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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019.03.12~2019.05.21
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17th DEC 2001
GLP compliance:
yes
Test type:
acute toxic class method

Test material

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

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Remarks:
RAT, SPF
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sterile distilled water
Details on oral exposure:
This vehicle has been used widely in toxicity study.
Before the study initiation date, this vehicle was chosen
as appropriate vehicle of test substance preparation through
the vehicle test.
Doses:
300mg/kg ~ 2,000mg/kg B.W
No. of animals per sex per dose:
3
Control animals:
not specified

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The test substance-related dead animals were observed in the dose of 2000 mg/kg
body weight (3rd step) at 3 animals (2301 – 2303 : 1 day).
Clinical signs:
In clinical signs, soiled perineal region [(2103 : 1 day) / (2201, 2203 : 1 day)] were
observed in the dose of 300 mg/kg body weight (1st , 2nd step).
Body weight:
In body weight for animal except dead animals, the other animals showed the normal
increase of body weight during the study period.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on these results, Trimethyloctylammonium methyl sulphate was classified into
GHS (Globally Harmonized Classification System for Chemical Substances and
Mixtures) Category 4 (300 mg/kg body weight < LD50 < 2000 mg/kg body weight) in
this study.