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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

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.

Justification for type of information:

Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

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

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

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

Preliminary study:

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

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

Interpretation of results:

other: CLP criteria not met

Remarks:

(not classified)

Conclusions:

Based on the results of the read across study, the acute oral LD50 of the substance in rats is considered to be 3190 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the read across 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 read across 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). Based on the results of the read across study, similar oral LD50 is expected for the test substance, C18-22 TMAC.