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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Male and female rats were treated with indomethacin in powdered diet for 8 weeks. Indomethacin was investigated in order to determine the level showing minimal toxicity, for use as a positive control in a long term study for a related test substance.
- GLP compliance:
- 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
Test animals
- Species:
- rat
- Strain:
- other: (CFY (derived fromSprague-Dawley strain) from Anglia Laboratory Animals, Alconbury,England)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 8 weeks
- Frequency of treatment:
- daily (continously via feed)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3.4-5.2-6.9 and 8.6 mg/kg bw/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
|
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Endpoint |
Findings |
Sex |
at Dose |
|
|
|
|
Mortality |
- 2 M, 4 F died at 5.2 mg/kg bw/day; all animals died at ≥ 6.9 mg/kg bw/day (mainly during the first 3 weeks of treatment) |
M, F |
≥ 5.2 |
Clinical signs |
- yellow brown staining of fur in urogenital region - swelling of abdomen - poor general condition before death/sacrifice in extremis |
M, F |
≥ 5.2 |
Food consumption |
- reduced towards controls (only marginal in F of the 3.4 mg/kg dose group) - inferior efficiency of food utilisation |
M, F
M, F |
≥ 3.4
8.6 |
Body weight |
- slight to marked depression of body weight gain (decedents: partly body weight loss) |
M F |
≥ 5.2 ≥ 3.4 |
Necropsy |
- decedents: fibrous adhesion between all levels of the GI tract, sometimes involving other viscera and abdominal wall, enlargement and pallor of spleen, copious serous fluid in abdominal cavity (ascites) - animals surviving up to completion of study: moderate intestinal adhesion and enlargement of spleen (one F at 3.4 mg/kg) |
M, F
M F |
≥ 5.2
≥ 5.2 ≥ 3.4 |
Organ weights |
- higher absolute weight and organ-to-body weight ratio of spleen |
M, F |
5.2 |
|
- higher absolute weight and organ-to-body weight ratio of liver |
F |
5.2 |
|
- higher absolute weight and organ-to-body weight ratio of adrenals |
M F |
≥ 3.4 5.2 |
|
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M: Males; F: Females; GI tract: gastrointestinal tract |
Applicant's summary and conclusion
- Executive summary:
Male and female rats were treated with indomethacin in powdered diet for 8 weeks at dose levels of 3.4-5.2-6.9 and 8.6 mg/kg bw/day . Indomethacin was investigated in order to determine the level showing minimal toxicity, for use as a positive control in a long term study for a related test substance. In both gender dosing at 5.2 mg/kg and above caused clinical symptoms (yellow brown staining of fur, swollen abdomen), mortality, impaired body weight gain (in females already at 3.4 mg/kg), gross pathological lesions (fluid and adhesions in peritonal cavity indicating peritonitis, enlarged spleen in one female already at 3.4 mg/kg) and increased absolute and relative organ weights (spleen, liver, adrenals (in males already at 3.4 mg/kg)).
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