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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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-isopropyl-4-methylcyclohexane
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
acetone
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA98 and TA1538 without metabolic activation
Negative solvent / vehicle controls:
yes
Remarks:
acetone
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA1537 without metabolic activation
Negative solvent / vehicle controls:
yes
Remarks:
acetone
Positive control substance:
other: amino anthracene TA 100 with metabolic activation
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 resultsopen allclose all
Key result
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
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
Key result
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 5000 ug/plate in TA 1537 (and TA 1535 without S9)
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 acivation
Executive summary:

The testsubstance 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.