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EC number: 616-210-6 | CAS number: 75302-98-6
- 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:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
- Principles of method if other than guideline:
- Single administration of six concentrations with an application volume of 10 ml/kg to fasted rats (5 males and 5 females) via stomach tube with an observation period of 14 days.
- GLP compliance:
- yes
- Remarks:
- the study was not planned as GLP-study but was conducted according to the GLP-principles; deviation: the experimental procedure was not inspected by QA
- Test type:
- other: acute oral toxicity, rat
- Limit test:
- no
Test material
- Reference substance name:
- 2-(tert-butoxy)-2-oxoethyl 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetate
- EC Number:
- 616-210-6
- Cas Number:
- 75302-98-6
- Molecular formula:
- C25 H26 Cl N O6
- IUPAC Name:
- 2-(tert-butoxy)-2-oxoethyl 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetate
- Details on test material:
- Acemetacin-tert.-butylester, solid yellow powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Doses:
- 25, 50, 100, 160, 180 and 200 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 67 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 25 - < 50 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 36 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Clinical signs at 50 mg/kg and above included piloerection, nasal discharge, bloody muzzle, increased salivation, paleness, sunken flanks, sedation, laboured breathing and emaciation. Onset of symptoms was 1 h after administration, on day 13 signs had disappeared.
No symptoms occurred in males after dosage with 25 mg/kg. One female showed slight to moderate salivation lasting about 1 day after administration and ruffled fur.
The surviving animals of the 50 mg/kg dose group showed a significant reduction of body weight during the first week.
Death occurred from day 2 until day 9. Necropsy of dead animals showed findings including abdominal cavity filled with serous liquid, abdominal organs with multiple adhesions and fibrinoid coatings. No findings were observed at final necropsy.
Applicant's summary and conclusion
- Executive summary:
The acute oral toxicity of Acemetacin-tert.-butylester was determined in male and female rats after single administration of six concentrations with an application volume of 10 ml/kg via stomach tube with an observation period of 14 d.
The acute oral LD50 for males was 67 mg/kg and for females > 25 < 50 mg/kg. The LD50 for both sexes is approximately 36 mg/kg.
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