Registration Dossier
Registration Dossier
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EC number: 209-502-6 | CAS number: 583-39-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vivo
Description of key information
Link to relevant study records
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A reliable publication, summarising derivative pharmaco-toxicological action, was used. However the substance of interest was not revisited in order to verify the contents; for this reason reliability score 2 was used.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- It is not specified.
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Route of administration:
- intraperitoneal
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- single treatment 40 mg/kg bw
- Remarks:
- Doses / Concentrations:
40 mg/kg bw DMBA(7,12-Dimethylbenz[·]anthracene)
Basis:
nominal conc.
four groups - Remarks:
- Doses / Concentrations:
50 mg/kg bw with test material
Basis:
nominal conc.
three of the four groups with test material - Remarks:
- Doses / Concentrations:
1 ml/kg bw of corn oil
Basis:
nominal conc.
fifth group - Remarks:
- Doses / Concentrations:
50 mg/kg bw of test material
Basis:
nominal conc.
sixth group - No. of animals per sex per dose:
- six groups of six
- Control animals:
- yes, concurrent vehicle
- Tissues and cell types examined:
- thymus, spleen, liver, kidney, lung, bone marrow and lymph nodes
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Interpretation of results (migrated information): negative
The data reported suggest that substance exhibited antimutagenic activity. The quality of information is scarce and the classification is inconclusive
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The data reported suggest that substance exhibited antimutagenic activity. The quality of information is scarce and the classification is inconclusive
Justification for classification or non-classification
The quality of information is scarce and the classification is inconclusive
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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