1-isopropyl-4-methylcyclohexane

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:

16/05 to 09/07 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test according to the guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

yes

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-isopropyl-4-methylcyclohexane

EC Number:

202-790-4

EC Name:

1-isopropyl-4-methylcyclohexane

Cas Number:

99-82-1

Molecular formula:

C10H20

IUPAC Name:

1-methyl-4-(propan-2-yl)cyclohexane

Constituent 2

Reference substance name:

p-menthane

IUPAC Name:

p-menthane

Details on test material:

- Name of test material (as cited in study report): p-menthane
- Stability under test conditions: stable

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, other: TA 1538

Metabolic activation:

with and without

Metabolic activation system:

rat liver derived S9

Test concentrations with justification for top dose:

plate incorporation test: 8, 40, 200, 1000, 5000 ug/plate
pre-incubation test: 8, 40, 200, 1000, 5000 ug/plate

Vehicle / solvent:

acetone

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

acetone

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

TA98 and TA1538 without metabolic activation

Controls 2

Negative solvent / vehicle controls:

yes

Remarks:

acetone

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA1537 without metabolic activation

Controls 3

Negative solvent / vehicle controls:

yes

Remarks:

acetone

Positive control substance:

other: amino anthracene TA 100 with metabolic activation

Controls 4

Negative solvent / vehicle controls:

yes

Remarks:

acetone

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA100 and TA1535 without metabolic activation

Details on test system and experimental conditions:

TEST 1

METHOD OF APPLICATION: plate incorporation
DURATION: 96 hour
NUMBER OF REPLICATIONS: 3

TEST 2

METHOD OF APPLICATION: pre-incubation (30 min)
DURATION: 96 hour
NUMBER OF REPLICATIONS: 3

Evaluation criteria:

according to Ames

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 ug/plate in TA 1537

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 ug/plate in without S9; no cytotoxicity with S9

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: plate incorporation test

Applicant's summary and conclusion

Conclusions:

negative without metabolic activation
negative with metabolic activation

negative with and without metabolic activation

Executive summary:

The test substance was tested in a plate incorporation and a pre-incubation assay with Salmonella typhimurium strains TA 98, TA100, TA 1535, TA 1537 and TA 1538. In absence and presence of metabolic activation (rat S9) no mutagenicity was observed in any of the strains tested.