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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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Method and results sufficient described, similar to OECD method.

Data source

Reference
Reference Type:
publication
Title:
Salmonella mutagenicity test results for 250 chemicals
Author:
Haworth S., Lawlor T., Mortelmans K., Speck W., Zeiger E.
Year:
1983
Bibliographic source:
Environ. Mutagenesis 5(Suppl. 1), 51: 108 (1983)

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:
Obtained from MC/B, Lot E7. Purity not reported

Method

Target gene:
his-
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:
Aroclor 1254 induced rat and hamster S9-mix
Test concentrations with justification for top dose:
33 - 4000 µg/plate
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Remarks:
2-Aminoanthracene; 4-Nitro-o-phenylenediamine; Sodium azide; 9-Aminoacridine
Evaluation criteria:
Positive result indicated by a reproducible, dose related increase.
Statistics:
Margolin et al., 1981

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
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Using a scientifically valid methods, MAA was negative for mutagenicity in Salmonella tester strains.
Executive summary:

Using a scientifically valid methods, MAA was negative for mutagenicity in Salmonella tester strains.