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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
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:
1976

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
See "details on study design" below.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
aerosol dispenser: not specified
Remarks:
migrated information: aerosol
Details on test material:
Not specified

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 18
- Sex: Not specified
- Age: Not specified
- Race: Not specified
- Demographic information: Not specified
- Other: N/A
Clinical history:
3 patients with a prior history of skin reactions
Controls:
15 patients with no prior history of skin recations
Route of administration:
dermal
Details on study design:
Van Ketel (1976) reported allergic contact eczema in patch tests performed in three patients that had a prior history of skin recations to deodorant sprays. Fifteen controls (without prior history of allergy to deodorants) were also utilised.

Results and discussion

Results of examinations:
Only one patient showed a mild reaction to CFC-12. Fifteen controls (without prior history of allergy to deodorants) showed no response to CFC-12.

Applicant's summary and conclusion

Conclusions:
The available data indicates that application of CFC-12 to the skin under patch test conditions did not elicit a sensitisation response. Given the nature of CFC-12 as a gas, conditions resulting in prolonged application to the skin are unlikely to allow for elicitation of a sensitisation response. CFC-12 is a controlled substancedue to the participation in the depletion of stratospheric ozone (Montreal Protocol). As a result of this, it is no longer utilised in aerosol sprays, hence repeated exposure is unlikely. In the event of accidental exposure to the skin, rapid volatilisation will result in removal from the affected area, thus reducing the potential to cause sensitisation via prolonged contact. On the basis of the data available, it is concluded that the substance is not a skin sensitiser.
Executive summary:

Van Ketel (1976) reported allergic contact eczema in patch tests performed on three patients that had prior history of skin reactions to deodorant sprays. Only one patient showed a mild reaction to CFC-12. Fifteen controls (without prior history of allergy to deodorants) showed no response to CFC-12.

The available data indicates that application of CFC-12 to the skin under patch test conditions did not elicit a sensitisation response. Given the nature of CFC-12 as a gas, conditions resulting in prolonged application to the skin are unlikely to allow for elicitation of a sensitisation response. CFC-12 is a controlled substance due to the participation in the depletion of stratospheric ozone (Montreal Protocol). As a result of this, it is no longer utilised in aerosol sprays, hence repeated exposure is unlikely. In the event of accidental exposure to the skin, rapid volatilisation will result in removal from the affected area, thus reducing the potential to cause sensitisation via prolonged contact. On the basis of the data available, it is concluded that the substance is not a skin sensitiser.