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Registration Dossier
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EC number: 243-718-1 | CAS number: 20298-69-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Aug 2000 to 5 Oct 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC-Guideline 92/69 L 383 A, B.14
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- cis-2-tert-butylcyclohexyl acetate
- EC Number:
- 243-718-1
- EC Name:
- cis-2-tert-butylcyclohexyl acetate
- Cas Number:
- 20298-69-5
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 2-tert-butylcyclohexyl acetate
- Test material form:
- liquid
- Details on test material:
- Test material used is consistent with the substance identity as described in section 1.2 of IUCLID - company composition for the quality described under the common name Verdox.
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, Ta98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9
- Test concentrations with justification for top dose:
- Study 1:
Strains TA971, TA100, TA1535, -S9: 0.016, 0.05, 0.16, 0.5 and 1.6 mg/plate
Strains TA97a (+S9), TA98 (+/-S9), TA100 (+S9), TA1535 (+S9), TA102 (+/-S9): 0.05, 0.16, 0.5, 1.6 and 5 mg/plate
Study 2:
Strains TA97 and TA1535 (-S9): 0.016, 0.05, 0.16, 0.5 and 2.6 mg/plate
Strains TA97 (+ S9), TA98 (+/-S9), TA100 (+/-S9), TA1535 (+S9) and TA102 (+/-S9): 0.05, 0.16, 0.5, 1.6 and 5 mg/plate. - Vehicle / solvent:
- - Vehicle used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR 191, 4-nitro-1,2-phenylenediamine, nitrofurantoine, natrium azide, 2-aminoanthracene, cumene hydroperoxide, danthron.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Incubation period: 18 hours
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 replicates per concentration level and control
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- For evaluation of the results the induction rate of the mean values was calculated: induction rate = (revertant colonies of the test item)/(revertant colonies of the corresponding control). The test item is to be interpretated mutagenic if there is a concentration effect relationship and the induction rate is ≥ 2.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The range of test concentrations was determined in a preliminary (non-GLP) test with the concentration rage 0.05-5 mg/plate (factor 10).
ADDITIONAL INFORMATION ON CYTOTOXICITY: the lowest cytotoxic concentrations were 1.6 mg/plate for TA97a (-S9), 5 mg/plate for TA100 (+/- S9), 1.6 mg/plate for TA1535 (-S9) and 5 mg/plate for TA1535 (+ S9). No cytotoxicity was observed in strains TA97a (+ S9), TA98 (+/-S9) and TA102 (+/-S9). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- The substance gave negative results in the Ames test with Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535, with and without metabolic activation, in a concentration range of 0.016-5 mg/plate.
- Executive summary:
The ability of the test substance to induce gene mutations in Ames test was tested in the GLP-compliant OECD Guideline 471 study in Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535, with and without metabolic activation. The tested concentration ranges were 0.05 -5 mg/plate for strains TA97a (+S9), TA98 (+/-S9), TA100 (+S9), TA102 (+/-S9) and TA1535 (+S9), and 0.016 -1.6 mg/plate for TA97a (-S9), TA100 (-S9) and TA1535 (-S9). The lowest cytotoxic concentrations were 1.6 mg/plate for TA97a (-S9) and TA1535 (-S9), and 5 mg/plate for TA 100 (+/-S9) and TA1535 (+ S9). No cytotoxicity was observed for strains TA97a (+S9), TA98 (+/-S9) and TA102 (+/-S9). The tests were performed in triplicate. No increased number of revertants was observed in any case. Based on the results of the study, the substance is concluded to be negative in Amest test.
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