Registration Dossier
Registration Dossier
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EC number: 200-064-1 | CAS number: 50-78-2
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- The in vivo rat micronucleus test: integration with a 14-day study.
- Author:
- Garriott M.L. et al.
- Year:
- 1 995
- Bibliographic source:
- Mutation Research 342, 71-76
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- A micronucleus assay was done at the end of a 14-day subchronic toxicity study.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- O-acetylsalicylic acid
- EC Number:
- 200-064-1
- EC Name:
- O-acetylsalicylic acid
- Cas Number:
- 50-78-2
- Molecular formula:
- C9H8O4
- IUPAC Name:
- 2-acetoxybenzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- once a day
- Post exposure period:
- 24 hours
- No. of animals per sex per dose:
- 5 M and 5 F
Examinations
- Tissues and cell types examined:
- Bone marrow cells
Results and discussion
Any other information on results incl. tables
No MPCE in males up to 750 mg/kg bw/d, slightly positive in females at 750 mg/kg bw/day, not considered positive due to a low MPCE in the corresponding control female, compared to the other groups tested, including controls of positive controls 6 -MP and cyclophosphamide.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In a 1'-day toxicological study in rats, ASA did not induced micronucleus up to 750 mg/kg/day. - Executive summary:
A study combined a 14 -day toxicological study in rats with final examination of micronuclei in bone marrow erythrocytes. The resulst were negative and in line with existing literature ( MacGegor, 1990).
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