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EC number: 200-186-5 | CAS number: 53-86-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity studies with indomethacin were performed by oral dosing (gavage, capsule, feed) in different species (rat, dog, monkey) for different time frames (from 21 days to 52 weeks).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- Study duration:
- subchronic
- Species:
- rat
Additional information
After repeated exposure to Indomethacin typical effects for NSAIDs (non-steroidal anti-inflammatory drugs) related to its pharmacological mode of action (inhibition of prostaglandin synthesis) are observed. Prominent findings in animal experiments comprised gastrointestinal alterations (e.g. gastrointestinal ulcers, ascites, peritonitis) and effects on the kidneys (papillary necrosis in rats). Sequelae presented as clinical symptoms, impaired body weight gain, anemia, extramedullary hematopoiesis, increased spleen/adrenal and liver weight, impaired hematology and clinical chemistry parameters and mortality. Daily doses of 3.4 mg/kg bw and above were lethal in rats (subchronic feeding study). In dogs no relevant adverse effects were seen at subchronic dosing of 1 mg/kg bw.
As therapeutic doses in humans 75 - 150 mg/day divided in 3 -4 doses for a duration of 7 -14 days are quoted. Adverse reactions at therapeutic doses and seen at an incidence of greater than 1% are nausea with or without vomiting, dyspepsia, diarrhea, abdominal distress or pain, constipation, headache, dizziness, vertigo, somnolence, depression, fatigue and tinnitus.
Side effects of therapy with NSAIDs may be cardiovascular thrombotic events, hypertension (onset or worsening), congestive heart failure and edema, gastrointestinal effects (ulceration, bleeding, perforation), renal toxicity, anaphylactic/anaphylactoid reactions, skin reactions (e.g. exfoliative dermatitis, Steven-Johnson syndrome, toxic epidermal necrolysis), ocular effects (after prolonged therapy), central nervous effects (aggravate depression, psychiatric disturbances, epilepsy, and parkinsonism), elevation of liver enzymes (rare cases of fatal fulminant hepatitis), anemia, may aggravate pre-existing asthma; when given at the end of pregnancy: premature closure of ductus arteriosus.(cited from Physicians Desk Reference 2010 for Indocin(R) - www.pdrel.com)
Justification for classification or non-classification
Classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required as findings are triggered by the mode of action which is covered by classification of acute toxicity.
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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