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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
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:
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals 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:
- not reported
Body weight:
- 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.