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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Similar to OECD-guideline 471.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1987
Reference Type:
publication
Title:
Mutagenicity of 42 chemicals in Salmonella
Author:
Zeiger E.
Year:
1990
Bibliographic source:
Environ. Mol. Mutagen. 16: 32-54
Reference Type:
publication
Title:
Unnamed
Year:
1986

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

Method

Target gene:
his-
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
AROCLOR 1254 induced rat and Syrian hamster liver S9 mix.
Test concentrations with justification for top dose:
10 - 10000 ug/plate
At least five doses tested in triplicate.
Vehicle / solvent:
Not specified: vehicles used included water, DMSO, ethanol or acetone
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: without S9: sodium azide, 9-aminoacridine and 4-nitro-o-phenylenediamine. With S9: 2-aminoanthracene
Details on test system and experimental conditions:
Salmonella typhimurium reverse mutation assay
Two preincubation assays were conducted.
Evaluation criteria:
An individual trial was judged (+) mutagenic if a dose related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic (+W) if a low dose response was seen. A trial was considered questionable (?) if a dose related increase was judged insufficiently high to justify a call of "+W" if only a single dose was elevated over control or if a non-dose related increase was seen. A chemical was judged weakly mutagenic "+W' or mutagenic "+" if it produced a reproducible, dose related increase in his+ revertants over the corresponding solvent controls in replicate trials.

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, 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

Conclusions:
Using a valid scientific method, MMA was negative for genotoxicity in the Salmonella typhimurium reverse mutation assay.
Executive summary:

Using a valid scientific method, MMA was negative for genotoxicity in a Salmonella typhimurium reverse mutation assay.