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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Before BPL and guidelines

Data source

Reference
Reference Type:
publication
Title:
Acetylsalicylic acid: No chromosome damage in human lymphocytes
Author:
Mauer, I. et al.
Year:
1970
Bibliographic source:
Science, Vol.169, N° 3941, 198-201.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
not specified
Principles of method if other than guideline:
ASA was added to culured human lymphocytes at several time periods over a wide range of concentrations in vitro (0.1 to 300 microg/ml) or after human volunters ingestion of 2 tablest (300 mg) 4 times a day for 1 month ( Plasma concentration was measured at each time of harvest.
In vitro addition at To ,T48 or T68 with 4 donors; harvest at 72 hours.
GLP compliance:
no
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Method

Test concentrations with justification for top dose:
0.1 to 300 microg/ml

Results and discussion

Test results
Species / strain:
lymphocytes: human
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
ASA was not inducing chromosomal aberrations in human lymphocytes either by incubation in vitro or after a month administration (2400 mg/day).
Executive summary:

A study was done with human lymphocytes of 4 donors, incubated in vitro for 72 hours, or after 1 month oral ASA administration (2400 mg/day). No combination of the study indicated an effect of ASA on chromosomal aberrations