Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972-1973

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:

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

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

Molecular formula:

The substance is a quarternary ammonium chloride derived from fatty alcohol. The general chemical structure is R-N(Me)3+ Cl-, whereas the alkylrest R is variable for the main components C20 and C22 but also shorter and longer C-Chains (in smaller amounts)

IUPAC Name:

N,N,N-trimethyl-C20-22-(even numbered)-alkyl-1-aminium chloride

Test material form:

solid

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 mg/kg
1250 mg/kg
2000 mg/kg
3200 mg/kg
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

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:

unclear if done

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of 3190 mg/kg was obtained for the registration substance.

Executive summary:

The registration substance was given to female rats (n = 10 per dose) via gavage at doses of 800, 1250, 2000, 3200 and 5000 mg/kg. No death occured at 800 and 1250 mg/kg. One, five and ten rats died at 2000, 3200 and 5000 mg/kg respectively. The LD50 of 3190 mg/kg was obtained.