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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No deviation from OECD-406 guideline, not GLP, but competent authorities agency accreditation of the lab.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Remarks:
but competent authorities agency accreditation of the lab.
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed before the validation of the LLNA method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal = 5%, 2.5%, 1.25% and 0.625%
Epicutaneous = 50% and 25%
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal = 5%, 2.5%, 1.25% and 0.625%
Epicutaneous = 50% and 25%
No. of animals per dose:
2 animals / intradermal
20 animals / epicutaneous + 10 animals as vehicle control

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Light erythema, fully reversible at 72 hours.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Light erythema, fully reversible at 72 hours..

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
APP-6669 is not sensitising according to OECD-406 test.