Registration Dossier
Registration Dossier
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EC number: 203-721-0 | CAS number: 109-94-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Formic acid ethyl ester
- Author:
- Wiley Online Library
- Year:
- 2 003
- Bibliographic source:
- The MAK Collection for Occupational Health and Safety
- Reference Type:
- other:
- Title:
- Acute dermal toxicity of Ethyl Formate
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- ChemIDplus
- Reference Type:
- other: secondary source
- Title:
- Formic acid, ethyl ester
- Author:
- RTECS
- Year:
- 2 013
- Bibliographic source:
- RTECS
- Reference Type:
- secondary source
- Title:
- 473. Ethyl formate
- Author:
- WHO
- Year:
- 1 979
- Bibliographic source:
- WHO
- Reference Type:
- other: secondary source
- Title:
- Ethyl formate - Health-based reassessment of administrative occupational exposure limits
- Author:
- Health Council of the Netherlands
- Year:
- 2 002
- Bibliographic source:
- Health Council of the Netherlands
- Reference Type:
- other: secondary source
- Title:
- Scientific Literature Reviews
- Author:
- U.S. Food and Drug Administration
- Year:
- 1 974
- Bibliographic source:
- U.S. Food and Drug Administration
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute dermal toxicity of the given test chemical in rabbit.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl formate
- EC Number:
- 203-721-0
- EC Name:
- Ethyl formate
- Cas Number:
- 109-94-4
- Molecular formula:
- C3H6O2
- IUPAC Name:
- ethyl formate
- Details on test material:
- - IUPAC Name: Ethyl formate
- InChI: 1S/C3H6O2/c1-2-5-3-4/h3H,2H2,1H3
- Smiles: O(CC)C=O
- Molecular formula :C3H6O2
- Molecular weight:74.0784 g/mol
- Substance type:Organic
- Physical state:liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand giant albino rabbits
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 – 3.5 gm
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin
- % coverage: 1/10 of the body surface
- Type of wrap if used: an impervious plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the film was removed
- Time after start of exposure:24 hours - Duration of exposure:
- 24 hours
- Doses:
- 20000 mg/kg bw
- No. of animals per sex per dose:
- 4 rabbits/dose
- Control animals:
- not specified
- Details on study design:
- - Other examinations performed: Animals were observed for a period of 14 days for signs of systemic toxic effects.
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- All rabbits survived the maximum dosage that could be retained in contact with the skin by the method employed.
- Clinical signs:
- other: No adverse effects were reported.
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute dermal LD50 value was considered to be >20000 mg/kg bw, when group of 4 male New Zealand giant albino rabbits were treated with the given test chemical by dermal application occlusively.
- Executive summary:
Acute dermal toxicity study of the given test chemical was conducted in group of 4 male New Zealand giant albino rabbits at the dose concentration of 20000 mg/kg bw.
Test chemical applied to the skin (hair removed by clipping) over about 1/10 of the body surface and retained in contact with the skin by means of an impervious plastic film. After an exposure period of 24 hours, the film was removed.
Animals were observed fora period of 14 days for signs of systemic toxic effects. All rabbits survived the maximum dosage that could be retained in contact with the skin by the method employed. No adverse effects were reported.
Therefore, LD50 value was considered to be >20000 mg/kg bw, when group of 4 male New Zealand giant albino rabbits were treated with test chemical by dermal application occlusively.
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