Hexadecyltrimethylammonium methyl sulphate

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:

Representative molecular formula of the major constituents, as the substance is an UVCB: C12 ADMAES: C18H41N1O4S1 C14 ADMAES: C20H45N1O4S1

IUPAC Name:

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

Test material form:

solid

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 600 mg/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 570 mg a.i./kg bw

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

Any other information on results incl. tables

For details, kindly refer to the attached background material section of the IUCLID.

Applicant's summary and conclusion

Interpretation of results:

other: Acute Tox. 4 based on CLP criteria

Conclusions:

Under the study conditions, the acute 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, C12-14 ADMAES (> 95% active), in Sprague-Dawley rats according to OECD 401 Guideline. Groups of five Sprague-Dawley rats (5/dose) received a single oral (gavage) dose of 600 mg/kg bw of the test substance. Parameters evaluated included survival, clinical observations, body weight and necropsy findings in all animals after a 14 or 21 day observation period in females and males, respectively. Mortality was observed at 500, 750 and 1,000 mg/kg in females and 600 mg/kg in males. 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) (Molinier, 1995).