Registration Dossier
Registration Dossier
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EC number: 615-738-4 | CAS number: 72245-35-3
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:
- 2 021
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:
- Hydrolysis product of chloro(dimethyl)octadecylsilane and silica gel
- EC Number:
- 615-738-4
- Cas Number:
- 72245-35-3
- Molecular formula:
- SiC20H43
- IUPAC Name:
- Hydrolysis product of chloro(dimethyl)octadecylsilane and silica gel
1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 50; 25 and 12.5%
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- SI: 6.4
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Variability:
- 90%
- Test group / Remarks:
- concentration 12.5%
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Variability:
- 89%
- Test group / Remarks:
- concentration 25%
- Key result
- Parameter:
- SI
- Value:
- 1
- Variability:
- 89%
- Test group / Remarks:
- concentrations 50%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since none of the tested concentrations of the test item gave a stimulation index (SI value) higher than 3 in any group receiving the Test Item up to 50%, it was concluded that, under these experimental conditions, this Test Item did not induce contact sensitization to mice in the Local Lymph Node Assay and the EC3 value could not be calculated.
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