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Administrative data

Description of key information

Acute oral toxicity: 

In acute oral toxicity study, rat were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality was observed at 5000 mg/kg bw in treated rat. Therefore, LD50 was considered to be > 5000 mg/kg bw when rats were treated with test chemical orally.

 

Acute Inhalation Toxicity:

 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.01425 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal toxicity:

In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality was observed at 5000 mg/kg bw in treated rabbits. Therefore, LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with test chemical dermally.

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 peer-reviewed journal
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity study oftest chemical in rat.
GLP compliance:
not specified
Test type:
other: Not specified
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
5000 mg/kg
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50 % Mortality observed
Mortality:
No mortality was observed at 5000 mg/kg bw
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: Not classified
Conclusions:
LD50 was considered to be > 5000 mg/kg bw when rats were treated with test chemical orally.
Executive summary:

In acute oral toxicity study, rat were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality was observed at 5000 mg/kg bw in treated rat. Therefore, LD50 was considered to be > 5000 mg/kg bw when rats were treated with test chemical orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from publication

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:
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 s from peer- reviewed journal
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute dermal toxicity study of test chemical in rabbit.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Type of coverage:
other: Dermal
Vehicle:
not specified
Details on dermal exposure:
No data available
Duration of exposure:
No data available
Doses:
5000 mg/kg
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed in treated rat at 5000 mg/kg bw
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: Not classified
Conclusions:
LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with test chemical dermally.
Executive summary:

In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality was observed at 5000 mg/kg bw in treated rabbits. Therefore, LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with test chemical dermally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from publication

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 –

 

1) In acute oral toxicity study, rat were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality was observed at 5000 mg/kg bw in treated rat. Therefore, LD50 was considered to be > 5000 mg/kg bw when rats were treated with test chemical orally.

 

2) Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for with test material. The LD50 was estimated to be 7300 mg/kg bw with Reliability Index 0.82 ( ; >0.75 = high prediction quality.), when rats were treated with test material via oral route.

 

3) Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of >5000 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. No mortality observed at the dose of 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rats were treated with test chemical via oral route.

 

4) Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 8400 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. 50% mortality observed at the end of the study. Therefore, LD50 value was considered to be 8400 mg/kg bw, when rats were treated with test chemical via oral route.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >5000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

 

Acute Inhalation Toxicity:

 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.01425 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is 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 rats and rabbits for test chemical. The studies are summarized as below –

 

1. In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality was observed at 5000 mg/kg bw in treated rabbits. Therefore, LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with test chemical dermally.

 

2. Acute dermal toxicity study of test chemical was conducted on rats at the dose concentration of >5000 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. No mortality observed at the dose of 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rats were treated with test chemical via dermal application.

 

3. Acute dermal toxicity study of test material was conducted on rats at the dose concentration of >5000 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. No mortality observed at the dose of 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rats were treated with test material via dermal application.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >5000 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 >5000 mg/kg bw, for acute oral and acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral and acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.