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, 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:

Test chemicalhas very low vapour pressure (11.45 Pa.= 0.00859 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:
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 peer- reviewed journal
Qualifier:
according to guideline
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 or test system and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
4600 mg/kg bw
No. of animals per sex per dose:
10
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:
4 600 mg/kg bw
Based on:
test mat.
95% CL:
>= 4 200 - <= 5 000
Remarks on result:
other: 50 % mortality observed
Mortality:
50 % mortality observed in treated rats.
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:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be 4600 mg/kg bw (95% Confidence interval: 4200-5000),when ten rats were treated with test chemical orally.
Executive summary:

Acute oral toxicity study was performed in ten rats using test chemical at dose concentration of 4600 mg/kg bw.50% mortality was observed at dose 4600 mg/kg bw. Hence,LD50 value was considered to be 4600 mg/kg bw(95% Confidence interval: 4200-5000),when rats were treated with test chemical orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 600 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:
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 peer reviewed journal
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute dermal toxicity study of test chemical in rabbits
GLP compliance:
not specified
Test type:
other: No data
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system 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:
5 ml/kg (5000 mg/kg bw )
No. of animals per sex per dose:
4
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 were observed in treated rabbits 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:
The LD50 value was considered to be >5000 mg/kg bw,when rabbits 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 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.  

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 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, review article and peer reviewed journal to designed and conducted to determine the acute oral toxicity profile of the given test chemical. Acute oral toxicity study was performed in ten rats using test chemical at dose concentration of 4600 mg/kg bw.50% mortality was observed at dose 4600 mg/kg bw. Hence,LD50 value was considered to be 4600 mg/kg bw(95% Confidence interval: 4200-5000),when rats were treated with test chemical orally.

The above study is supported with another study mentioned in publication and conducted on rat for the test chemical. In a acute oral toxicity study,rats were treated with test chemical in the concentration of 3970, 4470 and 4970 mg/kg bw orally via gavage and observed for 14 days.7 animals died at 4970 mg/kg, 4 animals at 4470 mg/kg bw and 2 animals at 3970 mg/kg bw. Therefore,LD50 was considered to be 4570 (95% CI :4170–4970) mg/kg bw,when rats were treated with test chemical orally via gavage.

Both the above studies are further supported with the study mentioned in authoritative database ,handbook, review article and peer reviewed journal and secondary report for the test chemical. Acute oral toxicity study was performed in groups of 10 young adult Osborne-Mendel rats evenly divided by sexusing test chemical at dose concentration of 2330 mg/kg bw.All doses were given by intubation. All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks. LD50's were computed by the method of Litchfield & Wilcoxon (1949).The substance was a liquid and it was administered undiluted.50% mortality was observed at dose 2330 mg/kg bw.Clinical signs like somnolence (general depressed activity), Scrawny appearance, tremors at higher doses were observed. Hence,LD50 value was considered to be 2330 mg/kg bw (1940-2800) with 95% confidence limits,when rats were treated withtest chemical orally.

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:

Test chemicalhas very low vapour pressure (11.45 Pa.= 0.00859 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 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.  

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 4970 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 4970 mg/kg bw.Therefore, LD50 value was considered to be >4970 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 peer reviewed journal ,authoritative database and secondary report. In acute dermal toxicity study, five rabbits were treated with test chemical in the concentration of 5000 mg/kg bw by dermal application followed by a 14 days observation period.No mortality was observed in treated rabbits at dose 5000 mg/kg bw. Necropsy was not conducted. Therefore, LD50 value was considered to be >5000 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 >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.