Registration Dossier
Registration Dossier
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EC number: 200-893-9 | CAS number: 75-71-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Taken from publically available data, and is considered accurate based on the registrants experience of the substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 965
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- See below under "details on study design".
- GLP compliance:
- not specified
Test material
- Reference substance name:
- CFC-12
- IUPAC Name:
- CFC-12
- Test material form:
- not specified
- Details on test material:
- Not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Not specified
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- Not specified
- Duration of treatment / exposure:
- 1-2 times/day, 5 days/week, for 5-6 weeks
- Observation period:
- Not specified
- Number of animals:
- Not specified
- Details on study design:
- Quevauviller et al. (1964) and Quevauviller (1965) applied CFC-11, CFC-12, CFC-114, and mixtures of CFC-11 and CFC-12 and of CFC-11 and CFC-22 to the skin, tongue, soft palate, and auditory canal of rats, 1-2 times/day, 5 days/week, for 5-6 weeks.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: Not specified
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No scores specified in the publication
- Irritation parameter:
- edema score
- Basis:
- other: not specified
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: no scores specified in the publication
- Irritant / corrosive response data:
- Only slight irritation was noted on the skin of the rats.
- Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Slight irritation was noted only in the skin of the rats; the effects are not considered to result in classification. The study cites an exposure period of some 5 to 6 weeks, which is above the specified exposure time requirements of the current guidelines. Hence the results are deemed to be appropriate.
It should be noted that the substance is a gas, and as such, prolonged exposure to the skin is not anticipated. Following exposure, evaporation would occur, resulting in rapid removal from the site, hence minimising the effects of acute exposure.
It should also be noted that in accordance with section 2 of REACH Annex XI, the study does not need to be conducted as the substance is a gas. Hence the data provided is considered appropriate for assessment of this endpoint as supporting information only. - Executive summary:
Quevauviller et al. (1964) and Quevauviller (1965) applied CFC-11, CFC-12, CFC-114, and mixtures of CFC-11 and CFC-12 and of CFC-11 and CFC-22 to the skin, tongue, soft palate, and auditory canal of rats, 1-2 times/day, 5days/week, for 5-6weeks.
Only slight irritation was noted on the skin of the rats; the effects are not considered to result in classification. The study cites an exposure period of some 5 to 6 weeks, which is above the specified exposure time requirements of the current guidelines. Hence the results are deemed to be appropriate.
It should be noted that the substance is a gas, and as such, prolonged exposure to the skin is not anticipated. Following exposure, evaporation would occur, resulting in rapid removal from the site, hence minimising the effects of acute exposure.
It should also be noted that in accordance with section 2 of REACH Annex XI, the study does not need to be conducted as the substance is a gas. Hence the data provided is considered appropriate for assessment of this endpoint as supporting information only.
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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