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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1963
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study with basic documentation which meets basic scientific principles. However, the lack of occlusion for the solvent means that the result cannot be considered reliable as a true indicator of irritation potential.

Data source

Reference
Reference Type:
publication
Title:
Range finding toxicity data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel BS
Year:
1962
Bibliographic source:
Am Ind Hyg Ass J, 23, 95

Materials and methods

Principles of method if other than guideline:
Method similar to Draize protocol. Primary skin irritation on rabbits is recorded in a 10 grade ordinal series, where 10 is the severest reaction. Response is assessed 24 hours after application.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
open
Preparation of test site:
other: clipped
Vehicle:
other: uncertain if unchanged (no vehicle) or water used
Amount / concentration applied:
0.01ml
Duration of treatment / exposure:
24 hours
Observation period:
no data
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: belly

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not specified
Score:
1
Reversibility:
other: not applicable. No effects to reverse
Remarks on result:
other: Exposure non-occluded.
Irritant / corrosive response data:
No irritation observed after 24 hours. Grading scale is 1-10 with 1 equal to no irritation.

Applicant's summary and conclusion

Interpretation of results:
other: unreliable. No occlusion
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Exposure needs to be occluded to make results reliable.
Executive summary:

A skin irritation study exposed rabbits to ethyl acetate and observed no irritation. However, since the study used non-occluded exposure and a very small application volume, the result cannot be considered reliable as a predictor of primary irritation