Registration Dossier
Registration Dossier
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EC number: 200-893-9 | CAS number: 75-71-8
Eye irritation
Administrative data
- Endpoint:
- eye 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:
- Refer to "details on study design" below.
- 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 / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not specified
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- Not specified
- Duration of treatment / exposure:
- Compounds were applied once a day, 5 days/week for 1 month
- Observation period (in vivo):
- Not specified
- Number of animals or in vitro replicates:
- 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 were applied once a day, 5 days/week for 1 month to the eye of rabbits.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: Not specified
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: No scores specified within the publication
- Irritation parameter:
- iris score
- Basis:
- other: not specified
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: no scores specified within the publication
- Irritation parameter:
- conjunctivae score
- Basis:
- other: not specified
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: no scores specified within the publication
- Irritation parameter:
- chemosis score
- Basis:
- other: not specified
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: no scores specified within the publication
- Irritant / corrosive response data:
- Slight irritation only was noted in the eye of the rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Slight irritation only was noted in the eye of the rabbits.
- 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 were applied once a day, 5 days/week for 1 month to the eye of rabbits.
Slight irritation only was noted in the eye of the rabbits; the effects are not considered to result in classification. The study cites an exposure period of 1 month, 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 eye 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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