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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Development and Validation of an Alternative Dermal Sensitization Test: The Mouse Ear Swelling Test (MEST)
Author:
Gad SC, Dunn BJ, Dobbs DW, Reilly C, Walsh RD
Year:
1986
Bibliographic source:
Toxicology and Applied Pharmacology 84: 93-114

Materials and methods

Principles of method if other than guideline:
Guinea pig maximization test
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
At the time (1986) where the testing was performed, the LLNA method was not yet established. Thus only testing in guinea pigs (here: Guinea pig maximization test) was possible.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): butyl acetate
- Analytical purity: at least 98 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Challenge
Route:
epicutaneous, occlusive
Details on study design:
Hartley strain guinea pigs were each given six intradermal injections on the first day of the study. Two injections of each of the following were given : a 50% solution of Butyl Acetate in ethanol, Freund's Complete Adjuvant, and Butyl Acetate in Freund's Complete Adjuvant . After a 7 day nontreatment period, a closed patch application of undiluted Butyl Acetate was applied to the intradermal (i .d.) site skin for 48 h. A challenge application of a closed patch to an untreated site was made 7 days after the induction patch with the undiluted substance and the challenge patch was left on for 24 h.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 15.0.

Applicant's summary and conclusion