Cetrimonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 27, 1984 to August 02, 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cetrimonium chloride

EC Number:

203-928-6

EC Name:

Cetrimonium chloride

Cas Number:

112-02-7

Molecular formula:

C19H42N.Cl

IUPAC Name:

hexadecyltrimethylazanium chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Weight at study initiation: 176-201 g for males; 181-219 g for females
- Fasting period before study: 16 h
- Housing: up to 5 animals per cage in Macrolon cages
- Diet : Altromin 1324 (Altromin GmbH, Lage/Lippe) ad libitum
- Water : Tap water ad libitum
- Acclimation period: min 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45 - 65

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

630, 1000, 1600, 2500, 3150 and 4000 mg/kg bw

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of weighing: Days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs, body weight and gross pathological examination

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 410 mg/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 699 mg a.i./kg bw

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 970 mg/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 861 mg a.i./kg bw

Effect levels 3

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 1 550 mg/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 450 mg a.i./kg bw

Mortality:

Mortalities occured from Day 1 to Day 13 of the study.

Clinical signs:

other: Clinical signs observed in the first days in male and female rats included: quiet behaviour, hunched posture, closed eyelids, retracted flanks, rough fur, paleness, noisy unregular breathing, myosis and slimy feces.

Gross pathology:

Animals dying during the study showed the following symptoms:
- Bleeding in the mucous membrane of the stomach, swollen stomach, stomach filled with liquid, slime or feed, glassy appearence of the small intestine, reddened small intestine mucous membrane, small intestine filled with yellowish-clear mass
- Darkened adrenal glands, very full bladder
- Bleeding in the lungs

Animals sacrificed at the end of the study did not present any significant macroscopic changes.

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:

other: Category 4 based on CLP criteria

Conclusions:

Under the study conditions, the acute oral LD50 was determined to be 2,410 mg/kg bw for males/females combined, 2,970 mg/kg bw for males and 1,550 mg/kg bw for females (equivalent to 699, 861 and 450 mg a.i./kg bw, respectively).

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, C16 TMAC (29% active in water) in Wistar rats according to OECD Guideline 401 and EU Method B.1, in compliance with GLP. A group of 10 fasted animals (five males and five females) were administered a single oral dose of the test substance at nominal doses of 630, 1,000, 1,600, 2,500, 3,150 and 4,000 mg/kg bw. The animals were observed for 14 days following exposure. The animals were then sacrificed and subjected to gross pathological examination. The animals responded with squatting position and retracted flanks; the breathing was affected. At autopsy the animals were observed to have hamorrhagia and irritation of the stomach and intestinal mucosa. Under the study conditions, the acute oral LD50 was determined to be 2,410 mg/kg bw for males/females combined, 2,970 mg/kg bw for males and 1,550 mg/kg bw for females (equivalent to 699, 861 and 450 mg a.i./kg bw, respectively) (Rüpprich and Weigand, 1984).