Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Constituent 1
Chemical structure
Reference substance name:
Ethyl acetate
EC Number:
205-500-4
EC Name:
Ethyl acetate
Cas Number:
141-78-6
Molecular formula:
C4H8O2
IUPAC Name:
ethyl acetate
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