Registration Dossier
Registration Dossier
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EC number: 265-332-2 | CAS number: 65059-42-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- LLNA
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019.03.21~2019.05.20
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Version / remarks:
- TG 442B “Local Lymph node assay: BRDU-ELISA or-FCM”
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- Trimethyloctylammonium methyl sulphate
- EC Number:
- 265-332-2
- EC Name:
- Trimethyloctylammonium methyl sulphate
- Cas Number:
- 65059-42-9
- Molecular formula:
- C11H26N.CH3O4S
- IUPAC Name:
- trimethyl(octyl)azanium methyl sulfate
- Test material form:
- solid: bulk
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- > 1.4 - < 2.1
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- To determine the sensitizing potential of topically applied Trimethyloctylammonium
methyl sulphate, the present study(LLNA-BrdU-ELISA) was conducted. The animals
were observed for 6 days after administration and mortality, clinical signs, body
weights, skin reactions, changes in ear thickness, skin Stimulation Index (SI) were
recorded.
No mortality according to the test substance was observed. Animals of all treatment
groups showed a normal change in body weight.
As a result of observing the localized region treated with the test substance, skin
irritation was not observed and significant change was not observed in ear thickness
measurement compared before treatment of the test substance.
The stimulation index (SI) was calculated as 1.4, 1.5, and 2.1 for the test substance
G3 (5 %), G4 (10 %) and G5 (25 %). The stimulation index (SI) of positive control
group (G6) was 2.9.
Based on the results of this study, Trimethyloctylammonium methyl sulphate was
considered as skin sensitization substance (Local Lymph node assay: BrdU-ELISA).
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