Registration Dossier
Registration Dossier
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EC number: 219-834-3 | CAS number: 2549-51-1
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Remarks:
- Specific Target Organ Toxicity following a Single Exposure by Inhalation
- 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:
- The specific target organ toxicity of VCA following a single exposure by inhalation was identified as a potential concern because of the hazardous properties of its degradation products.
Data source
Materials and methods
Test guideline
- 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
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- The specific target organ toxicity of the registered substance following an exposure by inhalation is expected to be driven by the toxicity of degradation products acetaldehyde and chloroacetic acid. Both degradation products are classified as STOT SE 3; H335 (May cause respiratory irritation) based on available data. It is therefore proposed to classify VCA as STOT SE 3; H335 based on the classification of its degradation products acetaldehyde and chloroacetic acid.
- Executive summary:
The specific target organ toxicity of VCA following a single exposure by inhalation was assessed based on the toxicokinetics behaviour of the substance and the available information on its degradation products, acetaldehyde and chloroacetic acid.
Acetaldehyde was shown to induce respiratory irritation in animals and received a Harmonised Classification as STOT SE 3; H335 (May cause respiratory irritation).
Chloroacetic acid was shown to induce respiratory irritation in animals and received a Harmonised Classification as STOT SE 3; H335 (May cause respiratory irritation). This is supported by available results on humans.
While there is no data available indicating that acetaldehyde and chloroacetic acid will be released following an exposure to VCA by inhalation, this mechanism cannot be excluded. It is therefore proposed to classify VCA as STOT SE 3; H335 (May cause respiratory irritation) based on the classification of its degradation products chloroacetic acid and acetaldehyde.
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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