Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Registrant have not seen the actual study report, but dataholder is reliable

Data source

Reference
Reference Type:
other: email correspondence with dataholder/owner
Title:
No information

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: Intradermal and topical
Vehicle:
propylene glycol
Concentration / amount:
5 % (intradermal) and 6 % (topical) induction, 1 % and 0.5 % in challenge
Challengeopen allclose all
Route:
other: not known but likely intradermal and topical
Vehicle:
propylene glycol
Concentration / amount:
5 % (intradermal) and 6 % (topical) induction, 1 % and 0.5 % in challenge
Positive control substance(s):
not specified

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance has distinct skin sensisation potential under the test conditions of the maximization test