Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The 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 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 6.61E-009 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the test chemical. The 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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on two acute oral toxicity studies as- WoE 2 and WoE 3.
Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Test material information:
Composition 1
Species:
other: 1. mouse 2. rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
1. not specified
2. not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
1. not specified
2. not specified
Doses:
1. 2400 mg/kg bw
2. 5000 mg/kg bw
No. of animals per sex per dose:
1. not specified
2. not specified
Control animals:
not specified
Details on study design:
1. not specified
2. not specified
Statistics:
1. not specified
2. not specified
Preliminary study:
1. not specified
2. not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
1. 50% mortality was observed
2. No mortality was observed.
Clinical signs:
1. not specified
2. not specified
Body weight:
1. not specified
2. not specified
Gross pathology:
1. not specified
2. not specified
Other findings:
1. not specified
2. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the test chemical cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

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 and mice for test chemical. The studies are summarized as below –

1. The acute oral toxicity study was conducted by using test chemical in mice at the concentration of 2400 mg/kg bw. 50% mortality was observed at 2400 mg/kg bw. Hence, LD50 value was considered to be 2400 mg/kg bw, when mice were treated with given test chemical via oral route.

2. The acute oral toxicity study was conducted by using test chemical in rats at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Hence, LD50 value was considered to be >5000 mg/kg bw, when rats were treated with given test chemical via oral route.

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 oral toxicity.

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

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on two acute dermal toxicity studies as- WoE 2.and WoE 3.
Acute dermal toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
other: 1. not specified 2. New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
1. not specified
2. not specified
Type of coverage:
other: Dermal
Vehicle:
not specified
Details on dermal exposure:
1. not specified
2. not specified
Duration of exposure:
1. not specified
2. not specified
Doses:
1. 2000 mg/kg bw
2. 2000 mg/kg bw
No. of animals per sex per dose:
1. not specified
2. not specified
Control animals:
not specified
Details on study design:
1. not specified
2. not specified
Statistics:
1. not specified
2. not specified
Preliminary study:
1. not specified
2. not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
1. No mortality was observed at 2000 mg/kg bw.
2. No mortality was observed at 2000 mg/kg bw.
Clinical signs:
1. not specified
2. not specified
Body weight:
1. not specified
2. not specified
Gross pathology:
1. not specified
2. not specified
Other findings:
1. not specified
2. not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation, the test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

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 –

1. The acute dermal toxicity study was conducted by using test chemical in rabbits at the concentration of 2000 mg/kg bw. No mortality was observed at 2000 mg/kg bw. Hence, LD50 value was considered to be >2000 mg/kg bw, when rabbits were treated with given test chemical by dermal application.

2. The acute dermal toxicity study was conducted by using test chemical in New Zealand White rabbits at the concentration of 2000 mg/kg bw. No mortality was observed at 2000 mg/kg bw. Hence, LD50 value was considered to be >2000 mg/kg bw, when New Zealand White rabbits were treated with given 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.

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

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 and mice for test chemical. The studies are summarized as below –

1. The acute oral toxicity study was conducted by using test chemical in mice at the concentration of 2400 mg/kg bw. 50% mortality was observed at 2400 mg/kg bw. Hence, LD50 value was considered to be 2400 mg/kg bw, when mice were treated with given test chemical via oral route.

2. The acute oral toxicity study was conducted by using test chemical in rats at the concentration of 5000 mg/kg bw. No mortality was observed at 5000 mg/kg bw. Hence, LD50 value was considered to be >5000 mg/kg bw, when rats were treated with given test chemical via oral route.

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 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 6.61E-009 Pa. 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 rabbits for test chemical. The studies are summarized as below –

1. The acute dermal toxicity study was conducted by using test chemical in rabbits at the concentration of 2000 mg/kg bw. No mortality was observed at 2000 mg/kg bw. Hence, LD50 value was considered to be >2000 mg/kg bw, when rabbits were treated with given test chemical by dermal application.

2. The acute dermal toxicity study was conducted by using test chemical in New Zealand White rabbits at the concentration of 2000 mg/kg bw. No mortality was observed at 2000 mg/kg bw. Hence, LD50 value was considered to be >2000 mg/kg bw, when New Zealand White rabbits were treated with given 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 >2000 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.