Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

- Principle of test: Six male Sprague-Dawley rats were administered either 5 or 10 g/kg bw of a 25 % solution (in distilled water) of the test substance by oral gavage.The animals were observed for two weeks.
- Short description of test conditions: Animals were given a single dose and then placed in screen bottom cages with free access to water and laboratory chow for a two week observation period.
- Parameters analysed / observed: Mortality

GLP compliance:

no

Remarks:

performed before implementation of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates

Cas Number:

68002-58-4

IUPAC Name:

Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-250 g
- Fasting period before study: 24 h
- Housing: screen bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%

MAXIMUM DOSE VOLUME APPLIED: not specified

DOSAGE PREPARATION (if unusual): none

Doses:

5 and 10 g/kg bw

No. of animals per sex per dose:

6 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not examined
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

act. ingr.

Mortality:

One animal died on day 7 in the 10 g/kg bw group

Clinical signs:

other: not reported

Gross pathology:

not examined

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The single administration of 10 mg/kg bw C14-18 alykldimethyl ammonium methosulfate to male Sprague-Dawley rats caused one death among 6 animals in this dosage group on observation day 7. The other animals, i.e. 6 animals in the 5 g/kg bw dosage group and 5 animals in the 10 g/kg bw dosage group survived during the whole experimental time Thus, the LD50 of the test substance was considered to be > 10 g/kg bw.

Executive summary:

In an acute oral toxicity study (performed before implementation of GLP and OECD guidelines), groups of 6 male fasted Sprague-Dawley rats were given a single oral dose of C14 -18 alkyldimethyl ammonium methosulfate (89% a.i.) in water at doses of 5 or 10 g/kg bw and observed for 14 days. One animal died on day 7 in the 10 g/kg bw group; all animals of the 5 g/kg bw group survived to the end of the observation period.

 

Oral LD50 Males >10 g/kg bw