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EC number: 947-805-1 | CAS number: 213077-23-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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- Endpoint summary
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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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro bacterial gene mutation assay (Ames Test) (comparable to OECD 471)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- May 26, 1983
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): TK 12437 (Irgastab CH 302)
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from livers of Aroclor 1254 treated rats
- Test concentrations with justification for top dose:
- Preliminary Toxicity / Range-Finding Test (TA 100 and WP2): 20 to 5000 µg/plate.
Mutagenicity Test: Original experiment - 625 - 5000 µg/plate; Confirmatory experiment - 78 - 625 µg/plate. Doses in original experiment were chosen based on results of range-finding test. Because toxic effects occurred on the growth of revertant colonies in the original experiment with strain TA 100 (without and with activation) and with strain TA 1537 (with activation) the experiments with these strains were repeated with four concentrations in the ränge of 78.1 - 62 5 µg/plate - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- cyclophosphamide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: about 48 hours at 37 ± 1.5°C in darkness
NUMBER OF REPLICATIONS: two plates per test concentration
- Rationale for test conditions:
- per standard references, including OECD 471 test guideline
- Evaluation criteria:
- Assay acceptance criteria:
A test is considered acceptable if the mean colony counts of the control values of all strains are within the acceptable ranges and if the results of the positive controls meet the criteria for a positive response.
Criteria for a positive response:
The test substance is considered to be mutagenic in this test system if:
- A positive effect is observed in one strain and the effect can be reproduced in a confirmatory experiment.
- A positive effect is observed in two or more strains.
A positive effect is defined as an increase of the mean number of revertants per plate for any concentration above that of the negative control by at least a factor of 2,0 with strains TA 98, TA 1535, TA 1537 and WP2 uvrA, or by a factor of at least 1.5 with strain TA 100. Generally a concentration-related effect should be demonstrable. - Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- In a standard Ames Test, Irgastab CH 302 did not induce gene mutations in bacteria with our without metabolic activation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on the available data, Irgastab CH 302 is not classified for germ cell mutagenicity according to Regulation (EC) No 1272/2008.
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