Registration Dossier
Registration Dossier
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EC number: 922-223-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- Oligomerisation products of 2-(chloromethyl)oxirane and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol
- EC Number:
- 922-223-0
- Molecular formula:
- not applicable for UVCB
- IUPAC Name:
- Oligomerisation products of 2-(chloromethyl)oxirane and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- rabbit
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Positive control substance(s):
- eugenol (CAS No 97-53-0)
Results and discussion
- Positive control results:
- The mean SI value of Eugenol 25 %(w/v) as positive control was determined as 4.656.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 4.478
- Test group / Remarks:
- 25.0 %(w/v) group
- Key result
- Parameter:
- SI
- Value:
- 4.112
- Test group / Remarks:
- 10.0 %(w/v) group
- Key result
- Parameter:
- SI
- Value:
- 3.344
- Test group / Remarks:
- 5.0 %(w/v) group
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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