Registration Dossier

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
Study period:
1988-05-18 to 198-05-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions: Incomplete documentation, TA 102 or E.coli WP2 were not tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: Ames BN et al. (1975). Mutat. Res. 31, 347-364
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
(2,2,4/2,4,4)-Trimethyladipic acid of Hüls AG, ID 548/880202, purity not reported

Method

Target gene:
mutated gene loci responsible for histidine auxotrophy
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Additional strain / cell type characteristics:
other: histidine auxotroph
Metabolic activation:
with and without
Metabolic activation system:
Arochlor induced rat liver S9 mix, male Bor: W/SW (SPF/TNO) rats
Test concentrations with justification for top dose:
10 to 5000 µg/plate
Vehicle / solvent:
DMSO (Dimethylsufoxid) (CAS No. 67-68-5)
Controls
Untreated negative controls:
other: not reported
Negative solvent / vehicle controls:
other: not reported
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2.5 µg nitrofluorene/plate: TA 98, TA 1538; 2.5 µg sodium azide/plate: TA 100, TA 1535; 50 µg aminoacridine/plate: TA 1537
Details on test system and experimental conditions:
Ames test
Evaluation criteria:
CRITERIA FOR EVALUATING RESULTS: mutagenic effects (i.e  ratio of revertant rates treated/control >= 2) at <= 5000 µg/plate with generally 
positive dose-response relationship in any strain

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: not reported; probably not observed
Vehicle controls validity:
other: not reported
Untreated negative controls validity:
other: not reported
Positive controls validity:
other: not reported
Remarks on result:
other: other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance 2,2,4(or 2,4,4)-trimethylhexanedioic acid proved to be non-mutagenic under the conditions of this study, both in the presence
and in the absence of Arochlor-induced liver microsomes for all the test strains even at addition of 5,000 µg of test substance per plate and when thepre-incubation test was used.
Executive summary:

The test substance 2,2,4(or 2,4,4)-trimethylhexanedioic acid was tested in the Ames Salmonella/microsomes mutagenicity test for any mutagenic activity. The test organisms were five histidine-auxotrophic Salmonella typhimurium strains. The test substance concentrations were in the range between 10 and 5,000 µg/plate. The test substance 2,2,4(or 2,4,4)-trimethylhexanedioic acid proved to be non-mutagenic under the conditions of this study, both in the presence and in the absence of Arochlor-induced liver microsomes for all the test strains even at addition of 5,000 µg of test substance per plate and when the pre-incubation test was used.