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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
publication
Title:
Development and Validation of an Alternative Dermal Sensitization Test : The Mouse Ear Swelling Test (MEST)
Author:
Gad S.C., Dunn B.J., Dobbs D.W., Reilly C., Walsh R.D.
Year:
1986
Bibliographic source:
Toxicol. Appl. Pharmacol. 84, 93-114.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
existing study available from publication

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: intradermal and epicutaneous occlusive
Vehicle:
not specified
Concentration / amount:
100%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
100%
No. of animals per dose:
Test group: 15
control group: 6
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
no data
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no data
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
15
Total no. in group:
15
Clinical observations:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met