Registration Dossier
Registration Dossier
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EC number: 812-958-4 | CAS number: 1078712-76-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 26, 2016 to December 14, 20116
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 1078712-76-1
- Molecular formula:
- C23-27H49-59N (Substance is a UVCB)
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 25%, 50%, 100%
- No. of animals per dose:
- 5
Results and discussion
- Positive control results:
- 0.15% DNCB SI = 44.1
25% HCA SI = 22.0
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Value:
- 3.1
Any other information on results incl. tables
Topical application of test article Amines (2-ethylhexyl)(hydrogenated tallow alkyl) methyl,
CAS No. 1078712-76-1, Lot/Batch No. TS 16013, at 25% and 50% (v/v) in propylene glycol, and at 100%
(neat), resulted in SI values greater than 3 (SI > 3), with minimal irritation. Therefore, this test article is a
dermal sensitizer in the Local Lymph Node Assay. Immunophenotyping results of all endpoints at all test
article concentrations exceeded 1.25-fold increases, indicating a positive sensitization response.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Topical application of test article Amines (2-ethylhexyl)(hydrogenated tallow alkyl) methyl,
CAS No. 1078712-76-1, Lot/Batch No. TS 16013, at 25% and 50% (v/v) in propylene glycol, and at 100%
(neat), resulted in SI values greater than 3 (SI > 3), with minimal irritation. Therefore, this test article is a
dermal sensitizer in the Local Lymph Node Assay. Immunophenotyping results of all endpoints at all test
article concentrations exceeded 1.25-fold increases, indicating a positive sensitization response.
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