Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Oral: Read across from 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
- 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 API
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 783 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other:
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral LD50 was estimated to be 783 mg/kg.
Reference
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 from 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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