Registration Dossier
Registration Dossier
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EC number: 948-046-9 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 December 2017 to ****
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl) nonyl-, branched and benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl)-, branched
- Molecular formula:
- Not applicable
- IUPAC Name:
- Reaction mass of benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl) nonyl-, branched and benzenamine, 2-ethyl-N-(2-ethyl-nonylphenyl)-, branched
- Test material form:
- liquid
- Details on test material:
- CAS number: Not yet known
EC Number: Not yet known
Constituent 1
- Specific details on test material used for the study:
- Purity: >93%
Physical State/Appearance: Dark amber viscous liquid
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, 100 (%v/v) in acetone/olive oil 4:1
- No. of animals per dose:
- Five
- 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:
- 2.39
- Test group / Remarks:
- 25 (%v/v) in acetone/olive oil 4:1
- Key result
- Parameter:
- SI
- Value:
- 1.58
- Test group / Remarks:
- 50 (%v/v) in acetone/olive oil 4:1
- Key result
- Parameter:
- SI
- Value:
- 1.14
- Test group / Remarks:
- 100 (%v/v) in acetone/olive oil 4:1
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is classified as a non-sensitizer, according to GHS.
- Executive summary:
The skin sensitization potential of the test material was assessed in female CBA/Ca mice following topical application to the dorsal surface of the ear. The undiluted test item was selected as the highest dose investigated in the main test of the Local Lymph Node Assay following a preliminary screening test using one mouse.
Three groups, each of five mice, were treated with 50 µL (25 µL per ear) of the undiluted test material or the test material as a solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v. A further group of five female animals was treated with acetone/olive oil 4:1 alone in the same manner. The Stimulation Indices (SI) were as follows: 2.39, 1.58, and 1.14 for test material concentrations of 25%, 50%, and 100%, respectively.
The test material was considered to be a non-sensitizer under the conditions of the test and is not classified according to GHS.
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