Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Remarks:

Institute of Experimental Pharmacology and Toxicology, Bratislava, Slovak Repbulic

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide

EC Number:

236-124-9

EC Name:

Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide

Cas Number:

13177-41-8

Molecular formula:

C23H49NO3S

IUPAC Name:

dimethyl(octadecyl)(3-sulfopropyl)azanium hydroxide

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 + 3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical Observation: animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2 and 4 hours later. Each animal was inspected daily for the next 14 days.
Body Weight: individual weights of animals were determined shortly before the test item administration and weekly thereafter.
- Necropsy of survivors performed: yes
- Clinical signs including body weight : changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behavioural patterns. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma
- Other examinations performed: clinical signs, body weight

Statistics:

No, Limit test

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 < mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test substance is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Executive summary:

The test substance administered to 6 females Wistar rats at a limit dose of 2000 mg/kg did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. During necropsy no macroscopic findings were observed in all animals at this dose level.The body weights of all animals increased in normal range during the study.