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Description of key information

There is one study with sufficient reliability with oral administration in rats. Acute toxicity oral in rat was reported as LD50 600 mg/kg bw.

According to this result a classification for acute toxicity oral in Category 4 based on GHS criteria is recommended.

Further one study with oral administration, two studies with intraperitoneal administration, two studies with intravenous administration and four subcutaneous administration have no sufficient reliability and are therefore ignored.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
This method has a similar structure to the acute toxic class method (OECD 423), which was adopted years later in 1996.
Principles of method if other than guideline:
The development of a method for the investigation of the acute toxicity of an unknown chemical substance, with an estimation on the LD50, is described. This method has a similar structure to the acute toxic class method (OECD 423), which was adopted years later in 1996.
GLP compliance:
not specified
Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
Animals were treated with substances after at least 5 days of adaptation.
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
In the initial investigations the range of doses producing the toxic effects is established. Based on these results, further specific doses are administered to calculate an LD50.
Doses:
first part of investigation: 10/100/1000 mg/kg bw, second part of investigation: 100/140/225/370/600/1000 mg/kg bw.
No. of animals per sex per dose:
first part of investigation: 3 animals per dose; second part of investigation: each of the proposed doses was given to groups consisting of one animal, two animals, three animals and five animals.
Control animals:
not specified
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: dose group consisting of 5 animals
Sex:
male
Dose descriptor:
LD50
Effect level:
650 mg/kg bw
Based on:
test mat.
Remarks on result:
other: dose group consisting of 3 animals
Sex:
male
Dose descriptor:
LD50
Effect level:
600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: dose group consisting of 2 animals
Sex:
male
Dose descriptor:
LD50
Effect level:
770 mg/kg bw
Based on:
test mat.
Remarks on result:
other: dose group consisting of 1 animal
Conclusions:
Classification category 4 based on GHS criteria.
Executive summary:
A method for the investigation of the acute toxicity of chemical substances, with an estimation on the LD50, is described.

This approach is a stepwise procedure with the use of 3 male rats in the first step and 1/2/3/5 male rats in the second step. Mortality and/or the moribund status of the animals was observed. This method has a similar structure to the acute toxic class method (OECD 423), which was adopted years later in 1996. The acute toxicity oral in rats was reported as LD50 600 mg/kg bw in male rats.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
600 mg/kg bw
Quality of whole database:
Study period before the adoption of guideline OECD 423, but similar stucture of method.

Additional information

Justification for classification or non-classification