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Diss Factsheets
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EC number: 203-700-6 | CAS number: 109-74-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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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: Study was conducted in a GLP facility under OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Butyronitrile
- EC Number:
- 203-700-6
- EC Name:
- Butyronitrile
- Cas Number:
- 109-74-0
- Molecular formula:
- C4H7N
- IUPAC Name:
- butanenitrile
- Details on test material:
- Test material was supplied as a liquid
Constituent 1
Method
- Target gene:
- His gene and uvr B genes
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver microsomes from Arochlor 1254 treated rats
- Test concentrations with justification for top dose:
- 5000, 3330, 1000, 333 and 100 ug/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene, ICR-191
- Evaluation criteria:
- Criteria for a Valid Assay
The following criteria were used to determine a valid assay:
1. Tester Strain Integrity: Salmonella typhimurium
a. rfa Wall Mutation
To demonstrate the presence of the rfa wall mutation, tester strain
cultures exhibited sensitivity to crystal violet.
b. pKMlOl Plasmid
To demonstrate the presence of the R-factor plasmid, PKM101,
cultures of tester strains TA98 and TAl00 exhibited resistance to ampicillin.
c. Characteristic Number of Spontaneous Revertants
To demonstrate the requirement for histidine, the tester strain
cultures exhibited a characteristic number of spontaneous revertants per plate when plated along
with the vehicle under selective conditions. The acceptable ranges for the vehicle controls were
as follows:
TA98 8 - 60
TAl00 60 - 240
TA1535 4 - 45
TA1537 2 - 25
Criteria for a Positive Response
Once the criteria for a valid assay had been met, responses observed in the assay
were evaluated as follows:
Tester Strains TA98, TAI00, and WP2uvrA(PKM 101)
For a test article to be considered positive, it had to produce at least a
2-fold increase in the mean revertants per plate of at least one of these tester strains over the
mean revertants per plate of the appropriate vehicle control. This increase in the mean number of
revertants per plate had to be accompanied by a dose response to increasing concentrations of the
test article.
2. Tester Strains TAI535 and TA1537
For a test article to be considered positive, it had to produce at least a
3-fold increase in the mean revertants per plate of at least one of these tester strains over the
mean revertants per plate of the appropriate vehicle control. This increase in the mean number of
revertants per plate had to be accompanied by a dose response to increasing concentrations of the
test article.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
- 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'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The results of the Salmonella-Escherichia coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay indicate that under the conditions of this study, the test article did not cause a positive increase in the mean number of revertants per plate with any of the tester strains in either the presence or absence of microsomal enzymes prepared from Aroclor™-induced rat liver (S9). - Executive summary:
The test article was investigated for mutagenic activity in the Salmonella-Escherichia coli/ Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay. This assay evaluated the test article and/or its metabolites for their ability to induce reverse mutations at the histidine locus in the genome of specific Salmonella typhimurium tester strains and at the tryptophan locus in an Escherichia coli tester strain both in the presence and absence of an exogenous metabolic activation system of mammalian microsomal enzymes derived from Aroclor™ 1254 -induced rat liver (S9). The doses tested in the mutagenicity assay were selected based on the results of a dose
rangefinding study using tester strains TA 100 and WP2uvr A(pKM 101) and ten doses of test article ranging from 5,000 to 6.67 ug per plate, one plate per dose, both in the presence and absence of S9 mix. The tester strains used in the mutagenicity assay were Salmonella typhimurium TA 98, TA l00, TA l535, and TA 1537 tester strains and Escherichia coli tester strain WP2uvrA(pKM101). The assay was conducted with five doses of test article in both the presence and absence of S9 mix along with concurrent vehicle and positive controls using three plates per dose. The doses tested were 5,000, 3,330, 1,000, 333, and 100 ug per plate in both the presence and absence of S9 mix. The results of the initial mutagenicity assay were confirmed in an independent experiment.
The results of the Salmonella-Escherichia coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay indicate that under the conditions of this study, n-butyronitrile did not cause a positive increase in the mean number of revertants per plate with any of the tester strains in either the presence or absence of microsomal enzymes prepared from Aroclor™ 1254 -induced rat liver (S9).
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