Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Intradermal injections: 5, 2.5, 1, 0.5, 0.25 and 0.1 w/v in suspension in paraffin oil
Sensitisation Phase (topical application): 25% in paraffin oil
Challenge (topical application): 25% in paraffin oil
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
paraffin oil
Concentration / amount:
Intradermal injections: 5, 2.5, 1, 0.5, 0.25 and 0.1 w/v in suspension in paraffin oil
Sensitisation Phase (topical application): 25% in paraffin oil
Challenge (topical application): 25% in paraffin oil
No. of animals per dose:
Preliminary study: 6 males.
Main study: treated group of 10 males and a negative control group of 5 males.
Positive control group: 5 males.

Results and discussion

Any other information on results incl. tables

No irritation reaction was noted at times 24 and 458 hours in animals of the negative control group, and in animals treated during the challenge phase with the test substance at the maximum non irritant concentration.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance is free of any sensitising capacity in the male Guinea pig.