Registration Dossier
Registration Dossier
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EC number: 238-851-7 | CAS number: 14782-75-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27/11/2003 to 15/1/2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Aluminium ethyl acetoacetate neopentyl glycol complexes
- Cas Number:
- 569319-64-8
- Molecular formula:
- C11H19AlO5
- IUPAC Name:
- Aluminium ethyl acetoacetate neopentyl glycol complexes
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- The substance is the Source of the read-across.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Nulliparous and non-pregnant mice, weight range of 15 to 23 g, and 8 to 12 weeks old. Free access to food and mains tap water.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10 or 25%
- No. of animals per dose:
- 5
- Details on study design:
- Preliminary screening suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest concentration. The mice were treated by daily application of 25 microlitres of the test material to the dorsal surface of each ear for three consecutive days.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.72
- Test group / Remarks:
- 5 animals; 5% w/w in acetone/olive oil, 4:1
- Key result
- Parameter:
- SI
- Value:
- 2.42
- Test group / Remarks:
- 5 animals; 10% w/w in acetone/olive oil, 4:1
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- 5 animals; 25% w/w in acetone/olive oil, 4:1
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considered to be a non-sensitiser.
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