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Diss Factsheets
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EC number: 219-834-3 | CAS number: 2549-51-1
- 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
Description of key information
The toxicity of VCA following short-term repeated oral exposure was assessed based on the toxicokinetics behaviour of the substance and the available information on the repeated-dose toxicity of its degradation products acetaldehyde and chloroacetic acid.
The short-term repeated dose toxicity of acetaldehyde by the oral route was investigated and allowed to derive a NOAEL of 125 mg/kg bw/d (equivalent to an ingestion of 341.25 mg/kg bw/d of VCA).
The repeated dose toxicity of chloroacetic acid by the oral route was investigated and a NOAEL of 3.5 mg/kg bw/d (equivalent to an ingestion of 4.48 mg/kg bw/d mg/kg bw/d of VCA) from a chronic toxicity study was identified. This value is considered as conservative in order to assess the short-term (4 weeks) repeated dose toxicity of VCA.
It can be expected from these results that the short-term repeated-dose toxicity of VCA following an oral exposure will be driven by its degradation product chloroacetic acid as it was shown to be more hazardous than acetaldehyde following a repeated exposure. Therefore the NOAEL of 4.48 mg/kg bw/d derived from a chronic toxicity study shall be used for the short-term repeated-dose toxicity of VCA. This value is conservative and considered to cover the adverse effects induced by the two main degradation products of VCA.
In accordance with Annex VIII of REACH, Column 2, testing by the inhalation and dermal routes is only appropriate if exposure of humans via these routes is likely. Vinyl Chloroacetate is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via the dermal and inhalation routes is expected.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- other: Expert assessment
- Adequacy of study:
- weight of evidence
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Expert assessment based on literature data on the degradation products of VCA
- Justification for type of information:
- An experimental study to determine the toxicity of VCA following a repeated oral exposure was not considered necessary, nor scientifically justified, since the registered substance is expected to undergo rapid degradation following an oral exposure. Therefore this assessment was based on the degradation products of VCA.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Expert assessment based on literature data on the degradation products of VCA
- GLP compliance:
- no
- Limit test:
- no
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 4.48 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- Critical effects observed:
- no
- Conclusions:
- The short-term repeated-dose toxicity of VCA following an oral exposure is expected to be driven by its degradation product chloroacetic acid as it was shown to be more hazardous than acetaldehyde following a repeated exposure by the oral route. Therefore the NOAEL of 4.48 mg/kg bw/d derived from a chronic toxicity study shall be used for the short-term repeated-dose toxicity of VCA. This value is conservative and considered to cover the adverse effects induced by the two main degradation products of VCA.
- Executive summary:
The toxicity of VCA following short-term repeated oral exposure was assessed based on the toxicokinetics behaviour of the substance and the available information on the repeated-dose toxicity of its degradation products acetaldehyde and chloroacetic acid.
The short-term repeated dose toxicity of acetaldehyde by the oral route was investigated and allowed to derive a NOAEL of 125 mg/kg bw/d (equivalent to an ingestion of 341.25 mg/kg bw/d of VCA). The
The repeated dose toxicity of chloroacetic acid by the oral route was investigated and a NOAEL of 3.5 mg/kg bw/d (equivalent to an ingestion of 4.48 mg/kg bw/d mg/kg bw/d of VCA) from a chronic toxicity study was identified. This value is considered as conservative in order to assess the short-term (4 weeks) repeated dose toxicity of VCA.
It can be expected from these results that the short-term repeated-dose toxicity of VCA following an oral exposure will be driven by its degradation product chloroacetic acid as it was shown to be more hazardous than acetaldehyde following a repeated exposure. Therefore the NOAEL of 4.48 mg/kg bw/d derived from a chronic toxicity study shall be used for the short-term repeated-dose toxicity of VCA. This value is conservative and considered to cover the adverse effects induced by the two main degradation products of VCA.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 4.48 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Expert assessment based on literature data on the degradation products of VCA
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII of REACH, Column 2, testing by inhalation route is appropriate if exposure of humans via inhalation is likely. Vinyl Chloroacetate is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via inhalation is expected.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII of REACH, Column 2, testing by inhalation route is appropriate if exposure of humans via inhalation is likely. Vinyl Chloroacetate is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via inhalation is expected.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII of REACH, Column 2, testing by the dermal route is appropriate if exposure of humans via this route is likely. Vinyl Chloroacetate is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via the dermal route is expected.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII of REACH, Column 2, testing by the dermal route is appropriate if exposure of humans via this route is likely. Vinyl Chloroacetate is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via the dermal route is expected.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
VCA is expected to degrade rapidly following an oral exposure. The toxicity of VCA following short-term repeated oral exposure was therefore assessed based on the available information on the repeated-dose toxicity of its degradation products acetaldehyde and chloroacetic acid. None of these degradation products are classified as toxic to specific target organs following a repeated exposure based on the available information of these substances. As a result VCA shall not be classified as toxic to specific target organs.
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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