Registration Dossier
Registration Dossier
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EC number: 210-807-1 | CAS number: 623-68-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-butenoic anhydride
- EC Number:
- 210-807-1
- EC Name:
- 2-butenoic anhydride
- Cas Number:
- 623-68-7
- Molecular formula:
- C8H10O3
- IUPAC Name:
- (2E)-but-2-enoyl (2E)-but-2-enoate
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat Liver
- Test concentrations with justification for top dose:
- 4 - 5000 µg/Plate
- Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene for all strains with metabolic activation
Results and discussion
Test results
- Key result
- Species / strain:
- other: All tested strains
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed above 100µg/plate without metabolic activation. In the presence of metabolic activation the substance was found to be toxic to all strains at 500µg/plate and above.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Mutagenicity: In the absence and in the presence of the metabolic activation system Crotonsaureanhydrid did not result in relevant increases in the number of revertants in any of the bacterial strains.
Summarising, it can be stated that Crotonsaureanhydrid is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.
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