C.I. Pigment Brown 24 CAS N°: 68186-90-3
C.I. Pigment Brown 24 CAS N°: 68186-90-3
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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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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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 />
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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 />
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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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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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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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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 />
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(16) BASF AG, Dep. Ecology, unpublished data, Datenerhebung für<br />
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(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 />
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cited in Bayer base data set, last update 18.08.1994<br />
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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