Registration Dossier
Registration Dossier
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EC number: 213-426-9 | CAS number: 947-19-3
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:
- From May 9, 1980 to Sep. 15, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- 2-aminoanthracene was the only compound used to test the efficacy of the S9 fraction; missing some positive controls, no repeat study
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydroxycyclohexyl phenyl ketone
- EC Number:
- 213-426-9
- EC Name:
- Hydroxycyclohexyl phenyl ketone
- Cas Number:
- 947-19-3
- Molecular formula:
- C13H16O2
- IUPAC Name:
- 1-benzoylcyclohexan-1-ol
Constituent 1
Method
- Target gene:
- Histidine (his- to his+) and tryptophan (tryp- to tryp+) genes in Salmonella typhimurium and Escherichia coli respectively
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range (-S9 mix): 5, 10, 50, 100, 500, 1000 and 5000 µg/0.1 ml
Concentration range (+S9 mix): 5, 10, 50, 100, 500, 1000 and 5000 µg/0.1 ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- other: same as negative control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see Table 1
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Amount per plate: 0.1 mL
DURATION
- Exposure duration: 48-55 hours at 37°C
NUMBER OF REPLICATIONS: 3 plates per strain per group.
-No independent repeat experiment was conducted.
TOXICITY TEST:
- In order to estimate a growth-inhibiting effect of the test substance on the bacteriam a plate test without microsomal activation was performed on Strain TA 100 with the following concentrations: 0.0001, 0.001, 0.01, 0.1, 1, 10, 50, 100, 500, 1000 and 2000 µg/0.1 mL. - Evaluation criteria:
- The test substance is generally considered to be nonmutagenic if the colony count in relation to the negative control is not doubled at any concentration.
- Statistics:
- The arithmetic mean was calculated when the colonies had been counted. No statistical analysis test was performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- other: same as negative control
- Untreated negative controls validity:
- valid
- Positive controls validity:
- other: valid for all strains without S9 mix and for TA 1535 with S9 mix; not examined for TA1537, TA98 and TA100 with S9 mix
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/0.1 ml
- Vehicle controls validity:
- other: same as negative control
- Untreated negative controls validity:
- valid
- Positive controls validity:
- other: valid for all strains without S9 mix and for TA 1535 with S9 mix; not examined for TA1537, TA98 and TA100 with S9 mix
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/0.1 ml
- Vehicle controls validity:
- other: same as negative control
- Untreated negative controls validity:
- valid
- Positive controls validity:
- other: valid for all strains without S9 mix and for TA 1535 with S9 mix; not examined for TA1537, TA98 and TA100 with S9 mix
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/0.1 ml
- Vehicle controls validity:
- other: same as negative control
- Untreated negative controls validity:
- valid
- Positive controls validity:
- other: valid for all strains without S9 mix and for TA 1535 with S9 mix; not examined for TA1537, TA98 and TA100 with S9 mix
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/0.1 ml
- Vehicle controls validity:
- other: same as negative control
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/0.1 ml
- Vehicle controls validity:
- other: same as negative control
- Untreated negative controls validity:
- valid
- Positive controls validity:
- other: valid without S9 mix; not examined with S9 mix
- Additional information on results:
- At the concentration of 5000 µg/0.1 ml the substance precipitated in soft agar.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In the experiments performed with and without microsomal activation, comparison of the number of histidine- or tryptophanprototrophic mutants in the controls and after treatment with the test item revealed no marked differences. A growth-inhibiting effect of test item
was observed with all strains at the concentration of 5000 µg/0.1 ml. At the concentration of 5000 µg/0.1 ml the substance precipitated in soft agar.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay under the test conditions.
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