Registration Dossier
Registration Dossier
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EC number: 423-800-5 | CAS number: 7305-71-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- pH and osmolality were measured retrospectively, the concentration of (ADR) was 0.05 µg/ml. The result of the 1st experiment was clear, so the repeat was not evaluated. The authors considered that these did not affect the conclusions of the study.
- GLP compliance:
- yes
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Reference substance name:
- 2-amino-5-methylthiazole
- EC Number:
- 423-800-5
- EC Name:
- 2-amino-5-methylthiazole
- Cas Number:
- 7305-71-7
- Molecular formula:
- C4 H6 N2 S
- IUPAC Name:
- 5-methyl-1,3-thiazol-2-amine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Chbb:THOM (SPF)
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: unspecified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 20 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- No. of animals per sex per dose:
- 5 males/dose, except 500 mg/kg bw/day, where 10 males were used, with analysis of 5 males at 24 hours and 5 males at hours
- Control animals:
- yes
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
Applicant's summary and conclusion
- Conclusions:
- No treatment-related increase of micronuclei (chromosomal damage).
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