Chlorodifluoromethane

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to Regulation (EC) No. 440/2008 Method B.6 - Skin sensitisation - with modification as original method is not applicable to gaseous substances.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

gaseous substance applied by polypropylene capsule

Principles of method if other than guideline:

The skin sensitisation potential of chlorodifluoromethane was carried out in guinea pigs using
a technique derived from the Magnusson and Kligman maximisation test (Gonnet and Guillot,
1986).
During the induction period the test compound was applied in liquefied conditions under a polypropylene capsule for 48 at the dose of 0.5 ml. At challenge the test compound was applied in the same condition at the dose of 0.25 ml. No vehicle was used. Macroscopic and histological evaluation of skin reaction was scored up to 48 hours after removal of the occlusive capsule.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

Chlorodifluoromethane

EC Number:

200-871-9

EC Name:

Chlorodifluoromethane

Cas Number:

75-45-6

Molecular formula:

CHClF2

IUPAC Name:

chlorodifluoromethane

Details on test material:

During the induction period the test compound was applied in liquefied conditions under a polypropylene capsule for 48 at the dose of 0.5 ml. At challenge the test compound was applied in the same condition at the dose of 0.25 ml. No vehicle was used.

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

Information not available

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Remarks:

gaseous subsance applied contained in polypropylene capsule

Induction 2

Concentration / amount:

Induction period: 0.5 ml pure substance (100%)
Challenge period: 0.25 ml pure substance (100%)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Remarks:

gaseous subsance applied contained in polypropylene capsule

Challenge 2

Concentration / amount:

Induction period: 0.5 ml pure substance (100%)
Challenge period: 0.25 ml pure substance (100%)

No. of animals per dose:

Information not available

Details on study design:

Information not available

Challenge controls:

Information not available

Positive control substance(s):

not specified

Study design: in vivo (LLNA)

Vehicle:

not specified

Concentration:

no information available

No. of animals per dose:

no information available

Details on study design:

no information available

Positive control substance(s):

not specified

Statistics:

no information available

Results and discussion

Positive control results:

Information not available

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

Information not available

Clinical observations:

Macroscopic and histological evaluation of skin reaction was scored up to 48 hours after removal of the occlusive capsule. Under these experimental conditions, chlorodifluoromethane did not produce any cutaneous sensitising reaction.

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Information not available. Clinical observations: Macroscopic and histological evaluation of skin reaction was scored up to 48 hours after removal of the occlusive capsule. Under these experimental conditions, chlorodifluoromethane did not produce any cutaneous sensitising reaction..

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: none

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Macroscopic and histological evaluation of skin reaction was scored up to 48 hours after removal of the occlusive capsule. Under these experimental conditions, chlorodifluoromethane did not produce any cutaneous sensitising reaction.

Executive summary:

Macroscopic and histological evaluation of skin reaction was scored up to 48 hours after removal of the occlusive capsule. Under these experimental conditions, chlorodifluoromethane did not produce any cutaneous sensitising reaction.