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EC number: 482-140-6 | CAS number: 13641-96-8
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
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:
- Initiation: 14 November 2003 Completion: 11 December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study according to Japanese standards, comparable to OECD 471.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Standards for Mutagenicity Tests using Microorganisms (Notification No. 77 and No. 67, Ministry of Labour, Japan)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for Toxicity Testings of New Chemical Substances (Notification No.5 Environmental Policy Bureau, No. 615 Pharmaceutical and Food Safety Bureau, No. 392 Manufacturing Industries Bureau)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 482-140-6
- EC Name:
- -
- Cas Number:
- 13641-96-8
- Molecular formula:
- Hill formula: C6 H7 N O3 CAS formula: C6 H7 N O3
- IUPAC Name:
- 2-isocyanatoethyl prop-2-enoate
Constituent 1
Method
- Target gene:
- His-operon, Trp-operon
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:
- Phenobarbital- and 5,6-benzoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Range-finder: 1.2, 4.9, 20, 78, 313, 1250, 5000 µg/plate (± metabolic activation)
Main test (+S9): 39, 78, 156, 313, 625, 1250 µg/plate (E. coli additionally 2500 and 5000 µg/plate)
Main test (-S9): TA100, TA1535, E. coli: 39, 78, 156, 313, 625, 1250 µg/plate; TA98, TA1537: 10, 20, 39, 78, 156, 313 µg/plate - Vehicle / solvent:
- Solvent: Dimethyl Sulfoxide (DMSO)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- furylfuramide
- Remarks:
- 0.01 µg/plate (TA100 and WP2uvrA); 0.1 µg/plate (TA98) without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- 0.5 µg/plate TA1535 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine.2HCl
- Remarks:
- 1.0 µg/plate (TA1537) without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- 2.0 µg/plate (TA1535) and 10.0 µg/plate (WP2uvrA) with S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 5.0 µg/plate (TA100, TA98 and TA1537) with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): reversion from histidin- (S. typhimurium) and tryptophan-auxotrophy (WP2uvrA) to prototrophy
NUMBER OF REPLICATIONS: duplicates
DETERMINATION OF CYTOTOXICITY
- Method: other: growth inhibition - Evaluation criteria:
- Significant increase in the number of revertant colonies in comparison with the control plates (twice as many as that of the negative control), dose-response relationship and reproducibility were the criteria for an evaluation as positive for mutagenicity.
- Statistics:
- Not performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 156 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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:
- not examined
- True negative controls validity:
- not examined
- 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:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 1250 µg/plate in all strains
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
In the dose-finding test, growth inhibition was observed at 313 micrograms/plate and more in S. typhimurium TA98 and TA1537 without metabolic activation, at 1250 micrograms/plate and more in S. typhimurium TA100, TA1535 and E. coli WP2uvrA without metabolic activation, and at 1250 micrograms/plate and more in all strains with metabolic activation. Moreover, an increase in the number of revertant colonies more than twice as many as that of negative control was observed in S.typhimurium TA98 without metabolic activation and in E. coli WP2uvrA with metabolic activation. Precipitate was not observed on the plates treated with test substance, with or without metabolic activation.
Any other information on results incl. tables
Maximum number of revertants (average of duplicates):
|
-S9 |
+S9 |
||||
Strain |
Vehicle |
AOI (µg/plate) |
Pos. control |
Vehicle |
AOI (µg/plate) |
Pos. control |
TA100 |
126 |
173 (313) |
633 |
137 |
172 (313) |
725 |
TA1535 |
20 |
22 (1.2) |
453 |
13 |
14 (20) |
359 |
TA98 |
17 |
36 (78) |
496 |
29 |
38 (313) |
213 |
TA1537 |
10 |
13 (4.9) |
2001 |
22 |
27 (1.2) |
68 |
WP2uvrA |
23 |
35 (1250) |
151 |
30 |
99 (5000) |
525 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: positive
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