Registration Dossier

Administrative data

Description of key information

Skin and eye irritation are discussed.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Qualifier:
no guideline followed
Principles of method if other than guideline:
See below under "details on study design".
GLP compliance:
not specified
Species:
rat
Strain:
not specified
Details on test animals and environmental conditions:
Not specified
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Refer to "details on study design" below.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified
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.
Irritation parameter:
other: Not specified
Basis:
other: Not specified
Time point:
other: Not specified
Reversibility:
not specified
Remarks on result:
other: No scores specified within the publication
Irritant / corrosive response data:
Slight irritation was noted only in the eye of the rabbits.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight irritation was noted only 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 was noted only 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Data is available on the above endpoints and gave the following results:

 

Skin irritation

A single data source is available; this gave only a slight irritant value.

 

Slight irritation was noted only in the skin of the rat; 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.

Eye irritation

 

Two data sources are available; this gave only a slight irritant value.

 

Slight irritation was noted only in the eye of the rabbits; the effects are not considered to result in classification. The study cites an exposure period of 1 moth, which is above the specified exposure time requirements of the current guidelines. Hence the results are deemed to be appropriate.

CFC-12 has very little toxicity to the eye inside or outside. A bubble of the gas injected into the anterior chamber of rabbit eyes has not proved damaging to the cornea. Exposure of a rabbit eye to pure CFC-12 gas at room temperature for one and one-half minutes induced a slight irregularity of the corneal epithelium, but the eye was completely normal the next day.

 

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.


Justification for selection of skin irritation / corrosion endpoint:
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 tie 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.

Justification for selection of eye irritation endpoint:
Slight irritation was noted only 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.

Justification for classification or non-classification

The above studies have all been ranked reliability 2 according to the Klimish et al system. This ranking was deemed appropriate because the studies were not conducted to GLP and are not in compliance with agreed protocols. However, sufficient dose ranges and numbers are detailed and the results are comparable with each other. As such, it is deemed appropriate to apply a weight of evidence approach based on similarity and animal welfare grounds.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for irritation effects is therefore required.