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Administrative data

Description of key information

Oral: Read across from Sarolaner step 2


The oral LD50 value of test item in Wistar Han rats was established to exceed 2000 mg/kg body weight according to the OECD 423.


Dermal: No data available


Inhalation: No data available

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across based on structural similarity
Justification for type of information:
Read across from Sarolaner step 2
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 was estimated to be greater than 2000 mg/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
2 (reliable with restriction)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Acute toxicity:


Oral, read across data, OECD 423: LD50> 2000 mg/kg body weight.


Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1 , this substance should not be classified for acute oral toxicity.


 


Specific target organ toxicity-single exposure:


Oral:


Mortality not occurred;and no abnormal necropsy findings occurred.


Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1 and 3.8.2, this substance should not be classified.