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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 is between 300-2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as “Category IV” for acute oral toxicity.

Acute Inhalation Toxicity:

Test chemicalhas very low vapour pressure (16.4 Pa= 0.1230101 mmhg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.

 

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal 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:
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 form peer- reviewed journal
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute Oral toxicity test was carried out to study the effects of test chemical on rats.
GLP compliance:
not specified
Test type:
other: no data
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
1250 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:
1 250 mg/kg bw
Based on:
test mat.
95% CL:
>= 8 200 - <= 189 000
Remarks on result:
other: 50 % mortality observed
Mortality:
50% mortality was observed in treated rat at dose 1250 mg/kg bw.
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
Toxicity Category IV
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be 1250 mg/kg bw (95% CI: 8200-189000),when rats were treated with test chemical orally.
Executive summary:

Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 1250 mg/kg bw. Hence,LD50 value was considered to be 1250 mg/kg bw(95% CI: 8200-189000),when rats were treated with test chemical orally.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 250 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer reviewed journal

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Quality of whole database:
Waiver

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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 peer-reviewed journal
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute dermal toxicity test was carried out to study the effects of test chemical on rabbits.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Type of coverage:
other: Dermal
Vehicle:
not specified
Details on dermal exposure:
not specified
Duration of exposure:
not specified
Doses:
6000 mg/kg
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:
> 6 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed in treated rabbits at 6000 mg/kg bw
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
other: not classified
Conclusions:
The LD50 value was considered to be >6000 mg/kg bw,when ratbbits were treated with test chemical by dermal application.
Executive summary:

In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 6000 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 6000 mg/kg bw.Therefore, LD50 value was considered to be >6000 mg/kg bw,when rabbits were treated with test chemical by dermal application.  

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
6 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer reviewed journal

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 –

The reported study was mentioned in authoritative database ,handbook ,peer reviewed journal,and secondary report to designed and conducted to determine the acute oral toxicity profile of the given test chemical. Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 1250 mg/kg bw. Hence,LD50 value was considered to be 1250 mg/kg bw(95% CI: 8200-189000),when rats were treated with test chemical orally.

The above study is supported with another study mentioned in authoritative database and conducted on rat for the test chemical. Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 1400 mg/kg bw. Hence,LD50 value was considered to be 1400 mg/kg bw,when rats were treated with test chemical orally.

Both the above studies are further supported with the study mentioned in authoritative database for the test chemical. Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 1231 mg/kg bw. Hence,LD50 value was considered to be 1231 mg/kg bw,when rats were treated with test chemical orally.

Thus, based on the above summarised study on test chemical, the LD50 value it can be concluded that LD50 value is between 300-2000 mg/kg bw. Therefore, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4 (300 – ≤ 2000)” for acute oral toxicity.

Acute Inhalation Toxicity:

Test chemicalhas very low vapour pressure (16.4 Pa= 0.1230101 mmhg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.

 

Acute Dermal toxicity:

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

The reported study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical in rabbits. In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 6000 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 6000 mg/kg bw.Therefore, LD50 value was considered to be >6000 mg/kg bw,when rabbits were treated with test chemical by dermal application.  

The above study is supported with another study conducted on rabbits for the test chemical. In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 5000 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 5000 mg/kg bw.Therefore, LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical by dermal application.  

Both the above studies are further supported with the study mentioned in authoritative database. In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 20000 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 20000 mg/kg bw.Therefore, LD50 value was considered to be 20000 mg/kg bw,when rabbits were treated with test chemical by dermal application.  

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 cannot be classified for acute dermal toxicity.

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 and >2000 mg/kg bw for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4 (300 – ≤ 2000)” for acute oral toxicity and cannot be classified for acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.