[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 03, 1982 to August 24, 1982

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:

1982

Report date:

1982

Materials and methods

Principles of method if other than guideline:

Groups of 10 female Wistar rats were exposed to the test substance via oral gavage at 0, 250, 400, 630 and 1000 mg/kg bw. Clinical signs, mortality and bodyweight were recorded during 14 d post-dosing. At study end, a gross macroscopic examination was conducted. LD50 values were calculated by PROBIT analysis.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium chloride

Molecular formula:

C15H34Cl1N1 (representative molecular formula of C12 chain)

IUPAC Name:

N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium 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:

Dihydrogen oxide

Test material form:

liquid

Specific details on test material used for the study:

- Präpagen 2916

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst breeding
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Weight at study initiation: 233-253 g
- Fasting period before study: 16 h
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Germany)
- Water (e.g. ad libitum): tap water

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was prepared as a 25% solution in water.

Doses:

0, 250, 400, 630 and 1000 mg/kg bw.

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 calculated by PROBIT analysis (method of Linder and Weber). Confidentiality limits calculated according to Fieller.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

448 mg/kg bw

Based on:

test mat.

95% CL:

ca. 322 - ca. 593

Mortality:

250 mg/kg bw, 25% concentration: mortality = 2/10 animals
400 mg/kg bw, 25% concentration: mortality = 4/10 animals
630 mg/kg bw, 25% concentration: mortality = 6/10 animals
1000 mg/kg bw, 25% concentration: mortality = 10/10 animals

Clinical signs:

other: Clinical signs included hyperactivity, high leg posture, crouching, stomach and flanks tucked in, exophtalmia, noisy and sometimes irregular breathing, as well as rapid breathing. On Day 2, all surviving rats still showed noisy breathing. At 630 mg/kg bw,

Gross pathology:

Macroscopic examination revealed blood in the lungs, which were in part grey-red discolored, dark brown discoloration of the liver and diffuse digestive tract, in part strongly reddened. The gastrointestinal tract was gelatinous with isolated petechial bleedings. Its appearance was transparent and it was mostly filled with a yellow-reddish mass.

Applicant's summary and conclusion

Interpretation of results:

other: Category 4 based on CLP criteria

Conclusions:

Under the study conditions, the acute oral LD50 for the test substance in rats was equivalent to 448 mg/kg bw (CL = 322 - 593 mg/kg bw).

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, C12-14 TMAC (active ingredient 40%), in rats. Groups of 10 female Wistar rats were exposed to the test substance via oral gavage at 0, 250, 400, 630 and 1000 mg/kg bw. The test substance was prepared as a 25% solution in water. As it is not clear if the active ingredient corrections have been applied, the doses are mentioned as such. Clinical signs, mortality and bodyweight were recorded during 14 d post-dosing. At study end, a gross macroscopic examination was conducted. LD50 values were calculated by PROBIT analysis. Clinical signs included hyperactivity, high leg posture, crouching, stomach and flanks tucked in, exophtalmia, noisy and sometimes irregular breathing, as well as rapid breathing. On Day 2, all surviving rats still showed noisy breathing. At 630 mg/kg bw, high leg posture and flanks tucked in were recorded until end of Day 4. No clinical signs were apparent as of Day 5. Bodyweights of surviving animals were within normal ranges throughout the study. Macroscopic examination revealed blood in the lungs, which were in part grey-red discolored, dark brown discoloration of the liver and diffuse digestive tract, in part strongly reddened. The gastrointestinal tract was gelatinous with isolated petechial bleedings. Its appearance was transparent and it was mostly filled with a yellow-reddish mass. Under the study conditions, the acute oral LD50 for the test substance in rats was equivalent to 448 mg/kg bw (CL = 322 - 593 mg/kg bw) (Mayer and Weigand, 1982).