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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Identity of all tested Salmonella strains not provided
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1-[4-(2-methylpropyl)phenyl]ethan-1-ol
Cas Number:
40150-92-3
Molecular formula:
C12 H18 O
IUPAC Name:
1-[4-(2-methylpropyl)phenyl]ethan-1-ol
Details on test material:
No further data provided

Method

Target gene:
His gene
Species / strain
Species / strain / cell type:
S. typhimurium, other: 5 strains tested (not fully specified)
Metabolic activation:
with and without
Metabolic activation system:
not specified
Test concentrations with justification for top dose:
Top dose was defined by range finding study:
- Rangefinder: 50 - 5000 µg/plate;
- 1st run: 15-1500 µg/plate + two lower concentrations for TA 98 (not specified);
- 2nd run: 5-500 µg/plate + 1.5 µg/plate for TA 98, TA 100
Vehicle / solvent:
- Solid test material in DMSO
- Dilutions prepared such that 100 μl of DMSO solution provided plate concentration from 50 - 5000 µg test material/plate.
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 98, TA100 (further strains not specified)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
True negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
Range-finding study :
Toxicity was generally observed only at dose levels of 5000 µg/plate, except for TA 98 where toxicity was recorded at 500 μg/plate in the presence of metabolic activation.

Main test (1st, 2nd run):
No signiflcant positive responses were recorded in the presence of test material.
All concurrent positive and negative controls were within the normal range.

Applicant's summary and conclusion

Conclusions:
Not mutagenic in bacteria