Registration Dossier
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EC number: 700-323-3 | CAS number: 908020-52-0
Skin sensitisation
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Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration (% w/v) Stimulation index Result 0 1.0 - 10 1.1 negative 25 2.2 negative 50 1.9 negative
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration (% w/v) Disintegrations per minute 0 4137.1 10 4562.3 25 9113.3 50 7877.1
Any other information on results incl. tables
3H-thymidine incorporation in the auricular lymph nodes in animals treated with a 10% concentration EEA-NH4 was similar to that in vehicle control animals, whereas3H‑thymidine incorporation was statistically significantly enhanced at 25% and 50% concentrations. Stimulation indices (SI’s) of 1.1, 2.2 and 1.9 were calculated in response to a 10%, 25% and 50% EEA-NH4 concentration respectively. Since the SI’s were lower than 3 at all concentrations the results indicated that EEA-NH4 should not be considered a skin sensitiser (a SI of 3 is the limiting value required for classification as a skin sensitiser).
Applicant's summary and conclusion
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