Registration Dossier
Registration Dossier
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EC number: 617-178-6 | CAS number: 80841-78-7
Genetic toxicity: in vitro
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:
- From 30 May 2012 to 1 June 2012
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: 3a: Documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No reference guideline available.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(chloromethyl)-5-methyl-2H-1,3-dioxol-2-one
- EC Number:
- 617-178-6
- Cas Number:
- 80841-78-7
- Molecular formula:
- C5H5ClO3
- IUPAC Name:
- 4-(chloromethyl)-5-methyl-2H-1,3-dioxol-2-one
- Reference substance name:
- 4-Chloromethyl-5-methyl-1,3-dioxol-2-one
- Cas Number:
- 80841-78-7
- IUPAC Name:
- 4-Chloromethyl-5-methyl-1,3-dioxol-2-one
- Details on test material:
- - Name of test material (as cited in study report): Medoxomyl chloride (SAR408579)
- Lot/batch No.: D136Y82T
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium, other: Mixed strains TA7001 - 7006
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 0, 16, 50, 160 , 500, 1600 and 5000 µg/ml with and without metabolic activation
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- other: 2-aminoanthracene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: TA7001 - 7006 series of Salmonella
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1600 µg/ml and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: TA7001 - 7006 series of Salmonella
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/ml and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 500 µg/ml and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1600 µg/ml and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance is considered to be not mutagenic in a bacterial reverse mutation test under the test conditions.
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