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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.

Data source

Reference
Reference Type:
other: Body responsilble for test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (Ames)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Remarks:
and TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 10 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 10 ... 5000 μg/plate
Vehicle / solvent:
Solvent: Dimethylsulfoxide
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
other: 4-nitro-ortho-ohenylenediamine and 2-aminoanthracene
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 333 μg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: Strains as specified above, preliminary test
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>5000 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
primary culture, other: Strains as specified above, preliminary test
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
other: Strains as specified above, main test
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
other: Strains as specified above, main test
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>5000 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
Observations: The plates incubated with the test substance showed normal background growth at concentrations up to 5000 µg/plate. No increases in the numbers of revertant colonies were seen at any of the concentrations of the test substance with or without metabolic activation.

Positive control substances sodium azide, 4-nitro-ortho-ohenylenediamine) and 2-aminoanthracene led to increases in induce revertant colonies in the appropriate bacterial strains.

Applicant's summary and conclusion

Conclusions:
The Ames test was negative with metabolic activation and without metabolic activation.
Executive summary:

The test item was investigated for in vitro genetic toxicity at the concentration in an Ames test with a concentration range of 10 to 5000 μg/plate, with and without metabolic activation, following a standard guideline. The study included TA98, TA100, TA1535, TA1537 and TA1538 strains. Positive control substances were also included. The Ames test was negative with metabolic activation and negative without metabolic activation as no increases in the numbers of revertant colonies were seen at any of the concentrations of the test substance, with or without metabolic activation.

The study is a GLP compliant, guideline study and is acceptable with restrictions for assessment of this endpoint.