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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
- Principles of method if other than guideline:
- Single administration of four concentrations, occlusively applied to the intact clipped skin for an exposure period of 24 hours and an observation period of 14 days.
- GLP compliance:
- no
- Remarks:
- GLP-like, deviations: the experimental procedure was not inspected by QA, stability of the test substance in the application formulation was not analytically examined
- Test type:
- other: acute dermal toxicity
- 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, purity 97%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Cremophor EL
- Duration of exposure:
- 24 h
- Doses:
- 100, 500, 1000 and 2000 mg/kg
- No. of animals per sex per dose:
- 5
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 451 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 100 - < 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 918 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 462 - 1 829
Any other information on results incl. tables
At 2000 mg/kg local inflammation was seen at the application site.
Clinical signs at 500 mg/kg and/or above included piloerection, palor, sedation, sunken flanks, nasal discharge, bloody muzzle, and increased salivation. Onset of symptoms was 1 h post administration, on day 13 all survivors were free of signs.
Death occurred from day 5 until day 10 after administration. Necropsy of dead animals showed peritonitis with proliferations and fibrinously coated abdominal organs. In some animals the abdominal cavity and the thoracic cavity were filled with serous fluid.
At final necropsy small intestined adhered to the peritoneum in a 2000 mg/kg female, all other survivors showed no pathological changes.
Applicant's summary and conclusion
- Executive summary:
The acute dermal toxicity of Acemetacin-tert.-butylester was determined in male and female rats after single administration of four concentrations occlusively to intact clipped skin with an exposure period of 24 h and an observation period of 14 d.
The acute derml LD50for males was 1451 mg/kg and for females > 100 < 500 mg/kg. The LD50for both sexes is 918 mg/kg.
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