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EC number: 269-052-1 | CAS number: 68186-90-3 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77310.
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
- Reference Type:
- secondary source
- Title:
- C.I. Pigment Brown 24
- Author:
- OECD
- Year:
- 2 002
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 15
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Proposal for OECD guideline 487
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Chrome antimony titanium buff rutile
- EC Number:
- 269-052-1
- EC Name:
- Chrome antimony titanium buff rutile
- Cas Number:
- 68186-90-3
- Molecular formula:
- (Ti, Sb, Cr) O2
- IUPAC Name:
- manganese(4+) trititanium(4+) pentaantimony(3+) chromium(3+) nickel(2+) octadecaoxidandiide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: Abl. Nr. 99-7135
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM medium with glutamine supplemented with 10% (v/v) fetal calf serum (FCS), 1 % (v/v) penicillin/streptomycin (10,000 IU/ 10,000 µg/mL) and 1 % (v/v) amphotericine B (250 µg/mL)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from 5 male Sprague-Dawley rats (200 - 300 g) which received a single i.p. injection of 500 mg Aroclor 1254 per kg body weight 5 days before sacrifice.
- Test concentrations with justification for top dose:
- Range-finding cytotoxicity tests:
Mixed Population Method
0.5, 10.0, 5.0, 10.0, 100.0, 250.0, 500.0, 750.0 and 900.0 µg/mL
Mitotic Shake Off Method
3.125, 6.250, 21.500, 25.000, 50 µg/mL
Main test:
Mixed Population Method
0.3125, 0.6250, 1.2500, 2.5000, 5.0000, 10.0000 and 15.0000 µg/mL (24 h exposure, 24 h harvest time, -/+S9)
Mitotic Shake Off Method
0.200, 0.390, 0.780, 1.560, 3.125, 6.250 and 12.500 µg/mL (24 h exposure, 27 h preparation time, -S9)
1.560, 3.125, 6.250, 12.500, 25.000, 50.000 and 75.000 µg/mL (4 hours exposure, 27 h preparation time, +S9) - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- with and without S-9 mix
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: - S9-mix: 350 µg Ethylmethanesulfonate (EMS); +S9-mix: 2.5 µg Cyclophosphamide (CPP); given quantities were added to 1 mL (Mixed Population Method) or 5 mL (Mitotic Shake Off Method).
- Details on test system and experimental conditions:
- MIXED POULATION METHOD & MITOTIC SHAKE OFF METHOD
(according to Kallweit et al. 1999 and Seelbach et al. 1993, respectively)
METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 6 hrs
- Exposure duration: without S9-mix 24 hrs; with S9-mix 4 hrs followed by a 20-hr period after replacing the S9-mix; treatment medium without fetal calf serum
- Fixation time (start of exposure up to fixation or harvest of cells): 24 hrs
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 2000
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index (MI)
A mitotic index based on 1,000 cells/culture was determined for all dose groups with and without S-9 mix both in the Mixed Population Method and Mitotic Shake Off Method
- Method: Proliferation Index (PI )
In addition to the evaluation of micronuclei and mitotic index in the Mixed Population Method, the proliferation index (PI) was determined as a measure of cytotoxicity. The PI, based on 1,000 cells per culture (2,000 cells per dose group), was determined for all test groups, with or without S-9 mix. The number of clones (packs) consisting of 1 cell, 2, 4 or 8 cells was recorded and the PI was calculated using the following formula:
PI = ((ncl-1) x 1 + (ncl-2) x 2 + (ncl-4) x 3 + (ncl-8) x 4)/total No . of clones; whereas
cl-1 = cell clone with 1 cell
cl-2 = cell clone with 2 cell s
cl-3 = cell clone with 3 or 4 cells
cl-4 = cell clone with 5, 6, 7 or 8 cells
OTHER
Cell morphology: About 3 - 4 hours after test substance treatment with S-9 mix and about 22 - 24 hours after treatment without S-9 mix, the cell morphology, which is an indication of attachment of the cells to the slides or flasks, was checked for each culture in all test groups using both modifications of the assays (with the exception of the positive controls) .
Fragmentation: During evaluation of 1,000 cells/culture the occurance of fragmentation (fragmented nuclei or multinucleated cells and cells with > 6 micronuclei) was recorded. - Evaluation criteria:
- Definition of micronucleus
- the micronucleus consists of an area less than 1/3 of the area of the main nucleus
- the micronucleus and main nucleus retain the same staining
- the micronucleus is not linked to the main nucleus and is located within the cytoplasm of the cell
- for evaluation, only cells clearly surrounded by a nuclear membrane were scored
Evaluation criteria
The test chemical is to be considered positive in this assay if the following criteria are met:
- A dose-related and reproducible significant increase in the number of cells containing micronuclei.
- The proportion of micronucleus-containing cells exceeded both the concurrent negative control range and the negative historical control range.
A test substance is generally considered nonclastogenic in this test system if there was no significant increase in the number of micronucleus-containing cells at any dose above concurrent negative control frequencies and within the historical control data. - Statistics:
- No statistical analysis due to the clear negative findings.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Precipitation: Strong test substance precipitation in the cultures was observed at all test doses.
Any other information on results incl. tables
MICRONUCLEUS FREQUENCY
Mixed population method |
|||||
Substance |
Dose (µg/mL) |
Exposure (h) |
Harvest (h) |
S-9 mix |
Frequency (%) |
vehicle |
solvent |
24 |
24 |
- |
0.65 |
solvent |
24 |
24 |
+ |
0.65 |
|
test substance |
1.25 |
24 |
24 |
- |
1.20 |
1.25 |
24 |
24 |
+ |
0.40 |
|
2.50 |
24 |
24 |
- |
0.60 |
|
2.50 |
24 |
24 |
+ |
0.70 |
|
5.00 |
24 |
24 |
- |
1.15 |
|
5.00 |
24 |
24 |
+ |
0.65 |
|
10.00 |
24 |
24 |
- |
0.75 |
|
10.00 |
24 |
24 |
+ |
0.65 |
|
15.00 |
24 |
24 |
- |
0.70 |
|
15.00 |
24 |
24 |
+ |
0.65 |
|
Positive ctrl |
EMS: 350 |
24 |
24 |
- |
2.60 |
CPP: 2.50 |
24 |
24 |
+ |
10.15 |
|
Mitotic shake off method |
|||||
Substance |
Dose (µg/mL) |
Exposure (h) |
Harvest (h) |
S-9 mix |
Frequency (%) |
vehicle |
solvent |
24 |
24 |
- |
0.55 |
solvent |
4 |
24 |
+ |
0.50 |
|
Test substance |
0.78 |
24 |
24 |
- |
0.60 |
1.56 |
4 |
24 |
+ |
0.35 |
|
1.56 |
24 |
24 |
- |
0.70 |
|
3.13 |
4 |
24 |
+ |
0.35 |
|
3.13 |
24 |
24 |
- |
0.20 |
|
6.25 |
4 |
24 |
+ |
0.45 |
|
6.25 |
24 |
24 |
- |
0.35 |
|
12.50 |
4 |
24 |
+ |
0.45 |
|
12.50 |
24 |
24 |
- |
0.25 |
|
25.00 |
4 |
24 |
+ |
0.20 |
|
Positive ctrl |
EMS: 350 |
24 |
24 |
- |
3.30 |
CPP: 2.50 |
4 |
24 |
+ |
4.45 |
MITOSIS
According to the results of the determination of the mitotic index, no suppression of the mitotic activity was observed under all experimental conditions.
CYTOTOXICITY (only Mixed Population Method)
According to the results of the determination of the PI, no cytotoxic response was observed under any of the experimental conditions.
CELL MORPHOLOGY
Cell attachment was not influenced at any dose evaluated for micronuclei.
PRECIPITATION
The test substance precipitation in the vehicle was observed at all test doses, in culture "obviously soluble up to 6.25 µg/mL”
Applicant's summary and conclusion
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