Dichlorodifluoromethane

Sensitisation data (human)

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:

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:

Not specified

Author:

Van Ketel

Year:

1976

Bibliographic source:

WHO: Enviromental Health Criteria 113: Fully Halogenated Chlorofluorocarbons, 1990

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

Test material information

Constituent 1

Reference substance name:

CFC-12

IUPAC Name:

CFC-12

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 to deodorant sprays

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 reactions 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 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.

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.