Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable study; meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Principles of method if other than guideline:
The Guinea pig maximization test. Curr. Probl. Derm. 14, 59-106 (Karger, Basel)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performance before finalization of OECD guideline for LLNA.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal 8% and epicutan 25%
Vehicle:
olive oil
Concentration / amount:
Challenge concentrations with batch 1: 20, 10 and 5%
Challenge concentrations with bacth 2: 10, 5 and 1%
Challenge
Concentration / amount:
Challenge concentrations with batch 1: 20, 10 and 5%
Challenge concentrations with bacth 2: 10, 5 and 1%
No. of animals per dose:
20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: challenge (batch 1)
Hours after challenge:
24
Group:
test group
Dose level:
20%
No. with + reactions:
5
Total no. in group:
25
Remarks on result:
other: Reading:
Reading:
other: challenge (batch 2)
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
other: one batch showed a sensitization effect