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Administrative data

Description of key information

Acute oral toxicity:The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value was >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity as 'Not Classified'.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data from secondary source
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Evaluation of acute oral toxicity of test chemical in rats.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route of administration:
other: Oral- by stomach tube
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
4600, 6800, 10200, 15400 and 23100 mg/kg (4.6, 6.8, 10.2, 15.4 and 23.1 g/kg)
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: No data available
- Other examinations performed: No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed at 4600mg/kg bw, while Rats treated with 15400 and 23100 mg/kg all died within 96 hr.
Two rats from each of these groups died after 36 hr.
Clinical signs:
Sedation and anorexic were observed within one hr of treatment with doses of 6800 and 10200 mg/kg.
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: Not classified
Conclusions:
The LD50 value was considered to be > 4600mg/kg bw when rats were treated with test chemical orally.
Executive summary:

In acute oral toxicity study, test chemical was administered by stomach tube to groups of 4 Sprague Dawley rats in doses of 4600, 6800, 10200, 15400 and 23100 mg/kg. The rats were then observed for 14 days. No effects were seen at the lowest dose, sedation and anorexic were observed within one hour of treatment with doses of 6800 and 10200 mg/kg. Two rats from each of these groups died, the remaining appeared normal after 36 hr. Rats treated with15400 and 23100 mg/kg all died within 96 hr. The test chemical was excreted percutaneously and in urine and feces. Hence,LD50 value was considered to be > 4600mg/kg bw when rats were treated with test chemical orally. Therefore according to CLP regulation, the test chemical cannot be classified for Acute oral toxicity.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
4 600 mg/kg bw
Quality of whole database:
Data is Klimicsh 4 and from secondary source

Additional information

Acute oral toxicity

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 for test chemical. The studies are summarized as below –

In acute oral toxicity study, test chemical was administered by stomach tube to groups of 4 Sprague Dawley rats in doses of 4600, 6800, 10200, 15400 and 23100 mg/kg. The rats were then observed for 14 days. No effects were seen at the lowest dose, sedation and anorexic were observed within one hour of treatment with doses of6800 and 10200 mg/kg. Two rats from each of these groups died, the remaining appeared normal after 36 hr. Rats treated with15400 and 23100 mg/kgall died within 96 hr. The test chemical was excreted percutaneously and in urine and feces. Hence,LD50 value was considered to be > 4600mg/kg bw when rats were treated with test chemical orally.Therefore according to CLP regulation, the test chemical cannot be classified for Acute oral toxicity.

Two more experiments were designed and conducted to determine the acute oral toxicity profile of test chemical in Sprague Dawley rats. Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in diarrhoea (reddish colour stools), reduced locomotor activity and ataxic gait in all animals with onset at 30 minutes to 4 hours after the dosing. One animal died on day 1 after the dosing. As one mortality was observed at 24 hours after the dosing, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in diarrhoea (reddish colour stools), reduced locomotor activity and ataxic gait in all animals with onset at 30 minutes to 2 hours after the dosing. One animal died on day 1 after the dosing. All animals from 300 mg/kg dose group survived through the study period of 14 days and two animals died from 2000 mg/kg dose group after the dosing. Staining of the stool is attributed to the red colour of the test item. Gross pathological examination did not reveal any abnormalities in animals terminal sacrificed from 300 mg/kg and 2000 mg/kg dose groups.Gross pathological examination revealed reddish discolouration of digestive tract from stomach to anal area with liquid faecal material in found dead animals from 2000 mg/kg dose group. The acute oral LD50 of test chemical was >2000 mg/kg body weight . Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category not classified” criteria of CLP.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as "Not classified" according to CLP regulation.

 

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity and comes under Category "Not classified".