Registration Dossier
Registration Dossier
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EC number: 200-186-5 | CAS number: 53-86-1
Endpoint summary
Administrative data
Description of key information
Numerous tests for acute toxicity (LD50) were performed in different species (rat, mouse, rabbit, guinea pig, hamster, dog, cat) and different routes of administration (oral, intravenous, subcutaneous, intraperitoneal, dermal, rectal).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 17.7 mg/kg bw
Additional information
Oral dosing of indomethacin via gavage in rats resulted in LD50 values between 12 - 51 mg/kg bw. The lethal dose after dermal administration in rats is reported to be > 250 mg/kg bw. Data on acute toxicity by inhalation are not available. The most sensitive species appears to be the rat. The lowest reported LD50 value for the rat (2.42 mg/kg bw p.o. - Awouters et al. 1975) is considered invalid for classification as it is a calculated value from a 14-day feeding study in rats with adjuvant arthritis.
Justification for classification or non-classification
Based on an oral LD50 value in rats < 25 mg/kg bw and above 5 mg/kg bw, indomethacin is classified as very toxic (T+) according to 67/548/EEC and as acute toxicity category 2 according to Regulation (EC) 1272/2008 (CLP).
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