Registration Dossier
Registration Dossier
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EC number: 229-778-1 | CAS number: 6728-26-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2008
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Dermal Sensitization quantitative risk assessment (QRA) for fragrance ingredients
- Author:
- A.M. Api et al
- Year:
- 2 007
- Bibliographic source:
- Regulatory Toxicology and Pharmacology 52
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Local Lymph Node Assay; details on guidelines not specified.
- Deviations:
- not specified
- Principles of method if other than guideline:
- Local Lymph Node Assay; no further details on the method were reported.
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- trans-hex-2-enal
- EC Number:
- 229-778-1
- EC Name:
- trans-hex-2-enal
- Cas Number:
- 6728-26-3
- Molecular formula:
- C6H10O
- IUPAC Name:
- trans-hex-2-enal
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- No details reported.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No details reported.
Study design: in vivo (LLNA)
- Vehicle:
- not specified
- Concentration:
- No details reported.
- No. of animals per dose:
- No details reported.
- Details on study design:
- No details reported.
- Positive control substance(s):
- not specified
- Statistics:
- No details reported.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- 4.048
- Remarks on result:
- other: LLNA weighted mean EC3 value ( 1012 μg/cm2); converted to 4.048 % concentration based on the assumption that the application of 25 μl of a 1 % solution results in a dose per unit area of 250 μg/cm2.
- Remarks:
- Considered 'moderate'
- Parameter:
- SI
- Variability:
- No details reported
- Test group / Remarks:
- No details reported
- Remarks on result:
- other: No details reported
- Cellular proliferation data / Observations:
- No details reported.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The LLNA EC3 value was reported as a weighted mean of two studies with a value of 1012 μg/cm2. The authors reported this value to be a 'moderate' skin sensitiser. Assuming that the application of 25 μl of a 1 % solution results in a dose per unit area of 250 μg/cm2 the EC3 value is converted to a percentage concentration of 4.048. Therefore, the test item is classified as a Category 1A for skin sensitisation (H317) according to CLP criteria (EC Regulation 1272/2008).
- Executive summary:
The LLNA EC3 value was reported as a weighted mean of two studies with a value of 1012 μg/cm2. The authors reported this value to be a 'moderate' skin sensitiser. Assuming that the application of 25 μl of a 1 % solution results in a dose per unit area of 250 μg/cm2 the EC3 value is converted to a percentage concentration of 4.048. Therefore, the test item is classified as a Category 1A for skin sensitisation (H317) according to CLP criteria (EC Regulation 1272/2008).
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