Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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:
1965

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
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Not specified

Test animals

Species:
rat
Strain:
not specified
Details on test animals 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

Results
Irritation parameter:
other: Not specified
Basis:
other: Not specified
Time point:
other: Not specified
Reversibility:
no data
Remarks on result:
other: Not scores specified in the publication
Irritant / corrosive response data:
Slight irritation was noted only in the skin of the rats.
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Does not result in classification. Criteria used for interpretation of results: EU
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.

 

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.