Registration Dossier
Registration Dossier
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EC number: 205-500-4 | CAS number: 141-78-6
Skin irritation / corrosion
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:
- 1 962
- 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 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
Constituent 1
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
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