Registration Dossier

Administrative data

Description of key information

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 1297 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as category 4 for acute oral toxicity.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from publication
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of test chemical on rats
GLP compliance:
not specified
Test type:
standard acute method
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
Not specified
Doses:
937mg/kg bw - 2135 mg/kg bw
No. of animals per sex per dose:
Not specified
Control animals:
not specified
Details on study design:
Not specified
Statistics:
Not specified
Preliminary study:
Not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 297 mg/kg bw
Based on:
test mat.
95% CL:
>= 937 - <= 2 135
Remarks on result:
other: 50% mortality observed
Mortality:
50% mortality observed
Clinical signs:
Not specified
Body weight:
Not specified
Gross pathology:
Not specified
Other findings:
Not specified
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Acute oral toxicity value of test chemical to rats was determined to be LD50:1297 mg/kg with 95% confidence limits (937-2135).
Executive summary:

In acute oral toxicity study, rats were treated with test chemical at a concentration of 937 - 2135 mg/kg bw orally. 50% mortality was observed at 1297 mg/kg bw in treated rat. Therefore, LD50 was considered to be 1297 mg/kg bw with 95% confidence limits (937 -2135) when rats were treated with test chemical orally and the test chemical can be classified as acute oral toxic category 4 as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 297 mg/kg bw
Quality of whole database:
Data is Klimish 2 and from publication

Additional information

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and mouse for test chemical. The studies are summarized as below –

1) In acute oral toxicity study, rats were treated with test chemical at a concentration of 937 - 2135 mg/kg bw orally. 50% mortality was observed at 1297 mg/kg bw in treated rat. Therefore, LD50 was considered to be 1297 mg/kg bw with 95% confidence limits (937 -2135) when rats were treated with test chemical orally and the test chemical can be classified as acute oral toxic category 4 as per CLP regulation.

2) In acute oral toxicity study, rats were treated with test chemical at a concentration of 1300 mg/kg bw orally. 50% mortality was observed at 1300 mg/kg bw in treated rat. Therefore, LD50 was considered to be 1300 mg/kg bw when rats were treated with test chemical orally and the test chemical can be classified as acute oral toxic category 4 as per CLP regulation.

3)In acute oral toxicity study, mice were treated with test chemical at a concentration of 474 - 1493 mg/kg bw orally. 50% mortality was observed at 841 mg/kg bw in treated animals. Therefore, LD50 was considered to be 841 mg/kg bw when mice were treated with test chemical orally and the test chemical can be classified as acute oral toxic category 4 as per CLP regulation.

4)In acute oral toxicity study, mice were treated with test chemical at a concentration of 840 mg/kg bw orally. 50% mortality was observed at 840 mg/kg bw in treated animals. Therefore, LD50 was considered to be 840 mg/kg bw when mice were treated with test chemical orally and the test chemical can be classified as acute oral toxic category 4 as per CLP regulation.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is between 300 - 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as category 4 for acute oral toxicity.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is 1297 mg/kg bw, for acute oral. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as category 4 for acute oral.