Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute toxicity: Oral

Acute oral toxicity study of the test chemical was conducted in rats at the dose concentration of 50 mg/kg bw. 50% mortality was observed. Hence, LD50 value was considered to be 50 mg/kg bw, when rats were treated with the test chemical via oral route.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from handbook.
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity of the test chemical in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
50 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:
50 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed
Mortality:
50% mortality was observed at 50 mg/kgbw
Clinical signs:
other: not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The acute oral LD50 value was considered to be 50 mg/kg bw, when rats were treated with the test chemical via oral route.
Executive summary:

Acute oral toxicity study of the test chemical was conducted in rats at the dose concentration of 50 mg/kg bw. 50% mortality was observed. Hence, LD50 value was considered to be 50 mg/kg bw, whenrats were treated with the test chemical via oral route.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
50 mg/kg bw
Quality of whole database:
Klimisch rating 2

Additional information

Acute toxicity: Oral

Various studies have been reviewed to determine the acute oral toxicity in living organisms. Mostly the studies have been performed on rodents i.e rats, mice. The results are mentioned below:

Acute oral toxicity study of the test chemical was conducted in rats at the dose concentration of 50 mg/kg bw. 50% mortality was observed. Hence, LD50 value was considered to be 50 mg/kg bw, when rats were treated with the test chemical via oral route.

This is supported by another acute oral toxicity study conducted in rats for the test chemical. The test chemical at the dose concentration of 55 mg/kg bw was orally dosed to rats and observed for signs of toxicity. 50% mortality was observed. Hence, LD50 value was considered to be 55 mg/kg bw, when rats were treated with the test chemical via oral route.

These results are lent support by an acute oral toxicity study conducted in male Sprague-Dawley rats to determine the most non-toxic dose of the test chemical. The rats were orally exposed to concentration of 75 (44-127) mg/kg bw of the test chemical. Single oral dose toxicity was usually determined by the method of Smyth et al. (1962) in which the LD50 and its 95% confidence limits are estimated by the moving average technique (Thompson, 1947; Weil, 1952). 50% mortality was observed. Hence,LD50 value was considered to be 75 mg/kg bw, with 95% confidence limits of 44-127 mg/kg bw, when male Sprague-Dawley rats were treated with the test chemical via oral route.

These results are further supported by an acute oral toxicity study conducted on 80 female Sherman strain rats to determine the toxicity of the test chemical. A total of 80 rats were used for the study and the animals were individually caged during the study and fed Purina Laboratory Chow. None of them was fasted prior to dosage. The rats were individually caged in free-standing cages of stainless steel wire mesh measuring 15 inches long, 9 inches wide, and 9 inches high. The test chemical were usually formulated so that the different dosage levels of poison could be given by stomach tube by giving the formulation at a constant rate of 0.005 ml/g of body weight. The test chemical was given as a suspension in 95% ethyl alcohol orally by means of a stomach tube. The survivors were held for daily observation until they appeared to have recovered completely or for a minimum of 14 days. The poisoned rats were observed at least once each hour during the first day after dosage, and twice a day thereafter, for symptoms of poisoning and time of death. The LD50 values were determined by the method of Litchfield and Wilcoson (1949). The minimum survival time of the dosed rats was 1 day and maximum survival time was 4 days. The lowest dose to kill a female rat was 70 mg/kg. The acute oral LD50 value was considered to be 83 mg/kg bw, with 95% confidence limit of 75-91 mg/kg bw, when female Sherman strain rats were treated with the test chemical via oral gavage route.

To substantiate the claims of the above results another acute oral toxicity study was conducted in rats to determine the most non-toxic dose of the test chemical. The test chemical at the dose concentration of 90 mg/kg bw was orally dosed to rats and observed for signs of toxicity. 50% mortality was observed. Hence, LD50 value was considered to be 90 mg/kg bw, when rats were treated with the test chemical via oral route.

The results from the preceding studies are also supported by an acute oral toxicity study conducted in mice to determine the toxicity of the test chemical. The test chemical at the dose concentration of 16 (12-21) mg/kg bw was orally dosed to mice and observed for signs of mortality. 50% mortality was observed. Hence, LD50 value was considered to be16 mg/kg bw, with 95% confidence limit of 12-21 mg/kg bw, when mice were treated with the test chemical via oral route.

All of the above results are ably supported by an acute oral toxicity study performed on mice to observe the toxicity of the test chemical. 8.55 mg/kg of the test chemical was orally dosed to mice and observed for signs of mortality and clinical signs.50% mortality was observed. Clinical signs such as dyspnea, behavioral changes, muscle contraction or spasticity, tremor were observed in treated mice. Hence, LD50 value was considered to be 8.55 mg/kg bw, when mice were treated with the test chemical via oral route.

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be toxic when exposed to living organisms via oral route of exposure. The acute oral LD50 value for the test chemical lies between 50 -200 mg/kg. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category "Category 3 for oral route”.

Justification for classification or non-classification

Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be toxic when exposed to living organisms via oral route of exposure. The acute oral LD50 value for the test chemical lies between 50 -200 mg/kg. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category "Category 3" for oral route.