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Toxicological information

Skin sensitisation

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

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

Constituent 1
Chemical structure
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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
gaseous subsance applied contained in polypropylene capsule
Concentration / amount:
Induction period: 0.5 ml pure substance (100%)
Challenge period: 0.25 ml pure substance (100%)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
gaseous subsance applied contained in polypropylene capsule
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)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: none
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.