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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
1999
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
The study was disregarded since positive reactions observed could have been caused by cross reactions with Isoeugenol.

Data source

Reference
Reference Type:
publication
Title:
Isoeugenol is an important contact allergen: can it be safely replaced with isoeugenyl acetate?
Author:
White IR1, Johansen JD, Arnau EG, Lepoittevin JP, Rastogi S, Bruze M, Andersen KE, Frosch PJ, Goossens A and Menné T.
Year:
1999
Bibliographic source:
Contact Dermatitis. 41(5):272-275.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
155 consecutive subjects were patch tested to isoeugenyl acetate and skin reactions were evaluated.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 155
Clinical history:
None
Controls:
None
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Test item was applied under Finn Chambers (using filter paper discs for the ethanol dilutions)
- Vehicle / solvent: Ethanol
- Concentrations: 0.13, 0.4 and 1.2% in ethanol
- Testing/scoring schedule: Skin reactions were scored on Day 2 and 4 after 2 days occlusion.

EXAMINATIONS
- Grading/Scoring system: Standard international method of recording was used.

Results and discussion

Results of examinations:
NO. OF PERSONS WITH REACTIONS
- 12 individuals showed a reaction. 6 (3.9%) had an allergic reaction to 1.2% isoeugenyl acetate at Day 4. The reactions to the other 2 dilutions tended to be graded. However the positive reactions observed could have been caused by cross reactions with Isoeugenol.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
The study was disregarded since positive reactions observed could have been caused by cross reactions with Isoeugenol.
Executive summary:

In a patch test, 155 consecutive subjects were patch tested to isoeugenyl acetate (0.13, 0.4 and 1.2% in ethanol) under occlusive patch. Two days after application, skin reactions were scored on Day 2 and 4.

 

12 individuals showed a reaction. 6 (3.9%) had an allergic reaction to 1.2% isoeugenyl acetate at Day 4. The reactions to the other 2 dilutions tended to be graded. However the positive reactions observed could have been caused by cross reactions with Isoeugenol.

 

The study was disregarded since positive reactions observed could have been caused by cross reactions with Isoeugenol.