Carbon tetrachloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: New testing design followed (in line with OECD TG 401). No individual data, limited reporting of experimental details

Data source

Reference

Reference Type:

publication

Title:

A new approach to practical acute toxicity testing.

Author:

Lorke D.

Year:

1983

Bibliographic source:

Arch Toxicol., vol. 54, no. 4, p. 275-87.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

- this survey study was conducted to evaluate a new strategy for determination of LD50 values with a lower number of animals
- nevertheless in total 11 animals were used for each dose group

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Carbon tetrachloride

EC Number:

200-262-8

EC Name:

Carbon tetrachloride

Cas Number:

56-23-5

Molecular formula:

CCl4

IUPAC Name:

tetrachloromethane

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

- Acclimation period: 5 d
- no further details reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

- no details reported

Doses:

1500, 2000, 2800, 3900 mg/kg bw

No. of animals per sex per dose:

in total 11

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days or longer until the surviving animals stated gaining weight again
- Frequency of observations and weighing: days 0, 7, 14 and weekly thereafter if necessary
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs daily

Statistics:

Method of Rosiello et al. (RosieUo AP, Essigmana JM, Wogan GN (1977) Rapid and accurate determination of the median lethal dose (LDSo) and its error with a smalI computer. J Toxicol Environm Health 3: 797-809), based on the method by Bliss (1938).

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

2 500 mg/kg bw

Mortality:

1500 mg/kg bw 0/11
2000 mg/kg bw 5/11
2800 mg/kg bw 6/11
3900 mg/kg bw 11/11

Clinical signs:

other: - not reported

Gross pathology:

- not reported

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: According to EU directive 67/548/EEC and EU RegAccording to EU directive 67/548/EEC and EU Regulation (EC) N0. 1272/2008 (CLP)

Conclusions:

The present study (Lorke, 1983) states a LD50 (rat, oral) of 2500 mg/kg bw after single oral application via gavage.

Executive summary:

The potential of the test substance CTC (carbon tetrachloride) to induce toxicity upon exposure via the oral route was evaluated in a survey study on different substances following generally OECD TG 401. The scope of the study was to evaluate a new strategy to determine LD50 values with a lower amount of animals. Nevertheless the total amount of tested animals in each dose group allowed for CTC a classical determination of a LD50 value according to OECD TG 401. Male rats (unspecified strain) were treated at a single oral dose bw with CTC (unknown vehicle). Observation period was 14 d and further experimental details were not reported but stated to be conducted according to OECD TG 401.

The mortality incidences were 0/11 at 1500 mg/kg bw, 5/11 at 2000 mg/kg, 6/11 at 2800 mg/kg and 11/11 at 3900 mg/kg.

The LD 50(rat, oral) was therefore assessed to be 2500 mg/kg bw after single oral application via gavage.