Registration Dossier
Registration Dossier
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EC number: 400-820-2 | CAS number: 84268-33-7
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:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Non-Annex V (Cytogenetics)
- Deviations:
- not specified
- Principles of method if other than guideline:
- This non-Annex V test was designed to detect nuclear anomalies (micronuclei, nuclear fragments and polyploidy) in erythrocytes and other bone marrow cells.
- GLP compliance:
- yes
- Type of assay:
- other: in vivo mammalian bone marrow cytogenetic test
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- 0.5% aqueous sodium carboxymethylcellulose plus 0.1% Tween 80.
- Frequency of treatment:
- Dosing was on two consecutive days with animals being killed 24 hours later.
- No. of animals per sex per dose:
- Male: 0 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Male: 560 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Male: 1120 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Male: 2240 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Female: 560 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Female: 1120 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Female: 2240 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- not specified
- Toxicity:
- yes
- Remarks:
- Doses producing toxicity: In a preliminary test 1 out of 4 animals died after a single application of 2800 mg/kg. No effects evident in bone marrow.
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- other: Positive control gave a satisfactory response.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The substance was non mutagenic under the conditions of the test.
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