Registration Dossier

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
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:
according to
Guideline:
other: see Principles of method if other than guideline
Principles of method if other than guideline:
Ames BN et al. (1975). Mutat. Res. 31, 347-364
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
cis-3,3,5-trimethylcyclohexanol of Hüls AG, ID 536/880202, commercial quality, purity not reported

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
10; 50; 250; 1000; 2000; 5000 µg/plate
Vehicle / solvent:
Dimethyl sulfoxide (CAS: 67-68-5)
Details on test system and experimental conditions:
Type: Ames test

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: >= 1000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

GENOTOXIC EFFECTS: 
- With metabolic activation: None
- Without metabolic activation: None
  The positive controls were functional.
PRECIPITATION CONCENTRATION: No precipitation was observed.
CYTOTOXIC CONCENTRATION: 
  TA 98: 5000 µg/plate (+/- S9)
  TA 100: 5000 µg/plate (+/- S9)
  TA 1535: 5000 µg/plate (+ S9), 250/1000 µg/plate (- S9)
  TA 1537: 5000 µg/plate (+ S9), 1000 µg/plate (- S9)
  TA 1538: 5000 µg/plate (+/- S9)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative +/- S9

The test substance was found not to be genotoxic in an Ames test with and without metabolic activation
Executive summary:

The test substance was found not to be genotoxic in an Ames test with and without metabolic activation.