Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Test method no longer in use, incompletely documented, and no data on purity.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1973
Reference Type:
other: OECD SIDS
Title:
Unnamed
Year:
2001

Materials and methods

Principles of method if other than guideline:
3 drops (10% sol.) were applied to the clipped area of the skin of 10 guinea pigs; on day 22 injection of Freund-adjuvans and test substance into the hind paw (0.5 mg/kg bw) was performed, on day 28 3 drops (10 % sol.)were applied to an untreated clipped area of the skin. The reading times are not mentiond.
GLP compliance:
no
Type of study:
other: modified Freund's complete adjuvant test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: acetone
Concentration / amount:
Induction: 10% (epicutaneous), 0.5 mg/kg bw (intradermal)
Challenge: 10%
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: acetone
Concentration / amount:
Induction: 10% (epicutaneous), 0.5 mg/kg bw (intradermal)
Challenge: 10%
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: reading time not mentioned
Clinical observations:
sensitising
Remarks on result:
other: Reading: other: reading time not mentioned. Clinical observations: sensitising.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information