Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
412-440-4
EC Name:
-
Cas Number:
2725-22-6
Molecular formula:
C33-H39-N3-O2
IUPAC Name:
2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol

Method

Target gene:
Not specified
Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium, TA98, TA100, TA1535, and TA1538
Metabolic activation:
with and without
Metabolic activation system:
Liver microsomal enzymes from male Spraque-Dawley rats
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 667...10000 μg/plate
Concentration range in the main test (without metabolic activation): 667...10000 μg/plate
Vehicle / solvent:
Solvent: Acetone
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
Acetone
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 667 μg/plate
Rationale for test conditions:
not specified
Evaluation criteria:
not specified
Statistics:
not specified

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 μg/plate
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>5000 μg/plate
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>10000 μg/plate
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>10000 μg/plate
Additional information on results:
Observations:
The vihicle control value for tester strain TA98 in the presence of microsomal enzymes was outside the acceptable range. Therefore, tester strain TA98 was retested in the presence of microsomal enzymes.
Remarks on result:
other: other: preliminary test

Applicant's summary and conclusion

Conclusions:
Gene mutation test was performed according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) to determine the mutagenic nature of the test chemical. No cytotoxicity was observed till 10000 μg/plate dose range. Thus the test chemical was considered to be not mutagenic in nature.
Executive summary:

Gene mutation test was performed according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) to determine the mutagenic nature of the test chemical. Salmonella typhimurium, TA98, TA100, TA1535, and TA1538 starins were used with and without metabolic activation system  obtained from Liver microsomal enzymes from male Spraque-Dawley rats. Concentration range in the main test (with metabolic activation): 667 to 10000 μg/plate and Concentration range in the main test (without metabolic activation): 667 to 10000 μg/plate were used. No cytotoxicity was observed till 10000 μg/plate dose range. Thus the test chemical was considered to be not mutagenic in nature.