Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-064-1 | CAS number: 50-78-2
Genetic toxicity: in vitro
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:
- 1 970
- Bibliographic source:
- Science, Vol.169, N° 3941, 198-201.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 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: crystalline
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
