3,5,5-trimethylhexanoic 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:

1988-07-05 to 1988-07-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

This study was performed according to guideline OECD 471

Cross-reference

Reason / purpose for cross-reference:

other: Purity statement

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Test guideline 4

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Test guideline 5

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

GLP compliance:

yes

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,5,5-trimethylhexanoic acid

EC Number:

221-975-0

EC Name:

3,5,5-trimethylhexanoic acid

Cas Number:

3302-10-1

Molecular formula:

C9H18O2

IUPAC Name:

3,5,5-trimethylhexanoic acid

Test material form:

liquid

Details on test material:

Name of test material (as cited in study report): Isononansäure, 3,5,5-trimethylhexanoic acid

Specific details on test material used for the study:

For details on test material see attached report in section 13

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 fraction of livers from Sprague-Dawley rats, induced with Aroclor 1254

Test concentrations with justification for top dose:

first experiment: 4, 20, 100, 500, 2500, 10000 µg/plate
second experiment: 4, 20, 100, 500, 2500, 5000 µg/plate

top dose selected on basis of highest concentration requested in guideline

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9: sodium azide, 9-aminoacridine, 2-nitrofluorene; with S9: 2-aminoanthracene, benzo[a]pyrene

Details on test system and experimental conditions:

METHOD OF APPLICATION: 2 ml of molten top agar (plate incorporation) with 100 µl of overnight nutrient broth culture of bacteria tester strain and 100 µl of test compound solution with or without 500 µl of S9 mix are poured into a petri dish with a layer of minimal agar. His+ revertants were counted after 48-72 h incubation at 37 °C in the dark.

Evaluation criteria:

A reduced rate of spontaneously occuring colonies as well as visible thinning of the bacterial lawn (controlled microscopically) were used as indicator for toxicity.

Statistics:

Statistical analysis was not stated.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 2500 µg/plate and above in most strains

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 2500 µg/plate and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 2500 µg/plate and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: strain/cell type: WP2 uvr A

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the test substance was not mutagenic with or without metabolic activation.

Executive summary:

The test substance was not mutagenic in an Ames-test with the Salmonella typh. strains TA98, TA100, TA1535, TA1537 and TA1538 and E.coli WP2uvrA in concentrations up to 10000 µg/plate, both with or without metabolic activation (Hoechst AG, 1988).