Registration Dossier
Registration Dossier
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EC number: 800-430-6 | CAS number: 1419212-76-2
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:
- 05-06-2013 to 19-07-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to the guidelines, under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2Z)-3-({2-[(8E)-9-(1,3-dioxo-7-pentyl-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)non-8-enamido]ethyl}({2-[(9E)-octadec-9-enamido]ethyl})carbamoyl)prop-2-enoic acid; (2Z)-3-[bis({2-[(8E)-9-(1,3-dioxo-7-pentyl-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)non-8-enamido]ethyl})carbamoyl]prop-2-enoic acid; (2Z)-3-[bis({2-[(9E)-octadec-9-enamido]ethyl})carbamoyl]prop-2-enoic acid
- EC Number:
- 800-430-6
- Cas Number:
- 1419212-76-2
- Molecular formula:
- ca. C44H75N3O5 - C48H81N305
- IUPAC Name:
- (2Z)-3-({2-[(8E)-9-(1,3-dioxo-7-pentyl-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)non-8-enamido]ethyl}({2-[(9E)-octadec-9-enamido]ethyl})carbamoyl)prop-2-enoic acid; (2Z)-3-[bis({2-[(8E)-9-(1,3-dioxo-7-pentyl-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)non-8-enamido]ethyl})carbamoyl]prop-2-enoic acid; (2Z)-3-[bis({2-[(9E)-octadec-9-enamido]ethyl})carbamoyl]prop-2-enoic acid
- Test material form:
- other: gel
- Details on test material:
- - Substance type: UVCB
- Physical state: paste
- Purity: 100% (UVCB)
- Storage condition of test material: room temperature in dark
Constituent 1
Method
- Target gene:
- Salmonella typhimurium: histidine
E-coli: tryptophan
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:
- S9 from rats induced with Phenobarbitone/ß-Naphthoflavone
- Test concentrations with justification for top dose:
- exp. 1 : 1.5, 5, 15, 50, 150, 500, 1500 and 5000 ug/plate
exp. 2: 50, 150, 500, 1500 and 5000 ug/plate - Vehicle / solvent:
- acetone (100 mg/mL),
volume of preparations added to the wells was adjusted to prevent toxic effects of acetone
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- for TA100, TA1535 and WP2uvrA without metabolic activation
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- for TA1537 without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- for TA98 without metabolic acivation
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- for TA100, TA1535, TA 1537 and WP2uvrA with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylformamide
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- for TA98 with metabolic activation
- Positive control substance:
- benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 1st test in agar (plate incorporation); 2nd test preincubation
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48 hours at 37°C
NUMBER OF REPLICATIONS: 3/concentration
DETERMINATION OF CYTOTOXICITY
- Method: growth rate bacterial bachground lawn
COLONY COUNT:
automated colony counter - Evaluation criteria:
- A test item will be considered mutagenic (positive) in the test system if one or more of these criteria are met
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby (1979)).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response). - Statistics:
- Not specified according to UKEMS
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:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitate at 5000 ug/plate (greasy and particulate)
- 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, but tested up to precipitating concentrations
- Remarks:
- precipitate at 5000 ug/plate (greasy and particulate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- negative without metabolic activation
negative with metabolic activation
The test substance did not induce mutations (base-pair substitution and frame-shift type) in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 as well as in E. coli WP2 uvr A both in presence and absence of metabolic activation. - Executive summary:
The test substance was tested in an Ames test at concentrations upto the preciptation level (5000 ug/plate). In a plate incorporation and a pre-incubation assay (both performed in triplicate), the test substance did not induce mutations (base-pair substitution and frame-shift type) in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537, as well as in E. coli WP2 uvr A both in presence and absence of metabolic activation.
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