2,2,4(or 2,4,4)-trimethyladipic acid

Genetic toxicity: in vitro

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

Test material information

Constituent 1

Reference substance name:

Trimethyladipic acid

EC Number:

249-043-9

EC Name:

Trimethyladipic acid

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.