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Description of key information

In an acute oral toxicity study in mouse, a LD50 of 14300 mg/kg bw was determined (reference 7.2.1 -1).

In an acute oral toxicity study in dog, a LD50 of above 7000 mg/kg bw was determined (reference 7.2.1 -2).

In an acute oral toxicity study in monkey, a LD50 of above 7000 mg/kg bw was determined (reference 7.2.1 -3).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
other: Data collection
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Acute oral toxicity test
- Short description of test conditions: The test item was oraly administered to mice. The animals were observed for clinical effects or mortality.
GLP compliance:
not specified
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
14 300 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study in mouse, a LD50 of 14300 mg/kg bw was determined.
Endpoint:
acute toxicity: oral
Type of information:
other: Data collection
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Acute oral toxicity test
- Short description of test conditions: The test item was oraly administered to dogs. The animals were observed for clinical effects or mortality.
GLP compliance:
not specified
Species:
dog
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
>= 7 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study in dog, a LD50 of above 7000 mg/kg bw was determined.
Endpoint:
acute toxicity: oral
Type of information:
other: Data collection
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Acute oral toxicity test
- Short description of test conditions: The test item was oraly administered to dogs. The animals were observed for clinical effects or mortality.
GLP compliance:
not specified
Species:
monkey
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
>= 7 000 mL/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study in monkey, a LD50 of above 7000 mg/kg bw was determined.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
7 000 mg/kg bw
Quality of whole database:
Data from three different species are available which all show very low acute toxicity in older studies.

Additional information

There are data on acute oral toxicity of the test item in three different species (mouse, dog and monkey) available (reference 7.2.1 -1 to 7.2.1 -3). The determined LD50 in three different species (mouse: 14300 mg/kg bw, dog: 7000 mg/kg bw, monkey: 7000 mg/kg bw) exceeds the limit value of 2000 mg/kg bw by far and indicates a very low acute oral toxicity of the test item. Based on these information it is very likely, that a study according to OECD guideline 423 in rat will also result in a LD50 of above 2000 mg/kg bw. Following the principle of minimising/avoiding unnecessary animal testing, the performance of a new guideline study is not indicated. According to Regulation EC No 1907/2006, Annex XI available data are regarded as suitable to cover the endpoint 7.2.1 acute oral toxicity.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available data are suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the test item is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.