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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 test chemical. The LD50 value is 6400 mg/kg bw. The study concluded that LD50 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 4.98E-9 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 accordance with ANNEX VII column 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C). The experimental pH of the test chemical is 1.77. Hence, based on the low pH of the test chemical, the acute dermal study was considered for waiver.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
Data is from Danish QSAR.
Qualifier:
according to
Guideline:
other: Predicted data
Principles of method if other than guideline:
Data is predicted using the Danish (Q)SAR Database
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:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
6400 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
Sex:
not specified
Dose descriptor:
LD50
Effect level:
6 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality observed
Mortality:
not specified
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
other: Not classified
Conclusions:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 6400 mg/kg bw, when rats were treated with the given test chemical orally.
Executive summary:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for the given test chemical. The LD50 was estimated to be 6400 mg mg/kg bw with Reliability Index of 0.74 0.5-0.75 = moderate prediction quality, when rats were treated with the given test chemical orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 400 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from prediction report.

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
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint conclusion
Quality of whole database:
Waiver

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 -

 

Based on the QSAR prediction done using the Danish (Q)SAR Database, the acute oral toxicity was estimated for the given test chemical. The LD50 was estimated to be 6400 mg mg/kg bw with Reliability Index of 0.74 0.5-0.75 = moderate prediction quality, when rats were treated with the given test chemical orally.

 

The above prediction is supported with another study mentioned in authoritative databases for the given test chemical. The study was conducted in rats at the dose concentration of 3480 mg/kg bw. Animals were observed for mortality. 50% mortality was observed at 3480 mg/kg bw in treated animals. Hence, LD50 value was considered to be 3480 mg/kg bw, when rats were treated with the given test chemical via oral route.

 

These studies are supported with the data available in authoritative database for the test chemical. The acute oral toxicity study was conducted in rats at the dose concentration of 8480 mg/kg bw. Animals were observed for mortality. 50% mortality was observed at 8480 mg/kg bw in treated animals. Hence, LD50 value was considered to be 8480 mg/kg bw, when rats were treated with the given test chemical via oral route.

 

All the above studies are further supported with the study mentioned in study report for the given test chemical. The reported study was designed and conducted to determine the acute oral toxicity profile of the given test chemical as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) in Sprague Dawley rats.

Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing.

No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of  2000 mg/kg of the test item (Step - II).

Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.

Under the condition of the study, the acute oral LD50 value was considered to be >2000 mg/kg bw for the test chemical. Thus, it was concluded that the acute toxicity study of the given test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP.

 

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 4.98E-9 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 accordance with ANNEX VII column 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C). The experimental pH of the test chemical is 1.77. Hence, based on the low pH of the test chemical, the acute dermal study was considered for waiver.

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 toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. For acute inhalation toxicity and acute dermal toxicity wavier were added so, not possible to classify.