Registration Dossier
Registration Dossier
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EC number: 848-454-6 | CAS number: 1398610-04-2
Endpoint summary
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
- 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.
Reference
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.
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