Registration Dossier
Registration Dossier
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EC number: 247-724-5 | CAS number: 26472-00-4
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted GLP compliant study according to internatially recognised methods
Data source
Reference
- Reference Type:
- other: USEPA High Production Volume Information System (HPVIS)
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methylcyclopentadiene
- EC Number:
- 247-724-5
- EC Name:
- Methylcyclopentadiene
- Cas Number:
- 26472-00-4
- Molecular formula:
- not applicable, UVCB substance
- IUPAC Name:
- 3a,4,7,7a-tetrahydro-1H-4,7-methanoindene
- Test material form:
- liquid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 15, 50, 150, 500, 1500 and 5000 micrograms/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- -S9 TA98
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- -S9 TA100 and TA1535
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- -S9 TA1537
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- -S9 WP2uvrA
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoantracene
- Remarks:
- +S9 all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 - 72 hours
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- Revertant rate
- Statistics:
- Significance (in response) considered as:
- number of revertants is 2x (strains TA98, TA100 and WP2uvrA) or 3x (strains TA1535 and TA1537) higher than spontaneous reversion rate of solvent controls
- dose dependent increase in revertant rate over a minimum of 2 increasing concentrations
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 500 microgram/plate
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No precipitation was observed. Toxicity was observed beginning at 500, 1500 or 5000 µg/plate with some Salmonella strains. No toxicity was
observed with E.coli .
The test substance did not induce a dose-related or 2-fold or 3-fold increase in the number of revertant colonies in any Salmonella strain or in E.coli WP2 u vrA either in the presence or absence of metabolic activation. - Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance does not induce point mutations by base pair changes of frameshifts in the genome of the tester strains used - Executive summary:
The substance does not induce point mutations by base pair changes of frameshifts in the genome of the tester strains used
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