Registration Dossier

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Method

Details on test system and conditions:
Mutagenicity:

Test compound was examined in the
Salmonella/microsome assay (Ames Test) for
mutagenic potential in the standard Salmonella
plate incorporation assay and in the
pre-incubation modification using seven tester
strains. The tests were carried out in the
presence and absence of phenobarbital-induced rat
liver homogenate (S-9) fraction in duplicate
assays.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
no mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:
Based on the available information the substance is not classified
Executive summary:

Mutagenicity: Test compound was examined in the Salmonella/microsome assay (Ames Test) for mutagenic potential in the standard Salmonella plate incorporation assay and in the pre-incubation modification using seven tester strains. The tests were carried out in the presence and absence of phenobarbital-induced rat liver homogenate (S-9) fraction in duplicate assays.

Based on the available information the substance is not classified.