Quaternary ammonium compounds, C12-14-alkyltrimethyl, Me sulfates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, C12-14 (even-numbered)-alkylethyldimethyl, ethyl sulphates

EC Number:

939-607-9

Molecular formula:

C18 H41 N1 O4 S1

IUPAC Name:

Quaternary ammonium compounds, C12-14 (even-numbered)-alkylethyldimethyl, ethyl sulphates

Test material form:

other: solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): N-alkyl "coco" diméthyl éthyl ammonium ethosulfate
- Purity >95%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, 69210 L'arbresle, France
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 178 +/- 7 g for males, 159 +/- 8 g for females
- Fasting period before study: 1 day
- Housing: housed in groups by sex
- Diet (e.g. ad libitum): "Rats et Souris entretien référence A04C" (U.A.R., 9160 Villemoisson-sur-Orge, Fance)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12/h
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Males:
- 600 mg/kg (10 mL/kg)

Females:
- 200 mg/kg (10 ml/kg)
- 500 mg/kg (10 ml/kg)
- 750 mg/kg (15 ml/kg)
- 1,000 mg/kg (20 ml/kg)

No. of animals per sex per dose:

5 animals

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 d for females and 21 d for males
- Frequency of observations and weighing: Animals observed for clinical signs and mortality at frequent intervals on Day 1 and twice daily thereafter; body weight measured on Day 1, 8, 15 and 22.
- Necropsy of survivors performed: yes, animals were sacrificed by CO2.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

600 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

570 mg/kg bw

Based on:

act. ingr.

Mortality:

Females: No mortality observed at 200 mg/kg. 20, 80 and 100% mortality observed at 500, 750 and 1,000 mg/kg bw, respectively.
Males: 20% mortality observed at 600 mg/kg bw.

Clinical signs:

other: Females: - 200 and 500 mg/kg: hypoactivity on 4/5 animals on the day of administration. - 750 mg/kg: sedation, hypoactivity, lateral decubitus, dyspnoea, piloerection - 1,000 mg/kg: sedation, hypoactivity, piloerection, contaminated uro-vaginal area Mal

Applicant's summary and conclusion

Interpretation of results:

other: Acute Tox. 4 based on CLP criteria

Conclusions:

Under the study conditions, the acute oral median lethal dose (LD50) of the test substance in male/female rats was found to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw).

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance in Sprague-Dawley rats according to OECD Guideline 401. Male Sprague-Dawley rats received a single oral (gavage) dose of 0 and 600 mg/kg bw and females received oral (gavage) doses of 0, 200, 500, 750 and 1000 mg/kg bw of the test substance. Parameters evaluated included survival, clinical observations, body weight and necropsy findings in all animals after 14 or 21 days observation period in females and males, respectively. Mortality was observed at 500, 750 and 1,000 mg/kg bw in females and 600 mg/kg bw in males. Under the study conditions, the acute oral LD50 of the test substance in male/female rats was found to be >600 mg/kg bw (equivalent to 570 mg a.i./kg bw) (Molinier, 1995).