Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vivo
Administrative data
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across to related substance with same EC number (410-190-0) identified during Inquiry Process (Inquiry number: 06-0000021779-56-0000). Previous data (>12 yrs old) provided by ECHA.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Micronucleus study (See comments)
- GLP compliance:
- yes
- Type of assay:
- other: non-bacteriological test in vivo - 6th Amendment data
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- Neat substance
- No. of animals per sex per dose:
- Female: 0 mg/kg; no. of animals: Sacrifice times: hours
Female: 125 mg/kg; no. of animals: Sacrifice times: hours
Female: 500 mg/kg; no. of animals: Sacrifice times: hours
Female: 2000 mg/kg; no. of animals: Sacrifice times: hours
Results and discussion
Test results
- Toxicity:
- yes
- Remarks:
- (doses producing toxicity: P/N Ratio: No change was observed. Other Toxic signs: None)
- Additional information on results:
- Observations:
There was no increase in micronucleus formation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The in vivo chrommosome aberration test was negative for the surrogate substance EC 410-190-0.
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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