Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 207-306-5 | CAS number: 460-19-5
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Mouse lymphoma assay
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: Mouse Lymphoma Assay
Test material
- Reference substance name:
- Oxalonitrile
- EC Number:
- 207-306-5
- EC Name:
- Oxalonitrile
- Cas Number:
- 460-19-5
- Molecular formula:
- C2N2
- IUPAC Name:
- carbononitridic cyanide
- Test material form:
- gas
Constituent 1
- Specific details on test material used for the study:
- Lot/Batch number 14/07
Purity in accordance with 5-batch analysis
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Remarks:
- subline 3.7.2c
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Concentration of test substance
Preliminary toxicity test: 0.01, 0.02, 0.039, 0.078, 0.156, 0.3125, 0.625, 1.25, 2.5 and 5% v/v
Mutation tests:
-S9 mix (3 hours) 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.4 and 0.5 % v/v
+S9 mix (3 hours) 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.75 and 1 % v/v
-S9 mix (24 hours) 0.003, 0.006, 0.0125, 0.025, 0.05, 0.1, 0.15 % v/v
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Details on test system and experimental conditions:
- Way of application
The cultures, containing S9 mix where appropriate, were transferred to 25 cm2 flasks. The vessels were sealed and partially evacuated. Appropriate volumes of the test substance were injected via a valve to produce atmospheres at the required concentrations. The vessels were warmed to 37°C and the contents equilibrated to atmospheric pressure, where necessary, by admitting sterile atmospheric air.
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- at cytotoxic concentrations
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Results and Discussion
Genotoxicity
Without metabolic activation
Main Mutation Test – 3-hour Treatment in the Absence of S9 Mix
There were increases in the mean mutant frequency of the cells when exposed to Ethanedinitrile at 0.4 and 0.5% v/v that exceeded the sum of the mean concurrent vehicle control mutant frequency plus the Global Evaluation Factor (GEF), within acceptable levels of toxicity.
The increases in mean mutant frequency were predominantly due to increased small colony formation when compared to the concurrent vehicle control, which, according to current opinion, suggests large DNA events such as the loss of whole chromosomes, translocations, transversions and large deletions, but not point mutations.
Main Mutation Test – 24-hour Treatment in the Absence of S9 Mix
Cultures were exposed to Ethanedinitrile at concentrations from 0.003 to 0.1% v/v. No precipitate was observed by eye at the end of treatment. Cultures exposed to Ethanedinitrile at concentrations from 0.0125 to 0.15% v/v were assessed for determination of mutation frequency. RTG values from 116 to 25% were obtained relative to the vehicle control. There were increases in the mean mutant frequency of the cells when exposed to Ethanedinitrile at 0.15% v/v that exceeded the sum of the mean concurrent vehicle control mutant frequency plus the Global Evaluation Factor (GEF), within acceptable levels of toxicity. A concentration response relationship was observed across all concentrations (p<0.001). The increases in mean mutant frequency were predominantly due to increased small colony formation when compared to the concurrent vehicle control, which, according to current opinion, suggests large DNA events such as the loss of whole chromosomes, translocations, transversions and large deletions, but not point mutations.
With metabolic activation
Main Mutation Test – 3-hour Treatment in the Presence of S9 Mix
There were increases in the mean mutant frequency of the cells when exposed to Ethanedinitrile at 1 % v/v that exceeded the sum of the mean concurrent vehicle control mutant frequency plus the Global Evaluation Factor (GEF), within acceptable levels of toxicity.
The increases in mean mutant frequency was predominantly due to increased small colony formation when compared to the concurrent vehicle control, which, according to current opinion, suggests large DNA events such as the loss of whole chromosomes translocations, transversions and large deletions, but not point mutations.
Cytotoxicity
No precipitate (observed by eye at the end of treatment) was observed at any concentrations of Ethanedinitrile tested in the absence and presence of S9 mix, following a 3-hour exposure. Exposure to Ethanedinitrile at concentrations from 0.01 to 5% v/v in the absence and presence of S9 mix resulted in relative suspension growth (RSG) values from 93 to 2% and from 108 to 2% respectively. Following a continuous exposure for 24 hours, no precipitation (assessed by eye at the end of treatment) was observed at any concentrations of Ethanedinitrile tested. Exposure to concentrations from 0.01 to 5% v/v resulted in RSG values from 63 to 0%. Concentrations used in the main test were based upon these data.
Applicant's summary and conclusion
- Conclusions:
- It was concluded that Ethanedinitrile demonstrated mutagenic potential in this in vitro cell mutation assay, under the experimental conditions described. The maximum concentrations tested were limited by toxicity to 0.5 and 1% v/v, with the RTG being reduced to 22 and 16% for the 3-hour treatments in the absence and presence of S9 mix, respectively.
The increases in mean mutant frequency that exceeded the sum of the mean concurrent vehicle control mutant frequency and the Global Evaluation Factor (GEF) were associated with decreases in RTG (measurement of toxicity). - Executive summary:
Materials and Methods
Test material
Ethanedinitrile (Oxalonitrile)
Lot/Batch number
14/07
Specification
Specification in accordance with 5-batch analysis, see certificate of analysis within the study
Description
Colorless gas
Purity
Purity in accordance with 5 batch analysis, see certificate of analysis within the study
Stability
1 year
Study Type
Mouse Lymphoma Assay
Organism/cell type
Subline 3.7.2c of mouse lymphoma L5178Y cells
Metabolic activation system
S9 mix from rats treated with phenobarbital and 5,6-benzoflavone
Positive control
Yes
Administration/Exposure
Concentration of test substance
Preliminary toxicity test: 0.01, 0.02, 0.039, 0.078, 0.156, 0.3125, 0.625, 1.25, 2.5 and 5% v/v
Mutation tests:
-S9 mix (3 hours) 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.4 and 0.5 % v/v
+S9 mix (3 hours) 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.75 and 1 % v/v
-S9 mix (24 hours) 0.003, 0.006, 0.0125, 0.025, 0.05, 0.1, 0.15 % v/v
Way of application
The cultures, containing S9 mix where appropriate, were transferred to 25 cm2flasks. The vessels were sealed and partially evacuated. Appropriate volumes of the test substance were injected via a valve to produce atmospheres at the required concentrations. The vessels were warmed to 37°C and the contents equilibrated to atmospheric pressure, where necessary, by admitting sterile atmospheric air.
Results and Discussion
Genotoxicity
Without metabolic activation
Main Mutation Test–3-hour Treatment in the Absence of S9 Mix
There were increases in the mean mutant frequency of the cells when exposed to Ethanedinitrile at 0.4 and 0.5% v/v that exceeded
the sum of the mean concurrent vehicle control mutant frequency plus the Global Evaluation Factor (GEF), within acceptable levels of toxicity.The increases in mean mutant frequency were predominantly due to increased small colony formation when compared to the
concurrent vehicle control, which, according to current opinion, suggests large DNA events such as the loss of whole chromosomes,
translocations, transversions and large deletions, but not point mutation.
.Main Mutation Test–24-hour Treatment in the Absence of S9 Mix
Cultures were exposed to Ethanedinitrile at concentrations from 0.003 to 0.1% v/v. No precipitate was observed by eye at the end
of treatment. Cultures exposed to Ethanedinitrile at concentrations from 0.0125 to 0.15% v/v were assessed for determination of mutation frequency. RTG values from 116 to 25% were obtained relative to the vehicle control. There were increases in the mean mutant frequency of the cells when exposed to Ethanedinitrile at 0.15% v/v that exceeded the sum of the mean concurrent vehiccle control mutant frequency plus the Global Evaluation Factor (GEF), within acceptable levels of toxicity. A concentration response relationship was observed across all concentrations (p<0.001). The increases in mean mutant frequency were predominantly due to increased small colony formation when compared to the concurrent vehicle control, which, according to current opinion, suggests large DNA events such as the loss of whole chromosome translocations, transversions and large deletions, but not point mutations.With metabolic activation
Main Mutation Test–3-hour Treatment in the Presence of S9 Mix
There were increases in the mean mutant frequency of the cells when exposed to Ethanedinitrile at 1 % v/v that exceeded the sum of the mean concurrent vehicle control mutant frequency plus the Global Evaluation Factor (GEF), within acceptable levels of toxicity.
The increases in mean mutant frequency was predominantly due to increased small colony formation when compared to the concurrent vehicle control, which, according to current opinion, suggests large DNA events such as the loss of whole chromosomes
translocations, transversions and large deletions, but not point mutations.Cytotoxicity
No precipitate (observed by eye at the end of treatment) was observed at any concentrations of Ethanedinitrile tested in the
absence and presence of S9 mix, following a 3-hour exposure. Exposure to Ethanedinitrile at concentrations from 0.01 to 5% v/v in the absence and presence of S9 mix resulted in relative suspension growth (RSG) values from 93 to 2% and from 108 to 2% respectively. Following a continuous exposure for 24 hours, no precipitation (assessed by eye at the end of treatment) was observed at any concentrations of Ethanedinitrile tested. Exposure to concentrations from 0.01 to 5% v/v resulted in RSG values from 63 to 0%.
Concentrations used in the main test were based upon these data.Summary and conclusion
Materials and methods
Ethanedinitrile was tested for mutagenic potential in an in vitro mammalian cell mutation assay. This test system is based on detection and quantitation of forward mutation in the subline 3.7.2c of mouse lymphoma L5178Y cells, from the heterozygous condition at the thymidine kinase locus (TK+/-) to the thymidine kinase deficient genotype (TK-/-). The study consisted of a preliminary toxicity test and three independent mutagenicity assays. The cells were exposed for either 3 hours or 24 hours in the absence of exogenous metabolic activation (S9 mix) or 3 hours in the presence of S9 mix. Concentrations of Ethanedinitrile up to 5% v/v were tested. Ethanedinitrile was not tested at greater concentrations than this due to a known explosion hazard. Sterile air was used as a vehicle control.
Results and discussion
Toxicity was observed in the preliminary toxicity test. Following a 3-hour exposure to ethanedinitrile at concentrations from 0.01 to 5% v/v, relative suspension growth (RSG) was reduced from 93 to 2% and from 108 to2% in the absence and presence of S9 mix respectively. Following a 24-hour exposure in the absence of S9 mix RSG was reduced from 63 to 0%. The concentrations assessed for determination of mutant frequency in the main test were based upon these data, the objective being to assess concentrations which span the complete toxicity range of approximately 10 to 100% relative total growth (RTG).
Following 3-hour treatment in the absence of S9 mix, there were increases in mean mutant frequency that exceeded the sum of the mean concurrent vehicle control mutant frequency and the Global Evaluation Factor (GEF) at concentrations of 0.4 and 0.5% v/v, with the RTG being reduced to 45 and 16% respectively. A concentration response relationship was observed across all concentrations (p<0.001).
Following 3-hour treatment in the presence of S9 mix, there was an increase in mean mutant frequency that exceeded the sum of the mean concurrent vehicle control mutant frequency and the Global Evaluation Factor (GEF) at a concentration of 1% v/v, with the RTG being reduced to 22%. A concentration response relationship was observed across all concentrations (p<0.001).
Following 24-hour treatment in the absence of S9 mix, there was an increase in mean mutant frequency that exceeded the sum of the mean concurrent vehicle control mutant frequency and the Global Evaluation Factor (GEF) at a concentration of 0.15% v/v, with the RTG being reduced to 25%. A concentration response relationship was observed across all concentrations (p<0.001).
Conclusion
It was concluded that Ethanedinitrile demonstrated mutagenic potential in this in vitro cell mutation assay, under the experimental conditions described. The maximum concentrations tested were limited by toxicity to 0.5 and 1% v/v, with the RTG being reduced to 22 and 16% for the 3-hour treatments in the absence and presence of S9 mix, respectively.
The increases in mean mutant frequency that exceeded the sum of the mean concurrent vehicle control mutant frequency and the Global Evaluation Factor (GEF) were associated with decreases in RTG (measurement of toxicity).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.