Registration Dossier
Registration Dossier
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EC number: 225-060-7 | CAS number: 4635-87-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- Remarks:
- Concentration, stability, and homogeneity of formulations not determined. However preparation was performed with approved procedures and documented in detail. Homogeneity was visually inspected prior to use. Test items used within 4 h after preparation.
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
Test material
- Reference substance name:
- Pent-3-enenitrile
- EC Number:
- 225-060-7
- EC Name:
- Pent-3-enenitrile
- Cas Number:
- 4635-87-4
- Molecular formula:
- C5H7N
- IUPAC Name:
- (3E)-pent-3-enenitrile
- Details on test material:
- - Name of test material (as cited in study report): 3-Pentenenitrile
- Analytical purity: > 95 %
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- The test item was tested up to concentrations of 811.2 µg/mL (0.01 M)
in the absence and presence S9-mix, respectively. This is the highest concentration
recommended in the guideline. - Vehicle / solvent:
- DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- 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
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, 3-PENTENENITRILE is not mutagenic in the mouse lymphoma L5178Y test
system under the experimental conditions described in the test
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