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Diss Factsheets
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EC number: 200-832-6 | CAS number: 75-02-5
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 0.063 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 1
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The DMEL worker long-term inhalation exposure is derived as follows:
This is a volatile substance and potential worker population exposure would likely occur via the inhalation route. VF is considered to be a likely non-threshold genotoxic carcinogen in humans. No local effects were observed in acute or repeated exposure studies; therefore no DNEL for local effects was derived.
Discussion:
Per Appendix R.8-13 of the Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health (May 2008, ECHA), an EU IOEL may used in place of developing a DNEL (DMEL). In this case, the substance, vinyl fluoride (VF), is biotransformed by the same metabolic pathway as an extensively studied known human carcinogen, vinyl chloride (VC). The biotransformation proceeds via the cytochrome P450 (CYP) 2E1 pathway, and is followed by interaction with DNA. VC is associated with a very rare angiosarcoma cancer type in humans and cancer in laboratory animals. VF is likewise associated with cancer in laboratory animals. The production of cancer is related to the VC and VF biotransformation products. The biotransformation pathway becomes saturated at concentrations above 75 ppm VF and 250 ppm VC. While VC is biotransformed at a faster rate and to a greater extent than VF, the close structural and chemical similarity as well as behaviour in biological systems allows for the use of VC (human data and analysis) as a conservative read-across substance in the assessment of VF carcinogenicity. See additional supporting documentation (analogue reporting format) attached in IUCLID5.
The SCOEL has performed an assessment of human risk of carcinogenicity of VC related to workplace conditions (SCOEL, 2002). Toxicology and carcinogenicity of VC have been widely studied during the last 25 years, and a number of assessments of carcinogenic risk have been carried out, based on both occupational epidemiology and animal experimental data. The established carcinogenicity is the main toxicological effect of the substance. VC is classified as a human carcinogen by the European Union (EU) (category l) and the International Agency for Research on Cancer (IARC) (group l). As a first step, available data were reviewed which indicated that a linear high dose – low dose extrapolation of tumour risk was appropriate in this case. On this basis, the available quantitative risk assessments were reviewed, including those based on human epidemiological data, and those based on extrapolation from animal data via PBPK modelling. The different approaches resulted in final risk estimates which were reasonably consistent with each other. Based on the robust VC dataset, it was concluded that continuous exposure throughout a working life to 1 ppm VC would be associated with a cancer risk for hepatic angiosarcoma of 0.3E-3. The derivation procedures for calculating these risk estimates are in line with the approach for deriving a DMEL outlined under REACH. The highly conservative nature of the linear extrapolation approach mitigates the need for additional application of assessment factors for intra- or interspecies differences.
A credible case could be made that based on kinetic information. VF has about 3 times less carcinogenic potential than VC. However, to provide an extra margin of safety, the SCOEL VC risk estimate was directly applied to VF.
Using the risk estimate slope for VC and converting to mg/m3, the long-term worker inhalation DMEL is 0.063 mg/m3.
As a point of reference, the DMEL is considerably lower than safe worker numbers established via other organizations. Multiple countries, including, Canada, United States, and Ireland, have a safe workplace exposure guidance value of 1 ppm 8-hour TWA to protect workers from adverse VF effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 0.005 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 2
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The DMEL general population long-term inhalation exposure is derived as follows:
This is a volatile substance and potential general population exposure would likely occur via the inhalation route. VF is considered to be a likely non-threshold genotoxic carcinogen in humans. No local effects were observed in acute or repeated exposure studies; therefore no DNEL for local effects was derived.
Discussion:
Per Appendix R.8-13 of the Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health (May 2008, ECHA), an EU IOEL may used in place of developing a DNEL (DMEL). In this case, the substance, vinyl fluoride (VF), is biotransformed by the same metabolic pathway as an extensively studied known human carcinogen, vinyl chloride (VC). The biotransformation proceeds via the cytochrome P450 (CYP) 2E1 pathway, and is followed by interaction with DNA. VC is associated with a very rare angiosarcoma cancer type in humans and cancer in laboratory animals. VF is likewise associated with cancer in laboratory animals. The production of cancer is related to the VC and VF biotransformation products. The biotransformation pathway becomes saturated at concentrations above 75 ppm VF and 250 ppm VC. While VC is biotransformed at a faster rate and to a greater extent than VF, the close structural and chemical similarity as well as behaviour in biological systems allows for the use of VC (human data and analysis) as a conservative read-across substance in the assessment of VF carcinogenicity. See additional supporting documentation (analogue reporting format) attached in IUCLID5.
The SCOEL has performed an assessment of human risk of carcinogenicity of VC related to workplace conditions (SCOEL, 2002). Toxicology and carcinogenicity of VC have been widely studied during the last 25 years, and a number of assessments of carcinogenic risk have been carried out, based on both occupational epidemiology and animal experimental data. The established carcinogenicity is the main toxicological effect of the substance. VC is classified as a human carcinogen by the European Union (EU) (category l) and the International Agency for Research on Cancer (IARC) (group l). As a first step, available data were reviewed which indicated that a linear high dose – low dose extrapolation of tumour risk was appropriate in this case. On this basis, the available quantitative risk assessments were reviewed, including those based on human epidemiological data, and those based on extrapolation from animal data via PBPK modelling. The different approaches resulted in final risk estimates which were reasonably consistent with each other. Based on the robust VC dataset, it was concluded that continuous exposure throughout a working life to 1 ppm VC would be associated with a cancer risk for hepatic angiosarcoma of 0.3E-3 . The derivation procedures for calculating these risk estimates are in line with the approach for deriving a DMEL outlined under REACH, The highly conservative nature of the linear extrapolation approach mitigates the need for additional application of assessment factors for intra or interspecies differences in the worker population. However a couple of assessment factors are appropriate for the general population. The human risk assessments were done in worker populations, therefore, per REACH guidance, an assessment factor of 2 should be applied to account for greater susceptibility in the general population. Further, for the purposes of the DMEL, the general population is assumed to have a continuous lifetime exposure. As a result, an assessment factor of 7 should be applied to adjust from a working lifetime to a whole lifetime, as described in the SCOEL document.
Using the risk estimate slope for VC and converting to mg/m3, the long-term inhalation general population DMEL is 0.005 mg/m3.
0.063 mg/m3/ 2 / 7 = 0.0045 mg/m3 (rounded to 0.005 mg/m3)
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.
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