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Key value for chemical safety assessment

Genetic toxicity in vivo

Description of key information
A study combined a 14 -day toxicologcal study in rats with final examination of micronuclei in bone marrow erythrocytes. The resulst at 750 mg/kg were negative and in line with existing literature ( MacGegor, 1990).
Link to relevant study records
Reference
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)
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
Species:
rat
Strain:
Fischer 344
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
Tissues and cell types examined:
Bone marrow cells

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.

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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vivo:

Furthermore all the other in vitro studies were negative.


Justification for selection of genetic toxicity endpoint
Micronucleus study in vivo is the recommended one for C&L.

Justification for classification or non-classification

As in vitro and in vivo studies are concluded negative , ASA is not classified for genotoxicty.