Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1979

Materials and methods

Type of study / information:
Skin irritation
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
A panel of 50 adult male volunteers were dermally exposed to the test material, under a patch, for 48 h and then scored for irritation reactions.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Storage condition of test material: Kept in light-intercepting ampoule at 5 °C.

Method

Ethical approval:
not applicable
Details on study design:
- A panel of 50 adult male volunteers was dermally exposed to 0.05 mL of Iso-eugenol (32 % in acetone) under a 15 mm lint patch.
- Individuals with known allergic reactions were excluded.
- Patches were placed in contact with the skin on the back of each subject and left for 48 h. The patches were then removed and the sites were swabbed with dry gauze to remove any residual test materials. 30 minutes later, the test sites were evaluated for dermal reactions. If necessary, 72, 96 and 120 h readings were performed.

- Scoring of patch test reactions:
-: negative reading
±: questionable erythema not covering the entire patch area
+: definite erythema of the entire patch area
++: erythema and edema
+++: erythema, edema, and vesicles (or papules)
++++: bullous reaction
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: Under occlusive patches

EXPOSURE LEVELS: 0.05 mL of Iso-eugenol (32 % in acetone) under a 15 mm lint patch

EXPOSURE PERIOD: 48h

POSTEXPOSURE PERIOD: The patches were then removed and the sites were swabbed with dry gauze to remove any residual test materials

Results and discussion

Results:
Iso-eugenol induced moderate skin irritation in human and the irritation score was 2.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
In humans, a solution of 32% Isoeugenol in acetone was found to be moderately irritating when applied to the skin of 50 adult males in occlusive patches over 48 hours
Executive summary:

In a dermal irritation study, a panel of 50 adult male volunteers was dermally exposed to 0.05 mL of Iso-eugenol (32 % in acetone) under a 15 mm lint patch. Individuals with known allergic reactions were excluded. The patches were placed in contact with the skin on the back of each subject and left for 48 h. The patches were then removed and the sites were swabbed with dry gauze to remove any residual test materials. 30 minutes later, the test sites were evaluated for dermal reactions. If necessary, 72, 96 and 120 h readings were performed.

Iso-eugenol induced moderate skin irritation in human and the irritation score was 2.

In humans, the solution of 32% Isoeugenol in acetone was found to be moderately irritating when applied to the skin of 50 adult males in occlusive patches over 48 hours