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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
Study period:
March, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Pre-LLNA test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: 'P' strain
Sex:
male/female

Study design: in vivo (non-LLNA)

No. of animals per dose:
10 male, 10 female
Details on study design:
The guinea-pig maximization procedure of Magnusson and Kligman* was used to assess the skin sensitizing potential of the test material.

A preliminary screen was carried out using groups of two male and two female guinea-pigs to determine the concentrations of test material to be used for intradermal induction, topical induction and topical challenge.

In the test itself groups of ten male and ten female guinea-pigs were used with a further five males and five females as controls.
Challenge controls:
5 male, 5 female
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
11
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Based on the number of animals showing a response, the degree of intensity of the response and its persistence, the material is considered to be a moderate skin sensitizer in guinea-pigs.