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Description of key information

Acute oral toxicity: Key study: The acute oral LD50 value of the test substance is 6500 mg/kg bw in rats.

Acute dermal toxicity: Key study: The acute dermal LD50 value of the test substance was >2000 mg/kg bw in rats.

Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.

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:
other: A scientific review (peer reviewed). No data on GLP.
Principles of method if other than guideline:
No data on test method
GLP compliance:
no
Species:
rat
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:
6 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mean value of 5800-7200 mg/kg bw
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance is 6500 mg/kg bw in rats
Executive summary:

According to the peer reviewed article, the acute oral LD50 value of the test substance is 6500 mg/kg bw in rats

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 500 mg/kg bw
Quality of whole database:
Key study with Klimisch score = 2

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:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.
Endpoint conclusion
Endpoint conclusion:
no study available

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:
other: A scientific review (peer reviewed). No data on GLP.
Principles of method if other than guideline:
No data on test method
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute dermal LD50 value of the test substance was >2000 mg/kg bw in rabbits.
Executive summary:

According to the peer reviewed article, the acute dermal LD50 value of the test substance was >2000 mg/kg bw in rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Key study with Klimisch score = 2

Additional information

Acute oral toxicity: Key study: According to the peer reviewed article, the acute oral LD50 value of the test substance is 6500 mg/kg bw in rats

Acute dermal toxicity: Key study: According to the peer reviewed article, the acute dermal LD50 value of the test substance is greater than 2000 mg/kg bw in rats

Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route.

Justification for classification or non-classification

Based on the available data (LD50 (oral) = 6500 mg/kg bw and LD50 (Dermal) > 2000 mg/kg bw), the substance is not classified for acute toxicity according to CLP Regulation (EC) no. 1272/2008.