Registration Dossier
Registration Dossier
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EC number: 203-721-0 | CAS number: 109-94-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- 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 peer reviewed journals
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Fragrance raw materials monographs
- Author:
- Edited by D.L.J Opdyke
- Year:
- 1 978
- Bibliographic source:
- Food and Cosmetics Toxicology, 1978
- Reference Type:
- secondary source
- Title:
- IUCLID dataset for 109-94-4
- Author:
- EUROPEAN COMMISSION – European Chemicals Bureau
- Year:
- 2 000
- Bibliographic source:
- IUCLID dataset, 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Human maximization test
- Principles of method if other than guideline:
- Human maximization test was carried out to determine the allergenic potential of the test chemical
- GLP compliance:
- no
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- not specified
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
- Test material form:
- liquid
- Details on test material:
- - Name of test material : Ethyl formate
- Molecular formula: C3H6O2
- Molecular weight: 74.0784 g/mol
- Smiles: O(CC)C=O
- InChI : 1S/C3H6O2/c1-2-5-3-4/h3H,2H2,1H3
- Substance type: Organic
- Physical state: Liquid
Constituent 1
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% in petrolatum
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% in petrolatum
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 23 human volunteers
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 23
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 23 human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin. - Executive summary:
A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 4% in petrolatum was applied to the skin of 23 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).
The test chemical 4% in petrolatum did not induce any sensitization reactions on the skin of 23 human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin.
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