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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between 300 to 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 'category 4'.

 

Acute Inhalation Toxicity:

The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the test chemical. The LC50 value is <5 mg/l, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute inhalation toxicity 'category 1'.

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 authoritative database.
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To determine the Acute Oral toxicity of test chemical in rats.
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:
600 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:
600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No data available
Mortality:
50% mortality observed at 600 mg/kg bw dose level.
Clinical signs:
other: not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 value for test chemical was observed to be 600 mg/kg bw when administered to rats via oral route.
Executive summary:

Acute oral toxicity study was performed on rats to determine the toxic nature of test chemical. A LD50 value of 600 mg/kg bw was observed when the test chemical was administered to rats via oral route. Thus indicating that the test chemical can be classified as 'Acute oral Category 4' according to the CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
600 mg/kg bw
Quality of whole database:
Data is from publication and klimish rating 2.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
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 authoritative database.
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To determine the Acute Inhalation toxicity of test chemical in rats.
GLP compliance:
not specified
Test type:
other: not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
not specified
Duration of exposure:
4 h
Remarks on duration:
not specified
Concentrations:
475mg/m3 (0.475 mg/l)
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:
LC50
Effect level:
475 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: No details available
Mortality:
50% mortality observed at a dose level of 475mg/m3.
Clinical signs:
other:
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
Category 1 based on GHS criteria
Conclusions:
The LC50 for the test chemical was determined to be 475mg/m3 (0.475 mg/l) when administered to rats for 4 hours.
Executive summary:

Acute inhalation toxicity study was performed on rats to determine the toxic nature of test chemical. The test chemical was administered to rats via inhalation route for 4 hours. LC50 value of 475mg/m3 (0.475 mg/l) was observed indicating that the test chemical is highly toxic. As the LC50 value is < 0.5 mg/l, the test chemical can be classified as 'Category 1' for inhalation route according to CLP regulation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
0.475 mg/m³ air
Quality of whole database:
Data is from publication and klimish rating 2.

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 –

Acute oral toxicity study was performed on rats to determine the toxic nature of test chemical. A LD50 value of 600 mg/kg bw was observed when the test chemical was administered to rats via oral route. Thus indicating that the test chemical can be classified as 'Acute oral Category 4' according to the CLP regulation.

In another study, The acute oral toxicity study was conducted by using the given test chemical in adult Sprague-Dawley rats at the dose concentration of 479 mg/kg bw. Animals were observed for mortality. 50% mortality was observed at 479±42 mg/kg bw. Hence, the acute oral LD50 was determined to be 479 mg/kg bw, when adult Sprague-Dawley rats were treated with the given test chemical via oral route.

In a similar study, Acute oral toxicity study was performed on rats to determine the toxicity of test chemical. Test chemical was administered to more than 200 white rats via stomach tube .4 gm of test chemical was dissolved in 100 cc distilled water and dose concentrations of 600, 800,1000, 1200 and 1400 mg/kg bw were prepared, the dosage of the solutions were proportional to body weights and are reported in terms of weights of the drug which were dissolved in the volumes administered. Four percent solutions were sufficiently diluted to avoid irritation and vomiting. The test chemical was administered to rats via stomach tube from which food but not water had been withheld 16 hours. The LD50 value was determined to 880 mg/kg bw indicating that the test chemical is toxic in nature. The LD50 value falls between the range 300 to 2000 mg/kg bw, therefore the test chemical can be classified as 'Category 4' for acute oral toxicity.

Thus, based on the above summarized 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 for acute oral toxicity 'Category 4'.

Acute inhalation toxicity:

In different studies, the given test chemical has been investigated for acute inhalation 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 –

Acute inhalation toxicity study was performed on rats to determine the toxic nature of test chemical. The test chemical was administered to rats via inhalation route for 4 hours. LC50 value of 475mg/m3 (0.475 mg/l) was observed indicating that the test chemical is highly toxic. As the LC50 value is < 0.5 mg/l, the test chemical can be classified as 'Category 1' for inhalation route according to CLP regulation.

In a similar study, acute inhalation toxicity study was performed on mice to determine the toxic nature of test chemical. The test chemical was administered to mice via inhalation route. LC50 value of 445mg/m3 (0.445 mg/l) was observed indicating that the test chemical is highly toxic. As the LC50 value value is < 0.5 mg/l, the test chemical can be classified as 'Category 1' for inhalation route according to CLP regulation.

Thus, based on the above summarized studies on test chemical, it can be concluded that LC50 value is <5 mg/l. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute inhalation toxicity 'Category 1'.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity and for acute inhalation toxicity, the LC50 value was <0.5 mg/l. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity 'Category 4' and acute inhalation toxicity 'Category 1'.