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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 2900 mg/kg bw. The study 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 the low vapour pressure of the test chemical, which is reported to be 0.0072 Pa (5.4004433e-5 mm Hg). 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 >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
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute oral toxicity dose for the substance was determined in rats.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
10% suspension in 0.5% carboxymethylcellulose
Details on oral exposure:
not specified
Doses:
2900 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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 900 mg/kg bw
Based on:
test mat.
95% CL:
2 400 - 3 400
Mortality:
50% mortality was observed at 2900 mg/kg bw in treated animals.
Clinical signs:
other: not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
other: Not classified
Conclusions:
The acute oral LD50 value was determined to be 2900 mg/kg bw, with 95% confidence limit of 2400-3400 mg/kg bw, when male and female CFY rats were treated with the given test substance via oral gavage route.
Executive summary:

The acute oral toxicity study was conducted by using of the given test chemical inmale and female CFY rats at the dose concentration of 2900 mg/kg bw.

The given test chemical was prepared as 10% suspension in 0.5% carboxymethylcellulose and administered via oral route.

The animals were observed for mortality. 50% mortality was observed at 2900 mg/kg bw in treated animals.

Hence, the LD50 valuewas determined to be 2900 mg/kg bw, with 95% confidence limit of 2400-3400 mg/kg bw, when male and female CFY rats were treated with the given test substance via oral gavage route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 900 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:
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 for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 3 acute dermal toxicity studies as- WoE 2, WoE 3 and WoE 4.
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
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
1. not specified
2. not specified
3. not specified
Type of coverage:
other: Dermal
Vehicle:
not specified
Details on dermal exposure:
1. not specified
2. not specified
3. not specified
Duration of exposure:
1. not specified
2. not specified
3. not specified
Doses:
1. 5000 mg/kg bw
2. 5000 mg/kg bw
3. 5000 mg/kg bw
No. of animals per sex per dose:
1. not specified
2. not specified
3. not specified
Control animals:
not specified
Details on study design:
1. not specified
2. not specified
3. not specified
Statistics:
1. not specified
2. not specified
3. not specified
Preliminary study:
1. not specified
2. not specified
3. not specified
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
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
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:
1. No mortality was observed in treated rabbits at 5000 mg/kg bw
2. No mortality was observed at 5000 mg/kg bw.
3. No mortality was observed in trreated rabbits at 5000 mg/kg bw
Clinical signs:
other: 1. not specified 2. not specified 3. not specified
Gross pathology:
1. not specified
2. not specified
3. not specified
Other findings:
1. not specified
2. not specified
3. 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 >5000 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 –

 

The acute dermal toxicity study was conducted by using the given test chemical in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 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 mentioned in publication and database for the test chemical. The acute dermal toxicity study of test chemical was conducted on rabbits at the dose concentration of 5000 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death. No mortality was observed at a dose level of 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical via dermal application.

 

Both the above studies are further supported with the study mentioned in publication. In an acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 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.

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

 

The acute oral toxicity study was conducted by using of the given test chemical in male and female CFY rats at the dose concentration of 2900 mg/kg bw. The given test chemical was prepared as 10% suspension in 0.5% carboxymethyl cellulose and administered via oral route. The animals were observed for mortality. 50% mortality was observed at 2900 mg/kg bw in treated animals. Hence, the LD50 value was determined to be 2900 mg/kg bw, with 95% confidence limit of 2400-3400 mg/kg bw, when male and female CFY rats were treated with the given test substance via oral gavage route.

 

The above study is supported with another study mentioned in review article, publication and secondary source for the given test chemical. The acute oral toxicity study was conducted by using of the given test chemical in CD-albino mice at the dose concentration of 5300 mg/kg bw. The animals were observed for mortality. 50% mortality was observed at 5300 mg/kg bw in treated animals. Hence, the LD50 value was determined to be 5300 mg/kg bw, when CD-albino mice were treated with the given test substance via oral gavage route.

 

These studies are supported with the study mentioned in handbook and authoritative database for the test chemical. The acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 3300 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death. 50% mortality was observed at a dose level of 3300mg/kg bw. Therefore, LD50 value was considered to be 3300 mg/kg bw, when rats were treated with test chemical via oral route.

All the above studies are further supported with the study mentioned in publication and database for the test chemical. The acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 3180 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death. 50% mortality was observed at a dose level of 3180 mg/kg bw. Therefore, LD50 value was considered to be 3180 mg/kg bw, when rats were treated with test chemical orally.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that 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 0.0072 Pa (5.4004433e-5 mm Hg). 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 –

 

The acute dermal toxicity study was conducted by using the given test chemical in rabbits at the concentration of 5000 mg/kg bw. No mortality was observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 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 mentioned in publication and database for the test chemical. The acute dermal toxicity study of test chemical was conducted on rabbits at the dose concentration of 5000 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death. No mortality was observed at a dose level of 5000 mg/kg bw. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with test chemical via dermal application.

 

Both the above studies are further supported with the study mentioned in publication. In an acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality observed in treated rabbits at 5000 mg/kg bw. Therefore, LD50 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.