Registration Dossier
Registration Dossier
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EC number: 203-607-0 | CAS number: 108-69-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
OECD 371, with and without S9 mix, S. typhimurium TA1535, TA 1537, TA 98, TA 97 and TA 100: negative
OECD 473, with and without S9 mix, CHL/IU cells: weakly positive with metabolic activation
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Vehicle / solvent:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- + S9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- - S9 mix
- Species / strain:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- weekly positive with metabolic activation
3,5-Dimethylaniline induced structural chromosomal aberrations in CHL/IU cells at highest concentration (900µg/L) after 6 hr short-term treatment with and without exogenous metabolic activation. Polyploidy was not induced under the conditions of the present study. - Executive summary:
3,5-Dimethylaniline induced structural chromosomal aberrations in CHL/IU cells at highest concenttraion (900µg/L) after 6 hr short-term treatment with and without exogenous metabolic activation. Polyploidy was not induced under the conditions of the present study.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No details available.
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 97 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Hamster or RAT, LIVER, S-9, AROCLOR 1254 (10%)
- Vehicle / solvent:
- DMSO
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 97 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- negative
- Executive summary:
The test item was tested in an Mutagenicity reverse Mutation Assay according to OECD Guideline 371 in S. typhimurium TA1535, TA 1537, TA 98, TA 97 and TA 100 with and without metabolic actication (S9 mix). The substance was negative in the test.
Referenceopen allclose all
Test results:
Cytogenetic effects were seen as follows.
At the highest concentration (900 µg/ml) after 6 hr short-term treatment with and without exogenous metabolic activation, 22.5 and 12.0% cells demonstrated structural chromosomal aberrations including gaps.
Genotoxic effects: clastogenicity polyploidy
+ ? - + ? -
Without metabolic activation: [ ] [ ] [ * ] [ ] [ ] [ * ]
With metabolic activation: [ * ] [ ] [ ] [ ] [ ] [ * ]
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the in vitro tests on mutagenicity the test item is expected to be not mutagenic and classification according to Regulation (EC) No 1272/2008 will not be warranted based on in vitro tests. But as weakly postitive results were observed in the OECD 473 study, risk management measures of hazard band "medium" will be applied for safety precaution.
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