Registration Dossier
Registration Dossier
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EC number: 200-186-5 | CAS number: 53-86-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable publication which meets basci scientific principles, GLP status not indicated
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Salmonella mutagenicity tests: II. results from the testing of 270 chemicals
- Author:
- Mortelmans, K. et al.
- Year:
- 1 986
- Bibliographic source:
- Environmental Mutagenesis, 8 (Suppl.7): 1-119
Materials and methods
- Principles of method if other than guideline:
- A reverse mutation assay (Ames test) was performed with Indomethacin in four Salmonella typhimurium strains with and without liver S-9 mix (rat and hamster )
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Indometacin
- EC Number:
- 200-186-5
- EC Name:
- Indometacin
- Cas Number:
- 53-86-1
- Molecular formula:
- C19H16ClNO4
- IUPAC Name:
- 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid
- Details on test material:
- Indomethacin was supplied by Sigma Chemical Co.
Constituent 1
Method
- Target gene:
- Histidine gene locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix of SD- rat/Syrian hamsters induced by Aroclor 1254 (500 mg/kg)
- Test concentrations with justification for top dose:
- 0, 5.3, 10, 53, 100, 535 and 1000 µg/plate
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Executive summary:
The reverse mutation assay with indomethacin in four S. typhimurium strains (TA 1535, TA 1537, TA98 and TA100) with and without metabolic activation (S9 mix - rat and hamster liver) was negative up to and including 1 mg/plate.
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