Registration Dossier
Registration Dossier
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EC number: 952-218-9 | 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)
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 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:
- Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-)
- EC Number:
- 289-068-2
- EC Name:
- Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-)
- Cas Number:
- 85959-73-5
- Molecular formula:
- C32H22CoN8O16S2.3Na
- IUPAC Name:
- Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-)
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:JN
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 5, 10 and 25 % w/w in the main test
- No. of animals per dose:
- 6 (2 for each dose)
- Positive control substance(s):
- other: Acetone / olive oil 4:1 v/v
Results and discussion
- Positive control results:
- The positive control item was 25% (w/w) alpha-hexylcinnamaldehyde in acetone:olive oil 4:1 v/v.
The assay is considered satisfactory if the Stimulation Index (SI) of the positive control group
is higher than 2.0.
A Stimulation Index of 2.61 was calculated, the study was regarded as valid.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 5.85
- Test group / Remarks:
- 5 % w/w
- Key result
- Parameter:
- SI
- Value:
- 5.86
- Test group / Remarks:
- 10 % w/w
- Key result
- Parameter:
- SI
- Value:
- 6.34
- Test group / Remarks:
- 25 % w/w
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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