Registration Dossier
Registration Dossier
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EC number: 237-492-3 | CAS number: 13816-33-6
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:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in 2014 study at recognised contract research organisation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-isopropylbenzonitrile
- EC Number:
- 237-492-3
- EC Name:
- 4-isopropylbenzonitrile
- Cas Number:
- 13816-33-6
- Molecular formula:
- C10H11N
- IUPAC Name:
- 4-(propan-2-yl)benzonitrile
- Test material form:
- other: liquid
- Details on test material:
- Batch SC00008199
Purity 99.5%
Expiry date 19 August 2016
Constituent 1
Method
- Target gene:
- Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% liver S9 in standard co-factors
- Test concentrations with justification for top dose:
- Experiment 1: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate) with and without metabolic activation.
Experiment 2:
Salmonella strains TA1535 and TA98 (absence of S9-mix) and E.coli strain WP2uvrA (absence and presence of S9-mix): 0.5, 1.5, 5, 15, 50, 150, 500 μg/plate.
Salmonella strains TA100 (absence and presence of S9-mix), TA1535 (presence of S9-mix) and TA1537 (absence of S9-mix): 5, 15, 50, 150, 500, 1500, 5000 μg/plate.
Salmonella strains TA98 and TA1537 (presence of S9-mix): 15, 50, 150, 500, 1500, 5000 μg/plate. - Vehicle / solvent:
- Dimethyl sulphoxide was selected as the vehicle.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- 2 μg/plate for WP2uvrA without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- 3 μg/plate for TA100 without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- 5 μg/plate for TA1535 without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 80 μg/plate for TA1537 without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 0.2 μg/plate for TA98 without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- 1 μg/plate for TA100 with S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- 2 μg/plate for TA1535 and TA1537 with S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- 10 μg/plate for WP2uvrA with S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Vehicle, negative (untreated)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 5 μg/plate for TA98 with S9-mix
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see additional information on results
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The first experiment was selected as the maximum recommended dose level of 5000 μg/plate. In the first mutation test (plate incorporation method), the test item caused a visible reduction in the growth of the bacterial background lawns of all of the Salmonella tester strains initially from 1500 μg/plate in both the absence and presence of S9-mix. No toxicity was noted to Escherichia coli strain WP2uvrA either in the absence or presence S9-mix.
In the second mutation test (pre-incubation method), the test item induced a stronger toxic response with weakened bacterial background lawns noted in the absence of S9-mix from 150 μg/plate (TA1535 and TA98) and 500 μg/plate (TA100, TA1537 and WP2uvrA). In the presence S9-mix weakened bacterial background lawns were noted from 500 μg/plate (TA100, TA1535 and WP2uvrA) and 1500 μg/plate (TA98 andTA1537).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Cumin Nitrile was considered to be non-mutagenic under the conditions of this test.
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