Registration Dossier
Registration Dossier
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EC number: 225-768-6 | CAS number: 5064-31-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: comparable to guidelines, comprehensive evaluation programme
Data source
Reference
- Reference Type:
- publication
- Title:
- Salmonella Mutagenicity Tests: V. Results from the Testing of 311 Chemicals.
- Author:
- Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., Mortelmans, K.
- Year:
- 1 992
- Bibliographic source:
- Environ. Molec. Mutagen. 19 (Suppl.21), 2-141
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- trisodium 2-[bis(carboxylatomethyl)amino]acetate hydrate
- EC Number:
- 606-091-9
- Cas Number:
- 18662-53-8
- Molecular formula:
- C6H8NNa3O7
- IUPAC Name:
- trisodium 2-[bis(carboxylatomethyl)amino]acetate hydrate
- Details on test material:
- Na3.NTA.H2O, commercial, purity 89%
Constituent 1
Method
- Target gene:
- S. typhimurium
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA100, 98, 1535, 1537, 97
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S-9 mix
- Test concentrations with justification for top dose:
- 0, 33 - 2000 ug/plate
- Vehicle / solvent:
- The solvent of choice was distilled water, followed by dimethyl sulfoxide (DMSO), 95% ethanol, and acetone.
- Details on test system and experimental conditions:
- Salmonella typhimurium strains were obtained from Dr . Bruce Ames (University of California, Berkeley) and stored as recommended [Maron and Ames,
19831. Cultures were grown at 37°C overnight, with shaking, in Oxoid #2 broth (CWR, MIC), or in defined minimal medium supplemented with biotin (0.8 ug/ml) and histidine (40 ug/ml) (SRI). The phenotypes of the strains were analyzed at the time of their use in mutagenicity assays.
The S-9 (9,000 X g supernatant) fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared as described previously [Haworth et al ., 1983]. The S-9 mixes were prepared immediately prior to use and contained either 10% or 30% S-9; occasionally, 5% S-9 was also used. All chemicals were tested in the absence of metabolic activation, and with rat and hamster S-9 fractions.
Results and discussion
Test results
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks on result:
- other: other: Salmonella typhimurium TA100, 98, 1535, 1537, 97
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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