomic absorption to be 10,000 mg/l; Daphnia magna: EC 50 (48 h) > 100 mg/l; Desmodesmus subspicatus:<br />

EC 50 (72 h)> 100 mg/l; Pseudomonas putida: EC 50 (30 min) > 10,000 mg/l.<br />

The substance is not acutely toxic to aquatic organisms (fish, invertebrates and algae) in tests with either aqueous<br />

eluates or suspensions prepared with nominal concentrations far exceeding its water solubility.<br />

No data are available on terrestrial organisms.<br />

The substance is inorganic and thus not biologically degradable. According to the low water solubility and the<br />

structural properties of the pigment, bioaccumulation is not expected.<br />

Exposure<br />

<strong>Pigment</strong> brown is used for coloring plastics, ceramics, building materials and coatings. The estimated world<br />

production amounts to 10,000 – 15,000 tonnes.<br />

No data are available concerning exposure. <strong>Pigment</strong>s released from production sites and not having been eliminated<br />

mechanically, will probably absorb to sewage sludge. In the end products, the pigments are fixed in the matrix and a<br />

release into the environment during use phase is not expected.<br />

RECOMMENDATION<br />

The chemical is currently of low priority for further work.<br />

RATIONALE FOR THE RECOMMENDATION AND<br />

NATURE OF FURTHER WORK RECOMMENDED<br />

The chemical is currently of low priority for further work based on a low hazard potential.<br />

4<br />

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OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

SIDS Initial Assessment Report<br />

1 IDENTITY<br />

1.1 Identification of the Substance<br />

<strong>CAS</strong> Number: <strong>68186</strong>-<strong>90</strong>-3<br />

Chemical Name: C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong><br />

Empirical Formula: (Ti, Cr, Sb) O 2<br />

Structure<br />

Complex inorganic coloured pigment based on titanium dioxide; in the<br />

rutile lattice titanium ions are partially replaced by 2 to 6 % chromium<br />

(III) and 8.5 to 14 % antimony (V) ions<br />

According to the intended use, medium particle size varies between 0.5<br />

and 1.5 m.<br />

Synonyms:<br />

Chrome Antimony Titanate<br />

Chrome antimony titaniumoxide rutil<br />

Chrome rutile yellow<br />

C. I. 77310<br />

Titanium, Antimony, Chromium III oxide rutile<br />

1.2 Purity/Impurities/Additives<br />

Substance type: inorganic<br />

Physical status: solid<br />

Purity: > 99% w/w (acid-soluble impurities amount to 10 –20 mg/kg antimony and 10-20 mg/kg<br />

chromium(III). These impurities are not fixed in the lattice and are extractable with HCl. After 2<br />

extractions with HCl, the acid soluble impurities are reduced to amounts below the detection limit<br />

(


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

artists”). The SPIN database lists for the year 2001 for Norway 111 products (754 tons), for<br />

Denmark 128 products (372 tons), for Finland 5 products (0 tons). For Sweden 191 products are<br />

given for the year 2000 (354 tons). The preparations listed for Norway and Sweden include<br />

products for consumer use, In Denmark and Finland, none of the products is for consumer use.<br />

2.1 Environmental Exposure and Fate<br />

Environmental Exposure<br />

Doped rutile pigments are manufactured by reacting finely divided metal oxides, hydroxides or<br />

carbonates in the solid state at a temperature of 1000 to 1,200 °C. The production is based on<br />

reactive anatase, or titanium dioxide hydrolysate containing sulfuric acid, and on the oxidation of<br />

trivalent antimony with oxygen in the form of nitric acid or air. For the production of C.I. <strong>Pigment</strong><br />

<strong>Brown</strong> <strong>24</strong> trivalent chromium raw materials are used.<br />

Raw-material dust, and gases (e.g. SO3 and NOx), emitted during the calcination step are removed<br />

from the flue gas by dust separators and alkaline flue scrubbers. The raw-material dust can be<br />

recycled. Soluble metal salts can be removed by neutral precipitation in the waste-water treatment<br />

plant, and suspended pigment particles can be mechanically separated from the water from washing<br />

and purification steps. Altogether, only a small amount of waste is produced with each tonne of<br />

product (Endriß H., 1998).<br />

In the end products, the pigments are fixed in the matrix and a release into the environment during<br />

the use phase is not expected (coatings) or impossible (colored plastics and ceramics). <strong>Pigment</strong>s<br />

released from production sites and not having been eliminated mechanically will probably absorb to<br />

sewage sludge.<br />

Environmental Fate<br />

Distribution modelling is not applicable since several physical parameters are not available.<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> is an inorganic substance, biodegradation therefore is not assumed.<br />

No data on bioaccumulation are available. However, regarding the extremely low water solubility,<br />

experiences from rodent investigations and the structure-related inert properties of the rutil,<br />

bioavailability and therefore bioconcentration is not expected.<br />

(See also data on bioavailability in mammals after oral exposure [section 3.2.5 and 3.2.9])<br />

2.2 Human Exposure<br />

No data are available concerning exposure with the practically inert pigment.<br />

3 HUMAN HEALTH HAZARDS<br />

3.1 Hazard Assessment Experience with Human Exposure<br />

3.1.1 Experience with human exposure<br />

No data available.<br />

6<br />

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OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

3.2 Effects on Human Health<br />

In analogy to C.I. <strong>Pigment</strong> Yellow 53 (a nickel antimony titanium dioxide rutile with similar low<br />

bioavailability as C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong>), which resulted in no reproductive or developmental<br />

effects in a screening test according to OECD guideline 422, no effects are expected with C.I.<br />

<strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong>, a chrome antimony titanium dioxide rutile.<br />

3.2.1 Toxicokinetics, Metabolism and Distribution<br />

Concentration of chromium and antimony were analysed in liver and kidney of rats after oral<br />

exposure to C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> in a <strong>90</strong>-days feeding study at doses of 0, 10, 100, 1000, 10,000<br />

mg/kg diet, respectively (corresponding to 0, 0.5, 5, 50, 500 mg/kg b.w./day) (Bomhard E. et al.,<br />

1982) (see section 3.2.5): The chemical analysis included the determination of chromium and<br />

antimony in liver and kidney of 5 rats per gender per dose group after 1, 2 and 3 months of<br />

exposure. The detection limit for antimony was 5 µg/kg tissue and for chromium 2 µg/kg.<br />

In male and female rats the antimony concentrations in liver and kidney were below the detection<br />

limit at doses up to 1,000 ppm (50 mg /kg b.w./day). In the high dose groups the antimony levels<br />

slightly increased with exposure duration and reached max. 27 µg/kg in the liver of males (range<br />

15-40 µg/kg) and 17 µg/kg in females (kidney 14 µg/kg in males and 15 µg/kg in females). These<br />

traces most likely originate from the content of acid-soluble components (10 –20 mg antimony /kg<br />

pigment, that is 5 – 10 µg/kg b.w. or 125 - 250 µg/kg organ weight at the highest dose) and<br />

therefore do not indicate bioavailability of the pigment itself. Anyhow, the traces are considered to<br />

have no toxicological significance. No measurable effect on chromium content of liver and kidney<br />

at any dose level and exposure duration was detected in male and female rats.<br />

Conclusion<br />

In a <strong>90</strong> day feeding study on rats (up to 500 mg C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> /kg b.w./day) no<br />

bioavailability was demonstrated. However, traces of antimony may be available from the acidsoluble<br />

impurities of the pigment.<br />

3.2.2 Acute Toxicity<br />

The acute oral toxicity of C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> was investigated in male and female Sprague<br />

Dawley rats with an LD 50 greater than 10,0000 mg/kg body weight (BASF AG, 1978). The test<br />

followed in principle the procedure described in OECD guideline 401 and is valid with restrictions<br />

to judge the acute oral toxicity (validity 2). Ten rats per gender received a single oral administration<br />

of the test substance No deaths occurred after administration and during the 14 days post<br />

observation period. No substance related effects were found on body weight development and no<br />

adverse effects were reported after necropsy.<br />

Conclusion<br />

There was no acute toxicity at oral doses of 10000 mg/kg body weight .<br />

3.2.3 Irritation<br />

Skin Irritation<br />

Following the experimental design according to Federal Register 38, No. 187, § 1500.41, S. 27019,<br />

27. Sept. 1973, the application of 50% C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> in water to the intact skin of 6 rabbits<br />

resulted in slight irritation after <strong>24</strong> h (slight edema in 3/6 animals) and similar effects were seen on<br />

abraded skin (slight edema in 4/6 animals); no edema was observed after 72 h and 8 d, respectively.<br />

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OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

The evaluation of erythema could not be performed due to treatment related colouring of the skin<br />

(overall primary skin irritation value 0.58) (BASF AG, 1978). This staining of the skin by the test<br />

substance appears to be superficial, however, as another study has shown that it could be removed<br />

by washing with soap (Bayer AG, 1997). The results of the study are acceptable based on the<br />

experimental protocol applied (validity 2).<br />

Conclusion<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> is considered minimally irritating to the rabbit skin due to both the slight<br />

degree and the reversibility of the effects after 8 days as well as the six times longer exposure<br />

period to the test material under occlusive conditions in the protocol of Draize.<br />

Eye Irritation<br />

Following the experimental design according to Federal Register 38, No. 187, § 1500.42, S. 27019,<br />

27. Sept. 1973, no effects on cornea and iris were observed <strong>24</strong>, 48 and 72 h after instillation of the<br />

test substance (BASF AG, 1978). Concerning effects on conjunctivae slight irritation (slight<br />

reddening and secretion) was observed after <strong>24</strong> h, these effects were reversible (after 72 h no<br />

secretion and only slight reddening in 3 out of 6 rabbits; overall primary irritation value 2,22). The<br />

result indicates a mechanically mediated slight irritation of the mucous membrane due to the<br />

instillation of test substance particles into the eyes. No substance related staining of the eye was<br />

observed. The results of the study are acceptable based on the experimental protocol applied<br />

(validity 2).<br />

Conclusion:<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> may be slightly irritating to the eye.<br />

3.2.4 Sensitisation<br />

No data available. The substance contains chromium, but this was proven to be not bioavailable.<br />

3.2.5 Repeated Dose Toxicity<br />

In a feeding study (Bomhard E. et al., 1982) which followed essentially OECD guideline 408 rats<br />

received 0, 10, 100, 1000, 10000 mg C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> per kg diet (corresponding to 0, 0.5, 5,<br />

50, 500 mg/kg b.w./day) for <strong>90</strong> days. 15 animals per dose per gender were used for toxicological<br />

investigations (30 animals per gender in the control group) and additionally 10 animals per dose and<br />

gender for analytical investigations (control 20 animals per gender). Rats were observed daily; food<br />

consumption and body weight gain were determined once per week. Haematology, urinalysis and<br />

clinical and biochemical investigations were conducted after one month and at the end of the study<br />

(no post exposure observation period). Organ weights were determined at necropsy (thyroid gland,<br />

thymus, heart, lung, liver, spleen, kidneys, adrenal glands, and gonads). Complete histopathological<br />

investigations (above mentioned organs studied plus aorta, eyes, intestine, femur, brain, urinary<br />

bladder, pituitary, cervical lymph nodes, stomach, oesophagus, epididymides, pancreas, prostate,<br />

seminal vesicle, bone marrow of sternum, trachea, uterus, and skeletal muscles) were performed on<br />

5 rats per gender of control and the high dose group.<br />

No deaths, no overt signs of reactions to the treatment, no effects on body weight gain (similar food<br />

consumption in all groups) or organ weights, no treatment related findings from haematological or<br />

biochemical investigations and urinalysis were detected. No macroscopic pathological changes<br />

attributable to treatment and no treatment related effects in histopathology were observed. Since no<br />

substance related effects were observed up to the highest dose tested the NOEL and NO(A)EL of<br />

8<br />

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OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

this study is definded to be 500 mg/kg body weight. The study followed good scientific principles<br />

as to experimental design and reporting and is therefore considered valid (validity 2).<br />

Conclusion<br />

In a <strong>90</strong> day feeding study on rats doses up to 500 mg/kg bw/day resulted in no adverse effects in<br />

clinical observations, haematology, urine analysis, clinical chemistry and macro- and microscopical<br />

pathology.<br />

NOAEL = 500 mg/kg b.w./day (highest dose tested)<br />

3.2.6 Mutagenicity<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> has no mutagenic activity in in vitro studies according to current guideline<br />

standards. A suspension of the insoluble test substance induced no gene mutation in bacterial<br />

reverse mutation assay (comparable to OECD guideline 471 & 472; max. concentration 5 mg/plate;<br />

no cytotoxicity) on Salmonella typhimurium (Corning Hazelton, 1995) strain TA98, TA100,<br />

TA1535, TA1537, TA1538, and on E. coli WP2uvrA (Corning Hazelton, 1996) and in the mouse<br />

lymphoma assay (comparable to the OECD guideline 476, max. concentration 100 µg/ml, no<br />

cytotoxicity) (Corning Hazelton, 1996), each with and without metabolic activation. Furthermore,<br />

no aneugenic or clastogenic activity was observed in the micronucleus test on V79 Chinese hamster<br />

lung cells with and without metabolic activation (according to the proposed new OECD guideline<br />

for the in vitro micronucleus test; max. concentration 25 µg/ml; no cytotoxicity) (BASF AG, 2001).<br />

Conclusion<br />

All in vitro studies performed followed current guidelines and are thus acceptable and valid as<br />

regards both experimental design and reliabiltiy of the results derived thereof. C.I. <strong>Pigment</strong> <strong>Brown</strong><br />

<strong>24</strong> induced, with or without addition of a metabolic activation system, no gene mutation in bacteria<br />

or mammalian cells and no clastogenic or aneugenic effects in mammalian cells. There are no invitro<br />

data to indicate that C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> would exhibit a genotoxic potential in vivo. No<br />

data are available on the genotoxicity of C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> in vivo.<br />

3.2.7 Carcinogenicity<br />

No data available.<br />

3.2.8 Toxicity for Reproduction<br />

No effects on organ weights and macro- and micro-histopathology of gonads (testes, epididymides,<br />

prostate, seminal vesicle, ovary and uterus) were observed in the <strong>90</strong> day feeding study on rats at<br />

doses up to 500 mg/kg bw/day (see section 3.2.5).<br />

3.2.9 Developmental Toxicity<br />

A developmental toxicity study is not considered necessary because the substance showed no<br />

bioavailability with toxicological relevance after oral exposure (see section 3.2.5). In analogy to C.I.<br />

<strong>Pigment</strong> Yellow 53 (a nickel antimony titanium dioxide rutile with similar data on bioavailability to<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> (Endriß H., 1998) which resulted in no reproductive or developmental<br />

effects in a screening test according to OECD guideline 422, no effects are expected with C.I.<br />

<strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong>, a chrome antimony titanium dioxide rutile.<br />

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OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

3.3 Initial Assessment for Human Health<br />

There is no acute toxicity of C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> after oral exposure, based on the following<br />

data: No death of male and female rats up to 10,000 mg/kg body weight with no toxic signs.<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> is not irritating to the rabbit skin and slightly irritating to the rabbit eye. No<br />

data are available on sensitisation; the data on bioavailability of the chromium (sensitising<br />

component of the pigment) indicated no sensitising potential.<br />

In a <strong>90</strong> day feeding study on rats doses up to 500 mg/kg bw/day resulted in no adverse effects in<br />

clinical observations, haematology, urine analysis, clinical chemistry and macro- and microscopical<br />

pathology [NOAEL = 500 mg/kg bw/day (highest dose tested)] . In this study, no increase in<br />

chromium concentration was detected in liver and kidney of rats and only traces of antimony<br />

(below 30 µg/kg tissue) were found, but only in the high dose group. These traces indicate very low<br />

bioavailability of the antimony contained in the pigment. Hence, antimony is considered to have no<br />

toxicological significance.<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> induced, with or without addition of a metabolic activation system, no gene<br />

mutation either in bacteria or in mammalian cells and no clastogenic or aneugenic effects in<br />

mammalian cells.<br />

There are no specific studies on carcinogenicity or toxicity to reproduction available.<br />

No effects on gonads were observed in the <strong>90</strong> day feeding study on rats at doses up to 500 mg/kg<br />

bw/day (see above). A developmental toxicity study is not considered necessary because the<br />

substance showed no bioavailability with toxicological relevance after oral exposure (see above). In<br />

analogy to C.I. <strong>Pigment</strong> Yellow 53 (a nickel antimony titanium dioxide rutile with similar data on<br />

bioavailability to C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong>), which resulted in no reproductive or developmental<br />

effects in a screening test according to OECD guideline 422, no effects are expected with C.I.<br />

<strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong>, a chromium antimony titanium dioxide rutile.<br />

4 HAZARDS TO THE ENVIRONMENT<br />

The following acute toxicity tests with aquatic organisms are available:<br />

Leuciscus idus: LC 50 (96 h) > 10000 mg/l; NOEC (96 h) = 10000 mg/l (BASF AG, 2000b)<br />

Daphnia magna: EC 50 (48 h) > 100 mg/l; EC 0 (48 h) 100 mg/l (BASF AG, 2000c)<br />

Scenedesmus subspicatus: ErC 50 (72 h) > 100 mg/l; ErC 10 (72 h) > 100 mg/l;<br />

10<br />

NOEC (72 h) 100 mg/l (BASF AG, Project No. 99/0484/60/1, 2000c)<br />

Pseudomonas putida: EC 50 (30 min) > 10000 mg/l; EC 10 (30 min) > 10000 mg/l (BASF AG, 1997)<br />

All values were related to nominal concentrations of suspensions (tests on fish and bacteria) or<br />

aqueous extracts (test on daphnids and algae), no analytical monitoring was performed. In previous<br />

analytical studies on aqueous extracts of a suspension of this insoluble pigment it has been shown,<br />

that the expected concentration of the substance in the extract is below the detection limit of the<br />

analytical method (concentration of total amount of chromium, antimony and titany in a filtrate<br />

from a 100 mg/l stock solution has been


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

No data are available on terrestrial organisms.<br />

The cited studies are carried out according to nationally and/or internationally accepted guidelines<br />

and are considered as valid.<br />

4.1 Initial Assessment for the Environment<br />

C.I. <strong>Pigment</strong> brown <strong>24</strong> is a solid, complex inorganic coloured pigment, based on titanium dioxide<br />

with chromium (III) and antimony (V) ions partially replacing titanium ions in the rutile lattice. It is<br />

practically inert and has a melting point above 1000 °C. The vapour pressure is estimated to be<br />

negligible. C.I. <strong>Pigment</strong> brown <strong>24</strong> has an extremely low solubility in water; the concentration of<br />

chromium and antimony in filtrates (10 g/l) has been measured by atomic absorption to be <br />

10000 mg/l; Daphnia magna: EC50 (48 h) > 100 mg/l; Desmodesmus subspicatus: EC50 (72 h)><br />

100 mg/l; Pseudomonas putida: EC50 (30 min) > 10000 mg/l.<br />

The substance is not acutely toxic to aquatic organisms (fish, invertebrates and algae) in tests with<br />

either aqueous eluates or suspensions prepared with nominal concentrations far exceeding its water<br />

solubility.<br />

No data are available on terrestrial organisms.<br />

The substance is inorganic and thus not biologically degradable. According to the low water<br />

solubility and the structural properties of the pigment, bioaccumulation is not expected.<br />

5 RECOMMENDATIONS<br />

This chemical is currently of low priority for further work based on a low hazard potential.<br />

UNEP PUBLICATIONS 11


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

6 REFERENCES<br />

BASF AG (1978), department of toxicology, unpublished data, substance 77/146, 28.03.1978.<br />

BASF AG (1988), department of toxicology, unpublished data, Project No. 10F0066/885110,<br />

28.10.1988.<br />

BASF AG (1997), department of ecology, unpublished data, Project No. 01/88/0121, Jan. 1997.<br />

BASF AG (2000a), Safety data sheet Sicotan Gelb L2011, 06.04.2000.<br />

BASF AG (2000b), department of ecology, unpublished data, Project No. 99/0484/50/1, Jan. 2000.<br />

BASF AG (2000c), department of ecology, unpublished data, Project No. 99/0484/60/1, 04.05.<br />

2000.<br />

BASF AG (2001), product safety, unpublished data, Report No.: 33MO278/994093.<br />

BASF AG (2002), personal communication, 12.08.2002.<br />

BASF AG (2002), personal communication, estimation by means of CEH Marketing Research<br />

Report "PIGMENTS" 2001 by the Chemical Economics Handbook-SRI International; 575.0000A -<br />

575.0000F”.<br />

Bayer AG (1997), basic data set, unpublished 20th Feb. 1997.<br />

Bomhard E. et al. (1982), Toxicol. Lett. 14, 189-194.<br />

Corning Hazelton (1995), CHV Study No. 16595-0-409, June 1995, sponsored by Color <strong>Pigment</strong>s<br />

Manufacturers Association Inc.<br />

Corning Hazelton (1996), CHV Study No. 16595-0-431, Apr. 1996, sponsored by Color <strong>Pigment</strong>s<br />

Manufacturers Association Inc.<br />

Endriß H. (1998), Inorganic coloured pigments today, Curt R. Vincentz Verlag, Hannover.<br />

MAK-Begründung (1983), Nickeltitangelb, 7. Feb. 1983.<br />

12<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ANNEX<br />

Date of the literature search (August 27, 2001)<br />

Toxicology<br />

JETOC<br />

RTECS<br />

AGRICOLA<br />

CABA<br />

CANCERLIT<br />

TOXCENTER<br />

TOXLINE<br />

JICST-EPLUS<br />

LIFESCI<br />

TOXLIT<br />

EMBASE<br />

ESBIOBASE<br />

EMBAL<br />

HEALSAFE<br />

CSNB<br />

MEDLINE<br />

IRIS<br />

ATSDR TOX. PROFILES<br />

ATSDR TOX: FAQS<br />

CHEMFINDER<br />

CIVS<br />

GESTIS<br />

GINC<br />

NICNAS<br />

NTP<br />

Ecology<br />

AQUASCI<br />

BIOSIS<br />

EMBASE<br />

ESBIOBASE.<br />

LIFESCI<br />

OCEAN<br />

POLLUAB<br />

SCISEARCH<br />

TOXCENTER<br />

TOXLINE<br />

ULIDAT<br />

DATALOG<br />

CHEMFATE<br />

BIODEG<br />

AQUIRE<br />

HSDB<br />

UNEP PUBLICATIONS 13


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

I U C L I D<br />

D a t a<br />

S e t<br />

Existing Chemical ID: <strong>68186</strong>-<strong>90</strong>-3<br />

<strong>CAS</strong> No. <strong>68186</strong>-<strong>90</strong>-3<br />

EINECS Name C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong><br />

EC No. 269-052-1<br />

Molecular Formula <br />

Producer Related Part<br />

Company:<br />

Creation date:<br />

Substance Related Part<br />

Company:<br />

Creation date:<br />

Memo:<br />

BASF AG<br />

07-MAY-1996<br />

BASF AG<br />

07-MAY-1996<br />

master<br />

Printing date:<br />

Revision date:<br />

Date of last Update:<br />

01-DEC-2004<br />

26-NOV-2004<br />

Number of Pages: 44<br />

Chapter (profile): Chapter: 1, 2, 3, 4, 5, 6, 7, 8, 10<br />

Reliability (profile): Reliability: without reliability, 1, 2, 3, 4<br />

Flags (profile): Flags: without flag, SIDS<br />

14<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

GENERAL INFORMATION ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

1.0.1 Applicant and Company Information<br />

Type:<br />

lead organisation<br />

Name:<br />

BASF AG<br />

Contact Person: Product Safety Date:<br />

Dr. Hubert Lendle<br />

GUP/Z - Z570<br />

Street:<br />

Carl-Bosch-Strasse<br />

Town:<br />

67056 Ludwigshafen<br />

Country:<br />

Germany<br />

Phone: +49 621 60 44712<br />

Telefax: +49 621 60 6644712<br />

Email:<br />

hubert.lendle@basf-ag.de<br />

Homepage:<br />

www.basf-ag.com<br />

Flag:<br />

01-APR-2004<br />

Type:<br />

Name:<br />

Country:<br />

Flag:<br />

13-DEC-2001<br />

Type:<br />

Name:<br />

Country:<br />

Flag:<br />

13-NOV-2001<br />

Type:<br />

Name:<br />

Country:<br />

Flag:<br />

13-NOV-2001<br />

Type:<br />

Name:<br />

Country:<br />

Flag:<br />

13-NOV-2001<br />

Type:<br />

Name:<br />

Country:<br />

Flag:<br />

13-NOV-2001<br />

Critical study for SIDS endpoint<br />

cooperating company<br />

Bayer AG<br />

Germany<br />

Critical study for SIDS endpoint<br />

cooperating company<br />

Broll Buntpigmente GmbH<br />

Germany<br />

Critical study for SIDS endpoint<br />

other: cooperating organisation<br />

Color <strong>Pigment</strong>s Manufacturers Ass. (CMPA), Inc.<br />

United States<br />

Critical study for SIDS endpoint<br />

cooperating company<br />

Dr. Hans Heubach GmbH & Co. KG<br />

Germany<br />

Critical study for SIDS endpoint<br />

cooperating company<br />

Ishihara Sangyo Kaisha, Ltd.<br />

Japan<br />

Critical study for SIDS endpoint<br />

Type:<br />

Name:<br />

Country:<br />

Flag:<br />

13-NOV-2001<br />

cooperating company<br />

Kawamura Chemical Co.<br />

Japan<br />

Critical study for SIDS endpoint<br />

UNEP PUBLICATIONS 15


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

GENERAL INFORMATION ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

1.0.2 Location of Production Site, Importer or Formulator<br />

1.0.3 Identity of Recipients<br />

1.0.4 Details on Category/Template<br />

1.1.0 Substance Identification<br />

1.1.1 General Substance Information<br />

Substance type: inorganic<br />

Physical status: solid<br />

Purity:<br />

> 99 - % w/w<br />

Colour:<br />

yellow<br />

Odour:<br />

odourless<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

14-FEB-2003 (1)<br />

1.1.2 Spectra<br />

1.2 Synonyms and Tradenames<br />

C.I. 77310<br />

Flag:<br />

07-MAY-1996<br />

non confidential, Critical study for SIDS endpoint<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> (9CI)<br />

Flag:<br />

07-MAY-1996<br />

non confidential, Critical study for SIDS endpoint<br />

Chromantimontitanlederfarbenrutil<br />

Flag:<br />

07-MAY-1996<br />

non confidential, Critical study for SIDS endpoint<br />

Chrome antimony titanate buff<br />

Flag:<br />

07-MAY-1996<br />

non confidential, Critical study for SIDS endpoint<br />

Chrome antimony titanium buff rutile<br />

Flag:<br />

07-MAY-1996<br />

non confidential, Critical study for SIDS endpoint<br />

Chrome titanium yellow<br />

Flag:<br />

07-MAY-1996<br />

non confidential, Critical study for SIDS endpoint<br />

<strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong><br />

16<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

GENERAL INFORMATION ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Flag:<br />

07-MAY-1996<br />

non confidential, Critical study for SIDS endpoint<br />

1.3 Impurities<br />

1.4 Additives<br />

1.5 Total Quantity<br />

Remark: Production quantity (Year of reference: 2001):<br />

Europe<br />

: 5000 - 10000 t/a<br />

includes Germany: 5000 - 10000 t/a<br />

USA<br />

: 1000 - 5000 t/a<br />

Asia<br />

: 1000 - 5000 t/a<br />

includes Japan : 1000 - 5000 t/a<br />

Flag:<br />

04-DEC-2001<br />

World<br />

: approx. 15000 t/a<br />

non confidential, Critical study for SIDS endpoint<br />

1.6.1 Labelling<br />

Labelling:<br />

no labelling required (no dangerous properties)<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

14-NOV-2002 (1)<br />

1.6.2 Classification<br />

Classified:<br />

no classification required (no dangerous properties)<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

14-NOV-2002 (1)<br />

1.6.3 Packaging<br />

1.7 Use Pattern<br />

Type:<br />

Category:<br />

Flag:<br />

07-MAY-1996<br />

Type:<br />

Category:<br />

Flag:<br />

07-MAY-1996<br />

type<br />

Use resulting in inclusion into or onto matrix<br />

non confidential, Critical study for SIDS endpoint<br />

industrial<br />

Paints, lacquers and varnishes industry<br />

non confidential, Critical study for SIDS endpoint<br />

UNEP PUBLICATIONS 17


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

GENERAL INFORMATION ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Type:<br />

Category:<br />

Flag:<br />

07-MAY-1996<br />

Type:<br />

Category:<br />

Flag:<br />

07-MAY-1996<br />

industrial<br />

Polymers industry<br />

non confidential, Critical study for SIDS endpoint<br />

use<br />

Colouring agents<br />

non confidential, Critical study for SIDS endpoint<br />

1.7.1 Detailed Use Pattern<br />

1.7.2 Methods of Manufacture<br />

Type:<br />

Remark:<br />

Production<br />

Doted rutile pigments are manufactured by reacting finely<br />

divided metal oxides, hydroxides or carbonates in the solid<br />

state at a temperature of 1000 to 1,200 °C. The production<br />

is based on reactive anatase, or titanium dioxide<br />

hydrolysate containing sulfuric acid, and on the oxidation<br />

of trivalent antimony with oxygen in the form of nitric acid<br />

or air. For the production of C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> the<br />

chromium raw materials are used.<br />

The reactions proceed more readily if the components are<br />

reactive, finely divided and intimately mixed. Adding<br />

mineralizers promotes solid-state reaction during<br />

calcination, which is performed either continuously in a<br />

rotary, annular or tunnel furnace, or batchwise in a<br />

directly fired car-bottom or rotary-hearth furnace. After<br />

calcination, the resulting clinker is wet-ground and any<br />

soluble salts are washed out. The product is dried either<br />

in a spray-drying tower, when low-dusting, free-flowing<br />

grades are required, or by standard means, which, however,<br />

necessitates subsequent grinding to a pigment powder.<br />

Raw-material dust, and gases (e.g. SO3 and NOx), emitted<br />

during the calcination step are removed from the flue gas by<br />

dust separators and alkaline flue scrubbers. The raw-material<br />

dust can be recycled. Soluble metal salts can be removed by<br />

neutral precipitation in the waste-water<br />

treatment plant, and suspended pigment particles can be<br />

mechanically separated from the water from washing and<br />

purification steps. Altogether, only a small amount of waste<br />

is produced with each tonne of product.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (2)<br />

Type:<br />

Production<br />

Remark: The finished C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> contains about 2 to 6 %<br />

chromium(III) and 8.5 to 14 % antimony(V) (all data<br />

calculated as metal).<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (3)<br />

18<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

GENERAL INFORMATION ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

1.8 Regulatory Measures<br />

1.8.1 Occupational Exposure Limit Values<br />

Type of limit:<br />

Limit value:<br />

MAK (DE)<br />

other: no MAK- or BAT-value established<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

14-FEB-2003 (4)<br />

1.8.2 Acceptable Residues Levels<br />

1.8.3 Water Pollution<br />

Classified by: KBwS (DE)<br />

Labelled by: KBwS (DE)<br />

Class of danger: 0 (generally not water polluting)<br />

Remark: ID-Number: 1956<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

14-NOV-2002 (5)<br />

Classified by: other: VwVwS (Germany) of 17.05.1999, Annex 3<br />

Labelled by: other: VwVwS (Germany) of 17.05.1999, Annex 3<br />

Class of danger: 0 (generally not water polluting)<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

14-NOV-2002 (1)<br />

1.8.4 Major Accident Hazards<br />

1.8.5 Air Pollution<br />

1.8.6 Listings e.g. Chemical Inventories<br />

Type:<br />

TSCA<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

13-NOV-2001 (6)<br />

Type:<br />

DSL<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

13-NOV-2001 (6)<br />

Type:<br />

AICS<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

13-NOV-2001 (6)<br />

Type:<br />

PICCS<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

13-NOV-2001 (6)<br />

UNEP PUBLICATIONS 19


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

GENERAL INFORMATION ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Type:<br />

EINECS<br />

Additional Info: EINECS No. 269-052-1<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

21-FEB-2002 (6)<br />

Type:<br />

ECL<br />

Additional Info: ECL Serial No. KE-07865<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

21-FEB-2002 (6)<br />

1.9.1 Degradation/Transformation Products<br />

EINECS-Name:<br />

No hazardous decomposition products if stored and handled as<br />

prescribed/indicated.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

14-NOV-2002 (1)<br />

1.9.2 Components<br />

1.10 Source of Exposure<br />

1.11 Additional Remarks<br />

1.12 Last Literature Search<br />

Type of Search: Internal and External<br />

Chapters covered: 3, 4<br />

Date of Search: 19-NOV-2003<br />

25-NOV-2003<br />

1.13 Reviews<br />

-<br />

20<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

PHYSICO-CHEMICAL DATA ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

2.1 Melting Point<br />

Value:<br />

> 1000 degree C<br />

Reliability: (4) not assignable<br />

Manufacturer / producer data without proof<br />

Flag:<br />

Critical study for SIDS endpoint<br />

04-DEC-2000 (7)<br />

2.2 Boiling Point<br />

2.3 Density<br />

Type:<br />

Value:<br />

density<br />

= 4 - 5 g/cm³ at 20 degree C<br />

Method: other: (DIN-ISO 787/10)<br />

GLP:<br />

no<br />

Reliability: (4) not assignable<br />

Manufacturer / producer data without proof<br />

Flag:<br />

Critical study for SIDS endpoint<br />

14-FEB-2003 (7)<br />

2.3.1 Granulometry<br />

2.4 Vapour Pressure<br />

Remark:<br />

A negligible vapour pressure can be assumed for this mixed<br />

metal oxide.<br />

Flag:<br />

Critical study for SIDS endpoint<br />

14-FEB-2003 (8)<br />

2.5 Partition Coefficient<br />

2.6.1 Solubility in different media<br />

Solubility in:<br />

Water<br />

Remark:<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> has an extremely low solubility in<br />

water; the concentration of chromium and antimony in filtrates<br />

of a 10 g/l solution after 2h-stirring has been measured by<br />

atomic absorption to be


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

PHYSICO-CHEMICAL DATA ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

GLP:<br />

no<br />

Result:<br />

The pH-value has been determined from a pigment suspension<br />

having a concentration of 50 g/l.<br />

Reliability: (4) not assignable<br />

Manufacturer / producer data without proof<br />

Flag:<br />

Critical study for SIDS endpoint<br />

14-FEB-2003 (7)<br />

2.6.2 Surface Tension<br />

2.7 Flash Point<br />

Remark:<br />

not applicable<br />

Reliability: (4) not assignable<br />

Flag:<br />

Critical study for SIDS endpoint<br />

04-DEC-2000 (7)<br />

2.8 Auto Flammability<br />

2.9 Flammability<br />

2.10 Explosive Properties<br />

2.11 Oxidizing Properties<br />

2.12 Dissociation Constant<br />

2.13 Viscosity<br />

2.14 Additional Remarks<br />

22<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ENVIRONMENTAL FATE AND PATHWAYS ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

3.1.1 Photodegradation<br />

Test substance:<br />

Remark:<br />

Flag:<br />

12-MAR-2003<br />

other TS: Chromantimontitanlederfarbenrutil<br />

No data are available<br />

Critical study for SIDS endpoint<br />

3.1.2 Stability in Water<br />

3.1.3 Stability in Soil<br />

3.2.1 Monitoring Data (Environment)<br />

3.2.2 Field Studies<br />

3.3.1 Transport between Environmental Compartments<br />

Method:<br />

Remark:<br />

Flag:<br />

12-MAR-2003<br />

other<br />

No data are available.<br />

Critical study for SIDS endpoint<br />

3.3.2 Distribution<br />

Media:<br />

Method:<br />

air - biota - sediment(s) - soil - water<br />

Calculation according Mackay, Level I<br />

Remark:<br />

Distribution modelling is not applicable since several<br />

physical parameters (molecular weight, water solubility,<br />

vapour pressure and partition coefficient) are not<br />

available.<br />

Flag:<br />

Critical study for SIDS endpoint<br />

11-DEC-2001 (10)<br />

3.4 Mode of Degradation in Actual Use<br />

3.5 Biodegradation<br />

Method:<br />

other<br />

Remark:<br />

C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> is an inorganic substance,<br />

biodegradation is therefore not assumed.<br />

Flag:<br />

Critical study for SIDS endpoint<br />

12-MAR-2003 (8)<br />

3.6 BOD5, COD or BOD5/COD Ratio<br />

UNEP PUBLICATIONS 23


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ENVIRONMENTAL FATE AND PATHWAYS ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

3.7 Bioaccumulation<br />

Year: 2002<br />

Test substance: as prescribed by 1.1 - 1.4<br />

Remark:<br />

No data on bioaccumulation are available. However, regarding<br />

the extremely low water solubility, experiences from rodent<br />

investigations and the structure-related inert properties of<br />

the rutil, bioavailability and therefore bioconcentration is<br />

not expected.<br />

Flag:<br />

Critical study for SIDS endpoint<br />

12-MAR-2003 (8)<br />

3.8 Additional Remarks<br />

<strong>24</strong><br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ECOTOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

AQUATIC ORGANISMS<br />

4.1 Acute/Prolonged Toxicity to Fish<br />

Type:<br />

static<br />

Species:<br />

Leuciscus idus (Fish, fresh water)<br />

Exposure period: 96 hour(s)<br />

Unit: mg/l Analytical monitoring: no<br />

LC0: >= 1000<br />

Method:<br />

other: Bestimmung der akuten Wirkung von Stoffen auf Fische.<br />

Arbeitskreis "Fischtest" im Hauptausschuss "Detergentien"<br />

(15.10.73)<br />

Year: 1977<br />

GLP:<br />

no<br />

02-OCT-2001 (11)<br />

Type:<br />

static<br />

Species:<br />

Leuciscus idus (Fish, fresh water)<br />

Exposure period: 96 hour(s)<br />

Unit: mg/l Analytical monitoring: no<br />

NOEC: = 10000<br />

LC50: > 10000<br />

Method: other: DIN 38412 Part 15<br />

Year: 1982<br />

GLP:<br />

no<br />

Test substance: as prescribed by 1.1 - 1.4<br />

Remark:<br />

Cloudy and coloured test solution; undissolved test<br />

substance visible on the bottom of aquaria; results on the<br />

basis of nominal concentrations,<br />

Result:<br />

RESULTS: EXPOSED<br />

- No mortality after 96 h<br />

- No symptoms observed at 1, 4, <strong>24</strong>, 48, 72, 96h<br />

RESULTS: CONTROL<br />

- No animals showed adverse effects<br />

- Positive control conducted with Chloroacetamide, LC50<br />

(48h) =32 mg/l (normal sensitivity)<br />

Test condition: DILUTION WATER<br />

according to DIN 38412, part 11 (Oct. 1982)<br />

TEST SYSTEM<br />

- concentrations: 0, 5000, 10000 mg/l<br />

- Number of animals per test concentration: 10<br />

- Loading: 4.7 g fish/l test water<br />

- Test temperature: 21 degree C<br />

- pH 7.5-8.3 during exposure in all 3 groups<br />

- Oxygen content during exposure: 6.9-8.5 mg/l in all 3<br />

groups<br />

- Test parameter: mortality and symptoms<br />

- Effects checked after directing the fish towards the front<br />

pane of aquaria (cloudy content, see remark); at the end<br />

of test period (96h) fish transfered into clean water for<br />

determination of symptoms.<br />

Reliability: (2) valid with restrictions<br />

Comparable to OECD guideline 203<br />

Flag:<br />

Critical study for SIDS endpoint<br />

12-MAR-2003 (12)<br />

UNEP PUBLICATIONS 25


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ECOTOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

4.2 Acute Toxicity to Aquatic Invertebrates<br />

Type:<br />

static<br />

Species:<br />

Daphnia magna (Crustacea)<br />

Exposure period: 48 hour(s)<br />

Unit: mg/l Analytical monitoring: no<br />

EC0: >= 100<br />

EC50: > 100<br />

EC100: > 100<br />

Method: OECD Guide-line 202<br />

Year: 1984<br />

GLP:<br />

yes<br />

Test substance: as prescribed by 1.1 - 1.4<br />

Method: Test also according to EEC directive 92/32/EEC Annex V, C.2<br />

(1992), EPA OPPTS850.1010 (1996), ISO 6341 (1989)<br />

Result:<br />

RESULTS: EXPOSED<br />

- Nominal concentrations: 0, 12.5, 25, 50, 100 mg/l<br />

- Effect data (Immobilisation): No immobilisation at any<br />

dose group or control; other effects: no<br />

Test condition:<br />

RESULTS CONTROL: valid negative (immobility 0%) and positive<br />

control<br />

STOCK AND TEST SOLUTION AND THEIR PREPARATION<br />

Unsoluble TS (water solubility < 1 mg/l) stirred in the M4<br />

medium (see dilution water) for ca. 20 h at ca. 20 °C;<br />

undissolved TS removed by filtration with a membrane filter<br />

(pore width 0.2 µm); nominal concentration of the filtrate<br />

100 mg/l; further dilution of this filtrate with M4 medium;<br />

prepared nominal concentrations:<br />

control, 12.5, 25, 50, 100 mg/l.<br />

DILUTION WATER<br />

M4 medium<br />

TEST SYSTEM<br />

- Test volume: 10 ml<br />

- Number of replicates (individuals/vessel): 4 (5)<br />

- Test temperature: 20.4-20.5 °C<br />

- Dissolved oxygen: 8.2-8.5 mg/l<br />

- pH: 8.1-8.4<br />

MONITORING OF TEST SUBSTANCE CONCENTRATION: Test performed<br />

with an aqueous extract (filtrate) of the TS. Test performed<br />

without concentration control analysis because the recovery<br />

rate in the filtrate was below the detection limit.<br />

STATISTICS:<br />

Results allowed no statistical evaluation of the data.<br />

Reliability: (1) valid without restriction<br />

guideline study<br />

Flag:<br />

Critical study for SIDS endpoint<br />

12-MAR-2003 (13)<br />

4.3 Toxicity to Aquatic Plants e.g. Algae<br />

Species: other algae: Scenedesmus subspicatus Chodat SAG 86.81<br />

Endpoint:<br />

growth rate<br />

26<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ECOTOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Exposure period: 72 hour(s)<br />

Unit: mg/l Analytical monitoring: no<br />

NOEC: >= 100<br />

LOEC: > 100<br />

EC10: > 100<br />

EC50: > 100<br />

EC<strong>90</strong> : > 100<br />

Method:<br />

OECD Guide-line 201 "Algae, Growth Inhibition Test"<br />

Year: 1984<br />

GLP:<br />

yes<br />

Test substance: as prescribed by 1.1 - 1.4<br />

Method: Test also according to EEC directive 92/69/EEC, Annex V,<br />

Part C.3. (1992) and EPA OPPTS 850.5400 (1996)<br />

Remark:<br />

MONITORING OF TEST SUBSTANCE CONCENTRATION:<br />

Test performed with an aqueous extract (filtrate) of the TS.<br />

Test performed without concentration control analysis<br />

because the recovery rate in a filtrate is below the<br />

detection limit (see also data in section 4.2).<br />

Result:<br />

CONTROL<br />

In negative control cell multiplication factor after 72h:<br />

149-fold; positive control with potassium dichromate EC50<br />

(72h)= 0.41 mg/l;<br />

INHIBITION OF ALGAL BIOMASS AFTER 72h<br />

Concentration in mg TS/l<br />

0 1.56 3.13 6.25 12.5 25 50 100<br />

Inhibition<br />

in % of control 0 -1.6 -4.5 -1.4 0.5 -1.0 1.0 -15.4<br />

EbC10 (72h) > 100 mg/l<br />

EbC50 (72h) > 100 mg/l<br />

EbC<strong>90</strong> (72h) > 100 mg/l<br />

INHIBITION OF GROWTH RATES AFTER 72h<br />

Concentration in mg TS/l<br />

0 1.56 3.13 6.25 12.5 25 50 100<br />

Inhibition<br />

in % of control 0 -0.7 -2.0 0.1 -0.3 -2.3 -1.0<br />

-4.0<br />

Test condition:<br />

ErC10 (72h) > 100 mg/l<br />

ErC50 (72h) > 100 mg/l<br />

ErC<strong>90</strong> (72h) > 100 mg/l<br />

STOCK SOLUTION AND DILUTION<br />

The test was performed with an aqueous extract (filtrate) of<br />

the test substance (water solubility < 1mg/l); TS stirred in<br />

demineralized water for ca. 20h at 20°C, undissolved TS<br />

removed by membrane filtration (pore size 0.2 µm), nominal<br />

concentration of the filtrate 125 mg/l, further dilution to<br />

nominal concentrations: 100, 50, 25, 12.5, 6.25, 3.13, 1.56<br />

mg/l.<br />

TEST MEDIUM<br />

prepared according to guideline (see above)<br />

PEFORMANCE OF THE TEST<br />

test temperature 23°C, max. difference 2°C;<br />

test vessels 250 ml Erlenmeyer flasks plugged with<br />

siliconsponge caps; test volume 100 ml;<br />

UNEP PUBLICATIONS 27


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ECOTOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

pH values in uninoculated tests 7.8-7.9 at start of<br />

experiments and 7.9 after 72 h, in inoculated tests pH<br />

7.6-7.8 after 72 h;<br />

test parameter:<br />

1) in vivo chlorophyll-a-fluorescence at 435 nM wavelength<br />

after 0, <strong>24</strong>, 48, 72 h;<br />

2) control culture: additionally cell counting after 72 h in<br />

a counting chamber<br />

STATISTICS<br />

EC values calculated by linear regression analysis from<br />

dose-response relationship; NOEC and LOEC: Duncan multiple<br />

range test at 95% significance level<br />

Reliability: (1) valid without restriction<br />

guideline study<br />

Flag:<br />

Critical study for SIDS endpoint<br />

12-MAR-2003 (14)<br />

4.4 Toxicity to Microorganisms e.g. Bacteria<br />

Type:<br />

aquatic<br />

Species:<br />

Pseudomonas fluorescens (Bacteria)<br />

Unit: mg/l Analytical monitoring: no<br />

EC0: > 10000<br />

Method:<br />

other<br />

Year: 1977<br />

GLP:<br />

no<br />

Method:<br />

Growth inhibition test according to Bringmann, G. & Kuehn,<br />

R.: Z.f. Wasser- und Abwasser-Forschung 10(3/4), 87-98<br />

(1977)<br />

11-DEC-2001 (15)<br />

Type:<br />

aquatic<br />

Species:<br />

Pseudomonas putida (Bacteria)<br />

Exposure period: 30 minute(s)<br />

Unit: mg/l Analytical monitoring: no<br />

EC10: > 10000<br />

EC50: > 10000<br />

EC<strong>90</strong> : > 10000<br />

Method:<br />

GLP:<br />

Test substance:<br />

Method:<br />

Result:<br />

Test condition:<br />

28<br />

other: DIN 38412 Part 27 (draft)<br />

no<br />

other TS: Sicotangelb K 1910 (C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong>; <strong>CAS</strong><br />

68286-<strong>90</strong>-3); purity ca. 100%<br />

Bacterial oxygen consumption test according to Robra, K.H.,<br />

gwf. Wasser-Abwasser 117, 80-86 (1976)<br />

The results show the nominal concentrations of the TS that<br />

inhibited oxygen consumption of the microorganisms.<br />

- Test solution stirred for 17 h at 293 °K and than used as<br />

dispersion (unsoluble in water) in the oxygen consumption<br />

test<br />

- test volume 100 ml (5 ml glucose [198 g/l] and 95 ml test<br />

substance including bacterial suspension)<br />

- assay batch aerated for 30 min<br />

- decline in concentration of dissolved oxygen measured in a<br />

flow cell<br />

- pH of the test mix: 7.2 (low dose) - 8.0 (high dose)<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ECOTOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

- temperature: 25°C<br />

- tested concentrations: control, 1250, 2500, 5000, 10000<br />

mg/l (nominal)<br />

Reliability: (2) valid with restrictions<br />

Acceptable, well documented study report which meets basic<br />

scientific principles.<br />

Flag:<br />

Critical study for SIDS endpoint<br />

12-DEC-2001 (16) (17)<br />

4.5 Chronic Toxicity to Aquatic Organisms<br />

4.5.1 Chronic Toxicity to Fish<br />

4.5.2 Chronic Toxicity to Aquatic Invertebrates<br />

UNEP PUBLICATIONS 29


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ECOTOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

TERRESTRIAL ORGANISMS<br />

4.6.1 Toxicity to Sediment Dwelling Organisms<br />

4.6.2 Toxicity to Terrestrial Plants<br />

4.6.3 Toxicity to Soil Dwelling Organisms<br />

4.6.4 Toxicity to other Non-Mamm. Terrestrial Species<br />

4.7 Biological Effects Monitoring<br />

4.8 Biotransformation and Kinetics<br />

4.9 Additional Remarks<br />

Memo: 1<br />

Remark:<br />

Sicotan Gelb K 2011 verhaelt sich in einem Organismus und<br />

in der Umwelt praktisch inert bzw. ist nicht bioverfuegbar.<br />

Dies wird bestaetigt durch die toxikologischen Daten und<br />

Daten zur oekotoxischen Wirkung.<br />

30<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

5.0 Toxicokinetics, Metabolism and Distribution<br />

Type:<br />

Toxicokinetics<br />

Species:<br />

rat<br />

No. of animals, males: 5<br />

No. of animals, females: 5<br />

Doses, males: 10, 100, 1000, 10000 mg/kg diet (0.5, 5, 50, 500<br />

mg/kg bw/day)<br />

Doses, females: 10, 100, 1000, 10000 mg/kg diet (0.5, 5, 50, 500<br />

mg/kg bw/day)<br />

Route of administration: oral feed<br />

Exposure time:<br />

<strong>90</strong> day(s)<br />

Method: other:comparable to OECD guideline 408<br />

GLP:<br />

no data<br />

Remark:<br />

Result:<br />

The detected traces of antimony (see results) most likely<br />

originate from the acid-soluble impurities of the pigment<br />

(10-20 mg antimony/kg pigment, that is 5-10 microgram/kg bw or<br />

125-250 microgram/kg organ weights at the highest dose) and<br />

therefore do not indicate bioavailability of the pigment<br />

itself.<br />

TOXICICITY<br />

No deaths, no overt signs of reactions to the treatment, no<br />

effects on body weight gain (similar food consumption in all<br />

groups) or organ weight, no treatment related findings<br />

from haematological or biochemical investigations and<br />

urinalysis.<br />

No macroscopic pathological changes attributable to<br />

treatment. No treatment related effects observed in<br />

histopathology.<br />

CHEMICAL ANALYSIS<br />

Antimony<br />

In males and females the Sb concentrations in liver and<br />

kidney were below the detection limit at doses up to 1000<br />

ppm. In the high dose groups the Sb levels slightly<br />

increased with exposure duration and reached max. 27 ppb in<br />

the liver (3 mo) of males (range 15-40 ppb) and 17 ppb in<br />

females (kidney 14 ppb in males and 15 ppb in females).<br />

Chromium<br />

No measurable effect on chromium content of liver and kidney<br />

at any dose level and exposure duration.<br />

Test condition:<br />

AUTHORS CONCLUSION<br />

The bioavailable traces of metals are considered to have no<br />

toxicological significance.<br />

EXPERIMENTAL DESIGN<br />

15 animals per dose per gender for toxicological<br />

investigations and 30 animals per gender in the control<br />

group;<br />

additionally 10 animals per dose and gender for analytical<br />

investigations and 20 animals per gender in the control<br />

group.<br />

Tests started at the age of 4- 5 weeks; TS given in powdered<br />

food (Altromin); feed and tape water ad libitum.<br />

General observations:<br />

Rats observed daily; food consumption and body weight gain<br />

determined once per week.<br />

UNEP PUBLICATIONS 31


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Haematological, clinical and biochemical investigations:<br />

RBC, reticulocytes, platelets, haemoglobin, haematocrit,<br />

total and differential WBC, MCV, ALP, GOT, GPT, creatinine,<br />

urea, glucose, cholesterol, total plasma proteins and urine<br />

proteins, urinalysis conducted after one month and at the<br />

end of the study on 5 males and 5 females of each group; in<br />

addition thromboplastin time and glutamate dehydrogenase<br />

activity measured after three months.<br />

Gross and histopathological investigations:<br />

organ weight determined for thyroid gland, thymus, heart,<br />

lung, liver, spleen, kidneys, adrenal glands, and gonads and<br />

histopathology performed together with aorta, eyes,<br />

intestine, femur, brain, urinary bladder, pituitary,<br />

cervical lymph nodes, stomach, oesophagus, epididymides,<br />

pancreas, prostate, seminal vesicle, bone marrow of sternum,<br />

trachea, uterus, skeletal muscles from 5 animals per gender<br />

of control and top dose group.<br />

Statistics:<br />

Data on weight determinations, hematology and clinical<br />

chemistry compared by Wilcoxon U-test, level of significance<br />

p 10000 mg/kg bw<br />

Method:<br />

other: no data<br />

GLP:<br />

no<br />

Test substance: as prescribed by 1.1 - 1.4<br />

Reliability: (4) not assignable<br />

secondary literature<br />

25-NOV-2004 (20)<br />

Type:<br />

LD50<br />

32<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Species:<br />

rat<br />

Strain:<br />

Sprague-Dawley<br />

Sex:<br />

male/female<br />

No. of Animals: 10<br />

Vehicle:<br />

other: see freetext<br />

Value:<br />

> 10000 mg/kg bw<br />

Method: other: comparable to OECD guideline 401<br />

GLP:<br />

no<br />

Result:<br />

MORTALITY:<br />

- No mortality<br />

CLINICAL SIGNS:<br />

- No symptoms of poisoning; body weight gain comparable to<br />

historical controls<br />

NECROPSY FINDINGS:<br />

- No macroscopical effects, no data on organs examined<br />

Test condition: TEST CONDITION<br />

- Day-night rhythm: 12:12h<br />

- Temperature: 22 +-1 °C<br />

- Rel. humidity: 55 +-10%<br />

- food and water ad libitum, withdrawal 16 h before<br />

application<br />

ADMINISTRATION:<br />

- Suspension prepared in 0.5% carboxymethyl cellulose prior<br />

to application, stirred during application period<br />

- Doses: one dose, 10000 mg/kg bw, gavage<br />

- Volume administered: 31.6 ml/kg bw<br />

- Post exposure observation period: 14 d<br />

EXAMINATIONS:<br />

- body weight measured prior to application and 7 and 14 d<br />

after dosing<br />

- clinical symptoms determined 15, 30 min and 1, 2, 4, 5 and<br />

<strong>24</strong> h after application, then daily<br />

- rats sacrificed on day 14, autopsy performed<br />

Test substance: C.I. pigment brown <strong>24</strong>, characterized as TiO2 79,9 %, Sb2O5<br />

13,4 %, Cr2O3 5,2 %, SiO2 1,5 %<br />

(crosscontamination with material from ball mill)<br />

As 40 ppm, Pb 140 ppm, Cu 7 ppm, Zn 40 ppm, Ni 2 ppm<br />

Reliability: (2) valid with restrictions<br />

Flag:<br />

Critical study for SIDS endpoint<br />

26-NOV-2004 (21)<br />

5.1.2 Acute Inhalation Toxicity<br />

Type:<br />

other: Inhalation Risk Test<br />

Species:<br />

rat<br />

Strain:<br />

no data<br />

Sex:<br />

no data<br />

No. of Animals: 12<br />

Vehicle:<br />

other: air<br />

Exposure time: 7 hour(s)<br />

Method: other: according to Smyth, H.F. et al., Am. Ind. Hyg. Ass. J.<br />

23, 95-107 (1962)<br />

Year: 1962<br />

GLP:<br />

no<br />

Result:<br />

No mortality during the exposure period, no symptoms of<br />

poisoning; autopsy revealed no macroscopical effects.<br />

UNEP PUBLICATIONS 33


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Test substance: C.I. pigment brown <strong>24</strong>, characterized as TiO2 79,9 %, Sb2O5<br />

13,4 %, Cr2O3 5,2 %, SiO2 1,5 %<br />

(crosscontamination with material from ball mill)<br />

As 40 ppm, Pb 140 ppm, Cu 7 ppm, Zn 40 ppm, Ni 2 ppm<br />

Test condition: For enrichment of the atmosphere 200 l air per h conducted<br />

through a layer of the product (height 5 cm); test at room<br />

temperature. Rats sacrificed.<br />

Reliability: (3) invalid<br />

unsuitable test system<br />

26-NOV-2004 (21)<br />

5.1.3 Acute Dermal Toxicity<br />

5.1.4 Acute Toxicity, other Routes<br />

5.2 Corrosiveness and Irritation<br />

5.2.1 Skin Irritation<br />

Species:<br />

rabbit<br />

Concentration: 50 %<br />

Exposure:<br />

Occlusive<br />

No. of Animals: 6<br />

Vehicle:<br />

water<br />

Result:<br />

slightly irritating<br />

Method: other: according to Federal Register 38, No. 187, § 1500.41,<br />

S. 27019, 27. Sept. 1973<br />

Year: 1973<br />

GLP:<br />

no<br />

Result:<br />

Intact skin:<br />

Evaluation of erythema after <strong>24</strong> and 72 hrs not possible due to<br />

treatment related staining of the skin (no histological<br />

examination of the epidermis in full thickness has been<br />

conducted, thus conclusion of dermal penetration of the test<br />

substance cannot be drawn from this study. In another study,<br />

however, it was reported that the staining of the skin could<br />

be removed by washing with soap, thereby corroberating that<br />

the staining was only superficial; ref. Bayer AG, basic data<br />

set, unpublished 20th Feb. 1997); no erythema after 8 d.<br />

Slight edema in 3/6 animals after <strong>24</strong> h, no edema after 72 h<br />

or 8 d.<br />

Abraded skin:<br />

Evaluation of erythema impossible after <strong>24</strong> and 72 h due to<br />

colouring of skin, no erythema after 8 d but scaling in 3/6<br />

rabbits.<br />

Edema in 4/6 rabbits after <strong>24</strong> h, no edema after 72 h or 8 d.<br />

Overall primary skin irritation value: 0.58<br />

slightly irritating<br />

Test condition: Application of 50% TS in water, Effects recorded after <strong>24</strong><br />

and 72 h and 8 d.<br />

Test substance: C.I. pigment brown <strong>24</strong>, characterized as TiO2 79,9 %, Sb2O5<br />

13,4 %, Cr2O3 5,2 %, SiO2 1,5 %<br />

(crosscontamination with material from ball mill)<br />

34<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

As 40 ppm, Pb 140 ppm, Cu 7 ppm, Zn 40 ppm, Ni 2 ppm<br />

Reliability: (2) valid with restrictions<br />

Flag:<br />

Critical study for SIDS endpoint<br />

26-NOV-2004 (21)<br />

Species:<br />

Result:<br />

Method:<br />

GLP:<br />

Test substance:<br />

rabbit<br />

not irritating<br />

other<br />

no<br />

other TS: not specified<br />

Remark:<br />

2 animals, 500 mg/animal, exposure period <strong>24</strong>h, postexposure<br />

period 7d<br />

Reliability: (4) not assignable<br />

Secondary literature<br />

14-MAR-2003 (22)<br />

5.2.2 Eye Irritation<br />

Species:<br />

rabbit<br />

Concentration: undiluted<br />

No. of Animals: 6<br />

Result:<br />

slightly irritating<br />

Method: other: according to Federal Register 38, No. 187, § 1500.42,<br />

S. 27019, 27. Sept. 1973<br />

Year: 1973<br />

GLP:<br />

no<br />

Result:<br />

No effects on cornea and iris.<br />

After <strong>24</strong> hrs clear reddening of conjunctivae in 1/6 rabbits,<br />

slight reddening in 5/6; slight secretion in 4/6 rabbits.<br />

After 48 hrs slight reddening of conjunctivae in 5/6 of<br />

animals; one rabbit without symptoms; slight secretion in 1/6<br />

rabbits.<br />

After 72 hrs three of six animals without symptoms; slight<br />

reddening of conjunctivae in 3/6 rabbits, no secretion.<br />

No substance related staining has been observed.<br />

The result indicates a mechanically mediated slight,<br />

reversible irritation of the mucous membrane due to the<br />

instillation of test substance particles into the eyes.<br />

Test condition: Readings after <strong>24</strong>, 48, 72 h.<br />

Test substance:<br />

C.I. pigment brown <strong>24</strong>, characterized as TiO2 79,9 %, Sb2O5<br />

13,4 %, Cr2O3 5,2 %, SiO2 1,5 %<br />

(crosscontamination with material from ball mill)<br />

As 40 ppm, Pb 140 ppm, Cu 7 ppm, Zn 40 ppm, Ni 2 ppm<br />

Reliability: (1) valid without restriction<br />

comparable to guideline study<br />

Flag:<br />

Critical study for SIDS endpoint<br />

26-NOV-2004 (21)<br />

Species:<br />

Result:<br />

Method:<br />

GLP:<br />

Test substance:<br />

rabbit<br />

not irritating<br />

other<br />

no<br />

other TS: not specified<br />

UNEP PUBLICATIONS 35


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Remark:<br />

2 animals, 50 mg/animal, postexposure period 7d<br />

Reliability: (4) not assignable<br />

Secondary literature<br />

25-OCT-2001 (22)<br />

5.3 Sensitization<br />

5.4 Repeated Dose Toxicity<br />

Species: rat Sex: male/female<br />

Strain:<br />

other: Wistar TNO W74<br />

Route of administration: oral feed<br />

Exposure period:<br />

<strong>90</strong> days<br />

Frequency of treatment: daily ad libitum<br />

Post exposure period: no<br />

Doses:<br />

10, 100, 1000, 10000 mg/kg diet (0.5, 5, 50, 500 mg/kg<br />

bw/day)<br />

Control Group:<br />

yes, concurrent vehicle<br />

NOAEL:<br />

= 500 mg/kg bw<br />

Method: other:comparable to OECD guideline 408<br />

GLP:<br />

no data<br />

Test substance: other TS: technical grade chrome rutile yellow (C.I. pigment<br />

brown <strong>24</strong>); characterized on a molar base as (Ti0.94 Sb0.03<br />

Cr0.03)O2 and as 85% TiO2, 10% Sb2O5, 5% Cr2O3 on weight%<br />

base<br />

Remark:<br />

Result:<br />

The detected traces of antimony (see results) most likely<br />

originate from the acid-soluble impurities of the pigment<br />

(10-20 mg antimony/kg pigment, that is 5-10 microgram/kg bw or<br />

125-250 microgram/kg organ weight at the highest dose) and<br />

therefore do not indicate bioavailability of the pigment<br />

itself.<br />

TOXICICITY<br />

No deaths, no overt signs of reactions to the treatment, no<br />

effects on body weight gain (similar food consumption in all<br />

groups) or organ weight, no treatment related findings<br />

from haematological or biochemical investigations and<br />

urinalysis.<br />

No macroscopic pathological changes attributable to<br />

treatment. No treatment related effects observed in<br />

histopathology.<br />

CHEMICAL ANALYSIS<br />

Antimony<br />

In males and females the Sb concentrations in liver and<br />

kidney were below the detection limit at doses up to 1000<br />

ppm. In the high dose groups the Sb levels slightly<br />

increased with exposure duration and reached max. 27 ppb in<br />

the liver (3 months) of males (range 15-40 ppb) and 17 ppb in<br />

females (kidney 14 ppb in males and 15 ppb in females).<br />

Chromium<br />

No measurable effect on chromium content of liver and kidney<br />

at any dose level and exposure duration.<br />

Test condition:<br />

36<br />

AUTHORS CONCLUSION<br />

The bioavailable traces of metals are considered to have no<br />

toxicological significance.<br />

EXPERIMENTAL DESIGN<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

15 animals per dose per gender for toxicological<br />

investigations and 30 animals per gender in the control<br />

group;<br />

additionally 10 animals per dose and gender for analytical<br />

investigations and 20 animals per gender in the control<br />

group.<br />

Tests started at the age of 4- 5 weeks; TS given in powdered<br />

food (Altromin); feed and tap water ad libitum.<br />

General observations:<br />

Rats observed daily; food consumption and body weight gain<br />

determined once per week.<br />

Haematological, clinical and biochemical investigations:<br />

RBC, reticulocytes, platelets, haemoglobin, haematocrit,<br />

total and differential WBC, MCV, ALP, GOT, GPT, creatinine,<br />

urea, glucose, cholesterol, total plasma proteins and urine<br />

proteins, urinalysis conducted after one month and at the<br />

end of the study on 5 males and 5 females of each group; in<br />

addition thromboplastin time and glutamate dehydrogenase<br />

activity measured after three months.<br />

Gross and histopathological investigations:<br />

organ weight determined from thyroid gland, thymus, heart,<br />

lung, liver, spleen, kidneys, adrenal glands, and gonads and<br />

histopathology performed together with aorta, eyes,<br />

intestine, femur, brain, urinary bladder, pituitary,<br />

cervical lymph nodes, stomach, oesophagus, epididymides,<br />

pancreas, prostate, seminal vesicle, bone marrow of sternum,<br />

trachea, uterus, skeletal muscles from 5 animals per gender<br />

of control and top dose group.<br />

Statistics:<br />

Data on weight determinations, hematology and clinical<br />

chemistry compared by Wilcoxon U-test, level of significance<br />

p= 5000 ug/plate<br />

Metabolic activation: with and without<br />

Result:<br />

negative<br />

Method:<br />

other: according to Ames<br />

GLP:<br />

yes<br />

Test substance: other TS: C.I. <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> 96.5 %<br />

Reliability: (4) not assignable<br />

secondary literature<br />

14-MAR-2003 (23)<br />

UNEP PUBLICATIONS 37


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Type:<br />

Mouse lymphoma assay<br />

System of testing: L5178Y mouse lymphoma cells, heterozygous at the TK<br />

locus<br />

Concentration:<br />

3.13, 6.25, 12.5, 25, 50, 100 µg/ml<br />

Cytotoxic Concentration: no cytotoxicity at any concentration tested (see also<br />

solubility in freetext)<br />

Metabolic activation: with and without<br />

Result:<br />

negative<br />

Method: other: Clive et al., Mutat. Res. 189, 143-156 (1987)<br />

Year: 1987<br />

GLP:<br />

yes<br />

Test substance: other TS: Chrome Antimony Titanate, no further details<br />

Method: Test comparable to OECD guideline 476<br />

Result:<br />

With metabolic activation (MA):<br />

Trial 1 not acceptable because of cell culture problems, but<br />

no mutagenicity was observed; in trial 2 no significant<br />

increase<br />

in mutant frequency (minimum criterion: 2-fold vehicle<br />

control) and no dose-related response, no cytotoxicity<br />

(relative growths 78.2% to 116.9%).<br />

Without MA:<br />

Trial 1 is not acceptable because of cell culture problems<br />

but no mutagenicity of the TS was detected; in trial 2 no<br />

cytotoxicity of TS (71.2-92.8% relative growths), but no<br />

treatment induced mutant frequency that exceeded minimum<br />

criterion and no dose related trend was observed.<br />

Valid positive controls with and without MA; mutant<br />

frequency in controls within acceptable range as well as<br />

acceptable cloning efficiencies (without MA 87.7% and with<br />

MA 100.3%)<br />

Test condition:<br />

AUTHORS EVALUATION<br />

TS was negative with and without activation under the<br />

conditions of testing; there was no cytotoxicity; the TS was<br />

insoluble and was tested at concentrations where it was<br />

possible to remove the TS at the end of exposure period.<br />

METABOLIC ACTIVATION (MA) SYSTEM<br />

S-9 mix with liver homogenate from male Sprague-Dawley rats<br />

treated with 500 mg/kg Aroclor1254 5 d prior to sacrifice<br />

CONTROLS<br />

Untreated (negative) control (only in cytotoxicity test) and<br />

vehicle control (DMSO); positive control methyl<br />

methanesulfate (without MA) and methylcholanthrene (with MA)<br />

MEDIA<br />

- culture medium: RPMI 1640 supplemented with PluronicF68,<br />

L-glutamine, sodium pyrovate, antibiotics and 10% horse<br />

serum<br />

- treatment medium: Fischers medium with same supplements<br />

but 5% horse serum<br />

- cloning medium: like culture medium but 20% horse serum<br />

and without PluronicF68 and addition of BBL purified agar<br />

(0.<strong>24</strong>%)<br />

- selection medium: cloning medium containing 3 µg/ml of TFT<br />

(5-trifluorothymidine)<br />

38<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

PERFORMANCE OF TEST<br />

TS formed a suspension in DMSO at concentrations from 0.195<br />

to 100 mg/l; higher concentrations are not included because of<br />

the insolubility of the TS (visible precipitates could not<br />

be removed by washing and dosing period could therefore not<br />

be controlled); in preliminary rangefinding tests no<br />

cytotoxicity at 1000 µg/ml; 2 independent trials; 3 vehicle<br />

controls and 2 positive controls in each trial; exposure<br />

period 4 h; expression period 2 d; selection period 10-14 d.<br />

Since the TS was negative, colony sizing was not performed<br />

(total mutant colonies documented).<br />

Reliability: (2) valid with restrictions<br />

Flag:<br />

Critical study for SIDS endpoint<br />

14-MAR-2003 (<strong>24</strong>)<br />

Type:<br />

Ames test<br />

System of testing: Salmonella typhimurium TA98, 100, 1535, 1537, 1538<br />

Concentration:<br />

100, 250, 500, 1000, 2500, 5000 µg/plate<br />

Cytotoxic Concentration: no cytotoxicity at any concentration/exp. design<br />

(compare with solubility/precipitates, see freetext)<br />

Metabolic activation: with and without<br />

Result:<br />

negative<br />

Method: other: Maron and Ames, Mutat. Res. 113, 173-215 (1983)<br />

Year: 1983<br />

GLP:<br />

yes<br />

Test substance: other TS: Chrome Antimony Titanate, LOT no.: CP653-1 (Color<br />

<strong>Pigment</strong>s Manufactures Assoc.), no further data<br />

Method: Comparable with OECD guideline 471<br />

Result: In preliminary dose range-finding studies (TA100, 6.8-5000<br />

µg/plate, 10 doses) no cytotoxicity with and without S9-mix;<br />

precipitates at 1000 µg/plate (background lawn could not be<br />

evaluated).<br />

GENOTOXIC EFFECTS:<br />

- With and without metabolic activation: no positive results<br />

at any dose level in all tested strains.<br />

-CYTOTOXIC CONCENTRATION:<br />

- No cytotoxicity of the TS at any dose level; precipitates<br />

at 1000 µg/plate.<br />

CONTROLS:<br />

spontaneous revertants in negative controls within the<br />

normal range; valid positive controls.<br />

Test condition:<br />

Evaluation:<br />

Under the condition of this study the TS did not cause an<br />

increase in the number of revertants of any tester strain<br />

either with or without metabolic activation.<br />

SYSTEM OF TESTING<br />

- Type: plate incorporation method<br />

- Metabolic activation system: S9-mix, liver microsomes<br />

prepared from male Sprague-Dawley rats i.p. injected with<br />

500 mg/kg Aroclor1254.<br />

- number of plates per concentration/control: 3<br />

- Solvent: DMSO, insoluble TS formed suspension which<br />

remained in all dilutions<br />

- Controls: negative (vehicle control and sterility control)<br />

and positive control:<br />

-S9 mix: 2-nitrofluorene (TA98, TA1538), sodium azide (TA1535,<br />

TA100), ICR-191 (TA1537)<br />

UNEP PUBLICATIONS 39


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

+S9 mix: 2-Aminoanthracene (five strains)<br />

- Cytotoxicity: evaluated via bacterial background lawn and<br />

reduction in revertant colonies<br />

CRITERIA FOR EVALUATING RESULTS:<br />

TA98 and TA100 considered positive if the TS produced at<br />

least a 2-fold increase in revertants per plate over vehicle<br />

control and a dose response to increasing concentrations;<br />

same criteria for the other strains but 3-fold increase.<br />

Reliability: (2) valid with restrictions<br />

No 2nd independent trial<br />

Flag:<br />

Critical study for SIDS endpoint<br />

14-MAR-2003 (25)<br />

Type:<br />

Micronucleus test in vitro<br />

System of testing: V79 Chinese Hamster Lung Cells<br />

Concentration:<br />

0.78-25 µg/ml (see freetext for further details)<br />

Cytotoxic Concentration: no cytotoxic response under any exp. condition<br />

Metabolic activation: with and without<br />

Result:<br />

negative<br />

Method:<br />

other: see freetext<br />

GLP:<br />

yes<br />

Test substance: other TS: <strong>Pigment</strong> <strong>Brown</strong> <strong>24</strong> obtained from BASF AG, purity 99.4%<br />

Method:<br />

Result:<br />

Test according to a proposal for a new OECD guideline for<br />

the in vitro micronucleus test (1998).<br />

Literature:<br />

Kallweit et al., 1999, Mut Res 439, 183-199<br />

Seelbach et al., 1993, Mut Res 303, 163-169<br />

Seelbach et al., 1993, Toxicol in vitro, 7, 185-193<br />

TS precipitation in the vehicle observed at all test doses,<br />

in culture "obviously soluble up to 6.25 µg/ml". Osmolality<br />

and pH values not influenced by the treatment.<br />

GENOTOXIC EFFECTS:<br />

With and without metabolic activation in both trials no<br />

increase in the number of micronuclei at any dose level.<br />

CYTOTOXIC CONCENTRATION:<br />

No suppression of the mitotic activity at any dose level<br />

(determination of mitotic index); determination of the<br />

proliferation index (allows measurement of colony size)<br />

revealed no cytotoxic response under any exp. condition as<br />

well as the cell counts showed no growth inhibition; cell<br />

attachment was not influenced at any dose.<br />

CONTROLS:<br />

Spontaneous micronuclei in negative controls within the<br />

normal range; valid positive controls.<br />

Test condition:<br />

EVALUATION:<br />

Under the condition of this study the TS did not cause an<br />

increase in the number of micronuclei of the tester strain<br />

either with or without metabolic activation. TS considered<br />

not to induce clastogenic or aneugenic effects.<br />

METABOLIC ACTIVATION (MA) SYSTEM<br />

S-9 mix with liver homogenate from male Sprague-Dawley rats<br />

treated with 500 mg/kg Aroclor1254 5 d prior to sacrifice<br />

CONTROLS<br />

40<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

concurrent vehicle controls (DMSO); concurrent positive<br />

controls ethyl methanesulfonate (without MA) and<br />

cyclophosphamide (with MA)<br />

MEDIA<br />

- culture medium: MEM medium with 10% fetal calf serum & 2%<br />

antibiotics<br />

- treatment medium: same medium without fetal calf serum<br />

PERFORMANCE OF TEST<br />

DMSO used as vehicle. Max. doses in the different exp.<br />

designs 12.5-25 µg/ml; higher doses could not be evaluated<br />

due to TS precipitation which interfered with evaluation of<br />

cells (determined in pretests).<br />

In all exp. groups duplicate cultures used; 1000 cells per<br />

culture analysed;<br />

1st Trial (mixed population mehod):<br />

a) <strong>24</strong> h exposure, <strong>24</strong> h harvest time, without S9-mix<br />

b) 4 h exposure, <strong>24</strong> h harvest time, with S9-mix<br />

concentrations in a) and b): 0, 1.25, 2.5, 5, 10, 15 µg/ml<br />

2nd Trial using the mitotic shake off method (<strong>24</strong> h mitotic<br />

shake off):<br />

a) <strong>24</strong> h exposure, 27 h preparation time, without S9-mix;<br />

concentrations 0, 0.78, 1.56, 3.12, 6.25, 12.5 µg/ml<br />

b) 4 h exposure, 27 h preparation time, with S9-mix;<br />

concentrations 0, 1.56, 3.12, 6.25, 12.5, 25 µg/ml<br />

STATISTICS<br />

No statistical analysis due to the clear negative findings.<br />

EVALUATION CRITERIA<br />

No significant increase in the number of micronulei at any<br />

dose level above concurrent negative control and within<br />

historical control data; number of micronuclei in concurrent<br />

negative control within the normal range; significant<br />

increase in number of micronuclei in positive controls.<br />

Test substance: Stability of the TS verified by reanalysis; homogeniety<br />

given.<br />

Reliability: (1) valid without restriction<br />

Flag:<br />

Critical study for SIDS endpoint<br />

14-MAR-2003 (26)<br />

Type:<br />

Bacterial reverse mutation assay<br />

System of testing: E. coli WP2uvrA<br />

Concentration:<br />

100, 250, 500, 1000, 2500, 5000 µg/plate<br />

Cytotoxic Concentration: no cytotoxicity at any concentration/exp. design<br />

(compare with solubility/precipitates, see freetext)<br />

Metabolic activation: with and without<br />

Result:<br />

negative<br />

Method: other: comparable to OECD guideline 472<br />

GLP:<br />

yes<br />

Test substance: other TS: Chrome Antimony Titanate, LOT no.: CP653-1 (Color<br />

<strong>Pigment</strong>s Manufactures Assoc.), no further data<br />

Result:<br />

In preliminary dose range-finding study (6.7-5000 µg/plate,<br />

10 doses) no cytotoxicity with and without S9-mix;<br />

precipitates at 1000 µg/plate (background lawn could not be<br />

evaluated).<br />

UNEP PUBLICATIONS 41


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

GENOTOXIC EFFECTS:<br />

- With and without metabolic activation: no positive results<br />

at any dose level.<br />

-CYTOTOXIC CONCENTRATION:<br />

- No cytotoxicity of the TS at any dose level; precipitates<br />

at 1000 µg/plate.<br />

CONTROLS:<br />

spontaneous revertants in negative controls within the<br />

normal range; valid positive controls.<br />

Test condition:<br />

Evaluation:<br />

Under the condition of this study the TS did not cause an<br />

increase in the number of revertants of the tester strain<br />

either with or without metabolic activation.<br />

SYSTEM OF TESTING<br />

- Type: plate incorporation method<br />

- Metabolic activation system: S9-mix, liver microsomes<br />

prepared from male Sprague-Dawley rats i.p. injected with<br />

500 mg/kg Aroclor1254.<br />

- number of plates per concentration/control: 3<br />

- Solvent: DMSO, insoluble TS formed suspension which<br />

remained in all dilutions<br />

- Controls: negative (vehicle control and sterility control)<br />

and positive control with (2-aminoanthracene) and without<br />

S9-mix (4-nitroquinoline-N-oxide).<br />

- Cytotoxicity: evaluated via bacterial background lawn and<br />

reduction in revertant colonies<br />

CRITERIA FOR EVALUATING RESULTS:<br />

Considered positive if the TS produced at least a 2-fold<br />

increase in revertants per plate over vehicle control and a<br />

dose response to increasing concentrations.<br />

Reliability: (2) valid with restrictions<br />

No 2nd independent trial<br />

Flag:<br />

Critical study for SIDS endpoint<br />

15-OCT-2001 (25)<br />

5.6 Genetic Toxicity 'in Vivo'<br />

5.7 Carcinogenicity<br />

5.8.1 Toxicity to Fertility<br />

Type:<br />

other: repeated dose toxicity<br />

Species:<br />

rat<br />

Sex:<br />

male/female<br />

Strain:<br />

other: Wistar TNO W74<br />

Route of administration: oral feed<br />

Exposure Period:<br />

<strong>90</strong> days<br />

Frequency of treatment: daily ad libitum<br />

Doses: 10, 100, 1000, 10000 mg/kg diet (0.5, 5, 50, 500<br />

mg/kg bw/day)<br />

Method: other:comparable to OECD guideline 408<br />

GLP:<br />

no data<br />

Test substance: other TS: technical grade chrome rutile yellow (C.I. pigment<br />

brown <strong>24</strong>); characterized on a molar base as (Ti0.94 Sb0.03<br />

Cr0.03)O2 and as 85% TiO2, 10% Sb2O5, 5% Cr2O3 on weight%<br />

42<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

TOXICITY ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

base<br />

Result:<br />

no effects on organ weights and macro-and micro-histopathology<br />

of gonads (testes, epididymides, prostate, seminal vesicle,<br />

ovary and uterus) were observed in the <strong>90</strong> day feeding study on<br />

rats at doses up to 500 mg/kg bw/ day<br />

Reliability: (2) valid with restrictions<br />

Flag:<br />

Critical study for SIDS endpoint<br />

14-MAR-2003 (19)<br />

5.8.2 Developmental Toxicity/Teratogenicity<br />

5.8.3 Toxicity to Reproduction, Other Studies<br />

5.9 Specific Investigations<br />

5.10 Exposure Experience<br />

Remark:<br />

<strong>24</strong>-AUG-2001<br />

no data available<br />

5.11 Additional Remarks<br />

Type:<br />

other: update info<br />

Remark: no relevant new data located, 16. March 1998<br />

16-MAR-1998<br />

UNEP PUBLICATIONS 43


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

ANALYT. METH. FOR DETECTION AND IDENTIFICATION ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

6.1 Analytical Methods<br />

6.2 Detection and Identification<br />

44<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

EFFECTS AGAINST TARGET ORG. AND INTENDED USES ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

7.1 Function<br />

7.2 Effects on Organisms to be Controlled<br />

7.3 Organisms to be Protected<br />

7.4 User<br />

7.5 Resistance<br />

UNEP PUBLICATIONS 45


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

MEAS. NEC. TO PROT. MAN, ANIMALS, ENVIRONMENT ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

8.1 Methods Handling and Storing<br />

Safe Handling: Breathing must be protected when large quantities are decanted<br />

without local exhaust ventilation.<br />

Fire/Exp. Prot.: Avoid dust formation.<br />

Storage Req.: Keep container tightly closed.<br />

Transport Code: Not classified as hazardous under transport regulations.<br />

Remark:<br />

Personal protective equipment<br />

Respiratory protection:<br />

Suitable respiratory protection for higher concentrations or<br />

long-term effect: Particle filter EN 143 Type P1, low<br />

efficiency, (solid particles of inert substances).<br />

Hand protection:<br />

Chemical resistant protective gloves (EN 374) e.g. nitrile<br />

rubber (0.4 mm(, chloroprene rubber (0.5 mm),<br />

polyvinylchloride (0.7 mm) and other.<br />

Manufacturer's directions for use must be observed because of<br />

great diversity of types.<br />

Eye protection:<br />

Safety glases with side-sgields (frame goggles) (EN 166)<br />

General safety and hygiene measures:<br />

Handle in accordance with good industrial hygiene and safety<br />

practice. Due to the coloring properties of the product closed<br />

work clothes should be used, to avoid stains during<br />

manipulation. Hands and/or face should be washed before breaks<br />

and at the end of the shift.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

8.2 Fire Guidance<br />

Hazards:<br />

Evolution of fumes/fog. Harmful vapours can be released in<br />

case of fire.<br />

Prot. Equipment: Wear a self-contained breathing-apparatus.<br />

Ext. Medium: water spray, dry extinguishing media, foam, carbon dioxide<br />

Add. Information: The degree of risk is governed by the burning substance and<br />

the fire conditions. Contaminated extinguishing water must be<br />

disposed of in accordance with official regulations.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

8.3 Emergency Measures<br />

Type:<br />

other: general advice<br />

Remark:<br />

Remove contaminated clothing.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

Type:<br />

Remark:<br />

46<br />

injury to persons (skin)<br />

Wash thoroughly with soap and water.<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

MEAS. NEC. TO PROT. MAN, ANIMALS, ENVIRONMENT ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

Type:<br />

injury to persons (eye)<br />

Remark:<br />

Wash affected eyes for at least 15 minutes under running water<br />

with eyelids held open.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

Type:<br />

injury to persons (oral)<br />

Remark:<br />

Rinse mouth and then drink plenty od water.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

Type:<br />

injury to persons (inhalation)<br />

Remark:<br />

If difficulties occur after dust has been inhaled, remove to<br />

fresh air and seek medical attention.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

Type:<br />

other: Note to physician<br />

Remark:<br />

If difficulties occur after dust has been inhaled, remove to<br />

fresh air and seek medical attention.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

Type:<br />

Remark:<br />

accidental spillage<br />

Personal precautions:<br />

Avoid dust formation. Use personal protective clothing.<br />

Environmental precautions:<br />

Contain contaminated water/firefighting water. Do not<br />

discharge into drains/surface water/groundwater.<br />

Methods for cleaning up or taking up:<br />

For small amounts: Pick up with suitable appliance and dispose<br />

of.<br />

For large amounts: Contain with dust binding material and<br />

dispose of.<br />

Avoid raising dust.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

8.4 Possib. of Rendering Subst. Harmless<br />

8.5 Waste Management<br />

Memo:<br />

other: must be dumped or incinerated in accordance with local<br />

regulations.<br />

Flag:<br />

non confidential, Critical study for SIDS endpoint<br />

15-NOV-2002 (1)<br />

UNEP PUBLICATIONS 47


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

MEAS. NEC. TO PROT. MAN, ANIMALS, ENVIRONMENT ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

8.6 Side-effects Detection<br />

8.7 Substance Registered as Dangerous for Ground Water<br />

8.8 Reactivity Towards Container Material<br />

48<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

REFERENCES ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

(1) BASF AG, Safety data sheet SICOTAN GELB L 1910, 04.07.2002<br />

(30047688)<br />

(2) H.Endriß, Inorganic coloured pigments today, Curt R.<br />

Vincentz Verlag, Hannover, 1998<br />

(3) personal communication, Dr. Hartmut Endriss, BASF AG,<br />

11/2002<br />

(4) MAK- und BAT-Werte-Liste 2002 (Mitteilung 38 vom<br />

01.07.2002), WILEY-VCH Verlag GmbH, Weinheim, Germany<br />

(5) Catalogue of Substances Hazardous to Water - Umweltbundesamt<br />

Berlin, status 11.11.2002<br />

(6) National Chemical Inventories 2001 Issue 1<br />

(7) BASF AG, Safety data sheet Sicotan Gelb L 2011, 02.10.2000<br />

(8) BASF AG, expert judgement, 2002<br />

(9) BASF AG, personal communication, 12.08.2002<br />

(10) BASF AG, Umweltanalytik, Mitteilung vom <strong>24</strong>.03.95<br />

(11) Bayer AG, Safety data sheet, cited in BAYER base data set<br />

(12) BASF AG, Department of Toxicology, unpublished data, Project<br />

No. 10F0066/885110, 25.10.1988<br />

(13) BASF AG, department of ecology, unpublished data<br />

(Project No. 99/0484/50/1), 17.01.2000<br />

(14) BASF AG, department of ecology, unpublished data (Report No.<br />

99/0484/60/1), 04.05.2000<br />

(15) Safety Data Sheet Bayer AG (zitiert nach EUCLID Data Sheet<br />

vom 18.08.1994, Bayer AG)<br />

(16) BASF AG, Dep. Ecology, unpublished data, Datenerhebung für<br />

oekotoxikologische Untersuchungen vom 18.1.1988<br />

(17) BASF AG, Dep. Ecology, unpublished data, Project No.<br />

01/88/0121, 02.01.1997<br />

(18) BASF AG, Mitteilung vom 20.03.95<br />

(19) Bomhard E. et al. (1982), Toxicol. Lett. 14, 189-194<br />

(20) Bayer AG, unpublished data, 23.11.1972, cited in Bayer base<br />

data set, last update 19.08.1994<br />

(21) BASF AG, Department of Toxicology, unpublished data,<br />

substance 77/146, 28.03.1978<br />

(22) Bayer AG, unpublished data, 29.03.1979, cited in Bayer base<br />

data set, last update 18.08.1994<br />

(23) Bayer AG, unpublished data, Report No. 19<strong>90</strong>9, Jan. 1991,<br />

cited in Bayer base data set, last update 18.08.1994<br />

UNEP PUBLICATIONS 49


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

REFERENCES ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

(<strong>24</strong>) Corning Hazelton, CHV STUDY No. 16595-0-431, Apr. 1996,<br />

sponsored by Color <strong>Pigment</strong>s Manufacturers Association<br />

(25) Corning Hazelton, CHV Study No. 16595-0-409, June 1995,<br />

sponsored by Color <strong>Pigment</strong>s Manufacturers Association<br />

(26) BASF Aktiengesellschaft, Product Safety, unpublished data,<br />

Report No.: 33M0278/994093 (2001)<br />

50<br />

UNEP PUBLICATIONS


OECD SIDS C.I. PIGMENT BROWN <strong>24</strong><br />

SUMMARY AND EVALUATION ID <strong>68186</strong>-<strong>90</strong>-3<br />

DATE: 26-NOV-2004<br />

10.1 End Point Summary<br />

10.2 Hazard Summary<br />

10.3 Risk Assessment<br />

UNEP PUBLICATIONS 51

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