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Toxicological information

Genetic toxicity: in vitro

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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:
1992
Bibliographic source:
Environ. Molec. Mutagen. 19 (Suppl.21), 2-141

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Na3.NTA.H2O, commercial, purity 89%

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