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 for the given test chemical. The LD50 value is 3530 mg/kg bw. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. 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 low vapour pressure of the test chemical, which is reported to be 1.79E-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 study conducted on rabbits for the test chemical. The LD50 value is >5000 mg/kg bw. The study 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:
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 publication.
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity study was conducted by using the given test chemical in rodent.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Diet (e.g. ad libitum): food, ad libitum
- Water (e.g. ad libitum): water, ad libitum;
Route of administration:
oral: gavage
Vehicle:
other: Agar/Tween
Details on oral exposure:
not specified
Doses:
1.25 - 10 g/kg
No. of animals per sex per dose:
Total = 20
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed and dosed after a one-week observation.Rats were observed daily for 7 to 14 days.
- Necropsy of survivors performed: yes, animals were sacrificed and autopsied for gross pathology.
Statistics:
not specified
Preliminary study:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 530 mg/kg bw
Based on:
test mat.
Mortality:
50% mortality was observed at 3530 mg/kg bw.
Clinical signs:
Clinical signs was observed such as Ataxia.
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
other: Not classified
Conclusions:
Acute oral toxicity dose (LD50) value was considered to be 3530 mg/kg bw, when rats were treated with the given test chemical via oral route.
Executive summary:

The acute oral toxicity study was conducted by using the given test chemical in 20 rats at the dose concentration of 1.25 - 10 g/kg via oral route. The given test chemical was dissolved in Agar/Tween. The animals were weighed and dosed after a one-week observation. Rats were observed daily for 7 to 14 days, during which time food and water were allowed ad libitum; in some instances, animals were sacrificed and autopsied for gross pathology. 50% mortality was observed at 3530 mg/kg bw. Clinical signs was observed such as ataxia.

Hence, the LD50 value was considered to be 3530 mg/kg bw, when rats were treated with the given test chemical via oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 530 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:
study scientifically not necessary / other information available
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 is from publication.
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute dermal toxicity study was conducted by using the given test chemical in rodent.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rabbit
Strain:
other: albino
Sex:
not specified
Type of coverage:
other: Dermal
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: The test substance was applied to the epilated skin of the back or flanks
REMOVAL OF TEST SUBSTANCE
- Washing (if done): it was then washed off.
- Time after start of exposure: 18-24 hours
Duration of exposure:
18-24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total = 10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made daily for signs of toxicity and irritation.
- Necropsy of survivors performed: yes, animals were autopsied following the 5- to 7-day observation period.
Statistics:
not specified
Preliminary study:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 5000 mg/kg bw.
Clinical signs:
There were no gross signs of toxicity or irritation throughout the observation period;
Body weight:
not specified
Gross pathology:
Autopsy revealed one animal with congested kidneys.
Other findings:
not specified
Interpretation of results:
other: Not classified
Conclusions:
Acute dermal toxicity dose (LD50) value was considered to be >5000 mg/kg bw, when 10 albino rabbits were treated with the given test chemical via dermal route.
Executive summary:

The acute dermal toxicity study was conducted by using the given test chemical in 10 albino rabbits at the dose concentration of 5000 mg/kg bw. The test substance was applied to the epilated skin of the back or flanks and held in contact for 18-24 hours; it was then washed off. Observations were made daily for signs of toxicity and irritation. Animals were autopsied following the 5- to 7-day observation period. No mortality was observed at 5000 mg/kg bw. There were no gross signs of toxicity or irritation throughout the observation period. Autopsy revealed one animal with congested kidneys.

Hence, the LD50 value was considered to be >5000 mg/kg bw, when 10 albino rabbits were treated with the given test chemical via dermal route.

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 the given test chemical. The studies are summarized as below –

 

The reported study was mentioned in publication, handbook and different authoritative databases and conducted to assess the toxicological profile of the test chemical in 20 rats at the dose concentration of 1.25 - 10 g/kg via oral route. The given test chemical was dissolved in Agar/Tween. The animals were weighed and dosed after a one-week observation. Rats were observed daily for 7 to 14 days, during which time food and water were allowed ad libitum; in some instances, animals were sacrificed and autopsied for gross pathology. 50% mortality was observed at 3530 mg/kg bw. A clinical sign was observed such as ataxia. Hence, the LD50 value was considered to be 3530 mg/kg bw, when rats were treated with the given test chemical via oral route.

 

The above study is supported with another study mentioned in publication for the given test chemical. The acute oral toxicity study was conducted in 15 rats at the dose concentration of 2.5-10 g/kg via oral route. The given test chemical was dissolved in Water/agar/tween. The animals were weighed and dosed after a one-week observation. Rats were observed daily for 7 to 14 days, during which time food and water were allowed ad libitum; in some instances, animals were sacrificed and autopsied for gross pathology. 50% mortality was observed at 6150 mg/kg bw. Hence, the LD50 value was considered to be 6150 mg/kg bw, when 15 rats were treated with the given test chemical via oral route.

 

These studies are further supported with the data available in publication for the given test chemical. The acute oral toxicity study was conducted in 30 rats at the dose concentration of 0.2 - 6.4 g/kg via oral route. The given test chemical was dissolved in water. The animals were weighed and dosed after a one-week observation. Rats were observed daily for 7 to 14 days, during which time food and water were allowed ad libitum; in some instances, animals were sacrificed and autopsied for gross pathology. No mortality was observed at 6400 mg/kg bw. Hence, the LD50 value was considered to be >6400 mg/kg bw, when 30 rats were treated with the 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, for acute oral toxicity. 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 low vapour pressure of the test chemical, which is reported to be 1.79E-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 reported study was mentioned in publication and conducted by using the given test chemical in 10 albino rabbits at the dose concentration of 5000 mg/kg bw. The test substance was applied to the epilated skin of the back or flanks and held in contact for 18-24 hours; it was then washed off. Observations were made daily for signs of toxicity and irritation. Animals were autopsied following the 5- to 7-day observation period. No mortality was observed at 5000 mg/kg bw. There were no gross signs of toxicity or irritation throughout the observation period. Autopsy revealed one animal with congested kidneys. Hence, the LD50 value was considered to be >5000 mg/kg bw, when 10 albino rabbits were treated with the given test chemical via dermal route.

Justification for classification or non-classification

Based on the above studies for the test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity and acute dermal toxicity. Thus, comparing these values 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.