Registration Dossier
Registration Dossier
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EC number: 939-331-9 | CAS number: 1394155-71-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- : lack of details on test substance
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 68955-20-4 (purity 55%)
- IUPAC Name:
- 68955-20-4 (purity 55%)
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: No data
- Analytical purity: 55% a.i.
- Lot/batch No.: No data
- Storage condition of test material: No data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CFW 1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to guideline.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- 24 h (400, 2000, 4000 mg/kg bw)
48, 72 h (4000 mg/kg bw) - Frequency of treatment:
- Single
- Post exposure period:
- n.a.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
400, 2000, 4000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 7
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Yes.
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- SAMPLING TIMES:
24, 48 and 72 hours after application - Evaluation criteria:
- According to guideline.
- Statistics:
- Yes.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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