Quaternary ammonium compounds, C18-22 (even numbered) alkyltrimethyl, chlorides; Docosyltrimethylammonium chloride; C18-22 TMAC

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1972 to 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test performed before OECD and GLP guidelines. Important aspects (14 day-postobservation time) in line with current OECD guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute oral toxicity after single application

GLP compliance:

no

Remarks:

Performed before GLP guidelines

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides

EC Number:

271-756-9

EC Name:

Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides

Cas Number:

68607-24-9

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst
- Age at study initiation: no data
- Weight at study initiation: 82-104 g (mean 93 g )
- Fasting period before study: 16 h
- Housing: in plastic cages
- Diet (e.g. ad libitum): Standard Altromin R, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 %
- Amount of vehicle (if gavage): dependent on dose, not constant
- Justification for choice of vehicle: not given

MAXIMUM DOSE VOLUME APPLIED: 50 mL/kg

Doses:

800, 1250, 2000, 3200, and 5000 mg/kg

No. of animals per sex per dose:

10 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing once per week
- Necropsy of survivors performed: unclear from report
- Other examinations performed: body weight, no further information

Statistics:

LD50 was calculated using Probit analysis

Results and discussion

Preliminary study:

No sex differences were observed in preliminary study, therefore only females were used in the main study

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

3 190 mg/kg bw

Remarks on result:

other: not classified

Mortality:

The following number of deaths were observed per dose group:

dose (mg/kg) -- number of death animals -- number of total animals
800 -- 0 -- 10
1250 -- 0 -- 10
2000 -- 1 -- 10
3200 -- 5 -- 10
5000 -- 10 -- 10

Clinical signs:

other: Not reported

Gross pathology:

Uunclear if done

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Remarks:

(not classified)

Conclusions:

Under the study conditions, the acute oral LD50 of the substance in rats was determined to be 3190 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, C20-22 TMAC (active: 96.6%), according to a method similar to OECD Guideline 401 (standard acute method). Group of 10 female wistar rats each were administered test substance at doses of 800, 1250, 2000, 3200 and 5000 mg/kg bw by oral gavage. Following administration, the animals were observed for 14 d and mortality and body weights were recorded daily. Dose dependant mortality was observed at the end of the study. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be 3190 mg/kg bw (Scholz and Weigand, 1973).