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Administrative data

Description of key information

Oral: Read across to Sarolaner API


Test article was evaluated for its acute oral toxicity potential in female albino rats when administered as a gavage dose by OECD 425. The acute oral LD50 was estimated to be 783 mg/kg.


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 through category approach
Justification for type of information:
Read across to Sarolaner API
Reason / purpose for cross-reference:
read-across source
Sex:
female
Dose descriptor:
LD50
Effect level:
783 mg/kg bw
Based on:
test mat.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute oral LD50 was estimated to be 783 mg/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
783 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 to Sarolaner API, OECD 425: LD50: 783 mg/kg body weight


Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1 , this substance should be classified as category 4 for acute oral toxicity.


 


Specific target organ toxicity-single exposure:


Oral:


Mortality occurred only at the 2000 mg/kg level. Clinical signs in one survivor included activity decrease, emaciation, decreased/no defecation, small/hard feces, piloerection, sensitivity to touch and staggered gait, on Days 3-9. Animals that died on test exhibited activity decrease, body tremors, crusted face, piloerection and small feces. Animals surviving to termination exhibited weekly weight gain, except for two that lost or failed to gain weight between days 0 and 7. Abnormal necropsy findings that occurred, only in the animals dying on test, pertained to fur, muzzle/tail areas, lungs, liver and contents of the stomach/intestines.


As there were no effects considered to support classification for Category 1 and 2 observed. Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1 and 3.8.2, this substance should be not classified.