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EC number: 443-050-2 | CAS number: 120903-40-4 PERFLUOROHEXANE NITRILE VINYL ETHER
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
An in vitro Ames assay was conducted with MV5CN. The result of the study was:
Negative with and without metabolic activation (S9 mix) when tested according to OECD 471.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M, Lot 3
- Purity, including information on contaminants, isomers, etc.: 93.8%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: approximately 5°C in a refrigerator, light protected, under nitrogen.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: no data.
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: no data.
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: confirmed over 4 hours in ethanol.
- Reactivity of the test material with the incubation material used (e.g. plastic ware): no data.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): dissolved in ethanol at appropriate concentrations immediately before use.
- Preliminary purification step (if any): no data.
- Final concentration of a dissolved solid, stock liquid or gel: concentrations of: 50, 160, 500, 1600, and 5000 μg/plate.
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle): no data.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Specify the relevant form characteristics if different from those in the starting material, such as state of aggregation, shape of particles or particle size distribution: no data. - Target gene:
- Histidine and tryptophan operons.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
Aroclor-induzierter Rattenleber S9-Mix "english" Aroclor-induced rat-liver S9-mix - Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50, 160, 500, 1600, and 5000 ug/plate.
Concentration range in the main test (without metabolic activation): 50, 160, 500, 1600, and 5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-aminoanthracene for all strains with S9
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate) : triplicate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): No data.
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: no data.
- Exposure duration/duration of treatment: 48 hours.
FOR GENE MUTATION:
- Expression time (cells in growth medium between treatment and selection): 48 hours
- Selection time (if incubation with a selective agent): 48 hours - Rationale for test conditions:
- Per OECD 471.
- Evaluation criteria:
- The assay is considered valid if the following criteria are met:
- The solvent control data are within the lab's normal control range for spontaneous mutant frequency
- The positive controls induce increases in the mutation frequency which are significant and within the laboratory's normal range.
Criteria for a positive response:
A test criteria is considered mutagenic if it has either of the following effects:
- It produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn.
- It produces a dose-related increase in the mean number of revertants per plate in at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn.
If the test substance does not achieve either of the above criteria, it is considered to show no mutagenic activity in this system. - Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- 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
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH: No data.
- Data on osmolality: No data.
- Possibility of evaporation from medium: Not expected based on vapor pressure and boiling point.
Ames test:
- Signs of toxicity : none observed.
- Individual plate counts : counted following 48 hour exposure.
- Mean number of revertant colonies per plate and standard deviation : revertant colonies were comparable to solvent controls at all exposure level. Standard deviation were within historical control ranges. - Conclusions:
- Based on the results of the test, MV5CN is not mutagenic in an Ames assay with and without metabolic activation (S9).
- Executive summary:
The mutagenic potential of MV5CN was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA 102, TA1535 and TA1537 in both the presence and absence of a metabolic activation system (S9-mix: Aroclor 1254-induced rat liver). This study was performed in compliance with OECD GLP (1999). The test method was based on OECD 471 (1997), U.S. EPA OPPTS 870.5100 (1998), and EC Directive 2000/32/EC, L136, Annex 4D, Part B 13/14. Two independent mutagenicity studies were conducted (first plate incorporation test with 10% and second plate incorporation test with 30% S9-mix), each in the absence and presence of a metabolizing system. For both studies, MV5CN was dissolved in ethanol. The concentrations used for the first plate incorporation test (10% S9-mix) were 50, 160, 500, 1600, and 5000 ug per plate. The test compound did not precipitate on the plates up to the highest investigated dose of 5000 ug/plate. Because of toxicity in the first plate incorporation test, dose levels from 5 to 5000 ug/plate were chosen for the second plate incorporation test (30% S9-mix). Strain-specific positive controls were included in all tests. All criteria for a valid study were met as described in the protocol. No increase in revertant colonies was observed in either the presence or absence of S9-mix for any strain at any concentration. Under the conditions of this study, MV5CN was not mutagenic in the Bacterial Reverse Mutation Assay in either the presence or absence of metabolic activation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
MV5CN was negative in an Ames assay in the presence and absence of metabolic activation.
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