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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
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
Chemical structure
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 levelsopen allclose all
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
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
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:
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.
Body weight:
Reduced bodyweight compared to the other groups was seen in individual animals at most dosage groups, in particular after 7 days.
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).