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Diss Factsheets
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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- A compilation of LD50 values in newborn and adult animals
- Author:
- Goldenthal, EI
- Year:
- 1 971
- Bibliographic source:
- Toxicology and Applied Pharmacology, 18: 185-207
- Reference Type:
- publication
- Title:
- Some peculiarities observed in the course of the acute toxicity of indomethacin
- Author:
- Tanev, G
- Year:
- 1 974
- Bibliographic source:
- Trudove na Nauchnoizsledovatelskiya Khimikofarmatsevtichen Institut, Vol. 9: 275-282
- Reference Type:
- publication
- Title:
- Gastrointestinal effects and acute toxicity of suprofen
- Author:
- Niemegeers CJE et al.
- Year:
- 1 975
- Bibliographic source:
- Drug Research, 25: 1537 - 1542
- Reference Type:
- publication
- Title:
- Indomethacin: Lack of effect on lethality of endotoxin in rats
- Author:
- Reichgott, MJ et al.
- Year:
- 1 975
- Bibliographic source:
- Circulatory Shock, Vol. 2: 215-219
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 981
- Reference Type:
- review article or handbook
- Title:
- Clinical Toxicology of Commercial Products, 5th Edition
- Author:
- Gosselin, RE , RP Smith, HC Hodge (Editors)
- Year:
- 1 984
- Bibliographic source:
- Williams & Wilkins, Baltimore, USA, page II-402
- Reference Type:
- publication
- Title:
- A national validation study of the acute toxic class method - an alternative to the LD50 test
- Author:
- Schlede, U et al.
- Year:
- 1 992
- Bibliographic source:
- Archives of Toxicology, 66: 455-470
- Reference Type:
- publication
- Title:
- The effects of suprofen in rats with Mycobacterium butyricum-induced arthritis
- Author:
- Awouters, F et al.
- Year:
- 1 975
- Bibliographic source:
- Arzneimittelforschung, 25 (10): 1526 - 1537
Materials and methods
- Principles of method if other than guideline:
- (single) dosing of male and female rodents (mice, rats)
- GLP compliance:
- not specified
- Test type:
- other: acute toxicity, different species, different dose routes
- Limit test:
- no
Test material
- Reference substance name:
- Indometacin
- EC Number:
- 200-186-5
- EC Name:
- Indometacin
- Cas Number:
- 53-86-1
- Molecular formula:
- C19H16ClNO4
- IUPAC Name:
- 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid
Constituent 1
Administration / exposure
- Control animals:
- not specified
Results and discussion
Any other information on results incl. tables
Species (Strain) |
Route of Administration (Vehicle) |
Gender |
LD50 (mg/kg bw) |
Remarks |
Reference |
Rat (Sprague Dawley) |
Oral (n.s.) |
n.s. |
12 (10-14) |
|
Goldenthal (1971) |
Rat |
Oral |
n.s. |
3300 |
Pathogenetic mechanism for acute death: central origin |
Tanev (1974) |
Rat |
Oral (diet) |
n.s. |
2.42 (1.75 – 3.36) Calculated value from 14-day feeding study |
Indomethacin was used as comparator in a desease model (experimentally induced arthritis) and given in the feed (approximate daily doses of 0.04, 8.08, 0.16, 0.31, 0.63, 1.25, 2.5 and 5 mg/kg). 3 animals with adjuvant arthritis per dose group, treatment for 14 days |
Awouters et al. (1975) |
Rat |
Oral (n.s..) |
n.s. |
19 |
|
Niemegeers et al. (1975) |
Rat (Sprague Dawley) |
Oral (12% alcohol 0.6 M phosphate buffer pH8; final concentration 1.5 mg/mL) |
M |
> 10 mg/kg bw: (no mortality at 10 mg/kg) |
Post administration observation period: 24 hours |
Reichgott et al. (1975) |
Rat (Sprague Dawley) |
Oral |
M
F |
51.0 (38.7 – 67.8)
51.0 (38.7 – 67.8) |
Death within 2 to 6 days; clinical signs: decreased spontaneous movement, diarrhea, emaciation;: at necropsy: atrophy of thymus, gastrointestinal ulcers, ascites, perforation peritonitis, intestinal adhesion, swelling of adrenal and mesenterial lymph nodes |
Okubo, M. et al (1981) |
Rat/guinea pig |
Oral (n.s.) |
n.s. |
12 (in rats) to 540 (guinea pigs)
|
Toxic signs: decreased activity, moderate decrease in respiratory rate (all species except dogs), ulceration of gastrointestinal tract; in dogs blanching of gums, diarrhea, emesis, occult blood in feces. Humans after overdose (either 775 or 1550 mg): lethargic, stuporous, mildly confused, vital signs normal, complete recovery after 24 hours; gastrointestinal ulceration and hemorrhage are possible consequences but have not been describe in man |
Gosselin et al. (1984) |
Rat (Wistar) |
Oral (n.s.) |
M + F |
> 25 and < 200 (2 laboratories)
≤ 25 (4 laboratories) |
Validation study for Acute toxic class method, observation for at least 14 days after admin. (in 6 laboratories) Toxicity signs (seen in at least 2 of 6 laboratories): apathy, tremor, respiratory dyspnoe, cyanosis, hunched posture, diarrhoea; at necropsy: discoloration and congestion of liver, lung, kidneys and adrenals, edema of the lung, fibrinopurulent peritonitis, bloody imbibition of gastro-intestinal tract, partly with ulcers, ascites, hydrothorax |
Schlede et al. (1992) |
|
|
|
|
|
|
n.s. : not specified; M: male; F: female |
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.