Registration Dossier

Diss Factsheets

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:
2019
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

Constituent 1
Chemical structure
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

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).