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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
Endpoint summary
Administrative data
Description of key information
Oral (Rat-Wistar, GLP-like): LD50 males = 67 mg/kg, LD50 females = > 25 < 50 mg/kg; LD50 both sexes approx. 36 mg/kg
[Bayer AG, Report No. 18004, 1989-05-16]
Dermal (Rat-Wistar, GLP-like): LD50 males = 1451 mg/kg, LD50 females = > 100 < 500 mg/kg; LD50 both sexes 918 mg/kg
[Bayer AG, Report No. 15809, 1987-05-22]
A further non-GLP, non-Guideline study was conducted in male Wistar rats with a single oral administration of 108 mg/kg TVX 3934 (equivalent to Acemetacin-tert.-butylester) by gavage. TVX 3934 was suspended in Traganth (application volume 5 ml/kg) or Lutrol (application volume 10 ml/kg) and 10 animals per solvent were used. No animal died after administration of TVX 3934 in Traganth and one animal died after administration of TVX 3934 in Lutrol. No LD50 could be defined in this study.
[Troponwerke, Scientific Report No. 51138 F, 1987-03-23]
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 36 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 918 mg/kg bw
Additional information
The acute oral and the acute dermal toxicity of Acemetacin-tert.-butylester was studied in male and female rats in two GLP-like studies to define LD50 -values.
In these studies the acute oral LD50 for both sexes was determined to be approximately 36 mg/kg and the acute dermal LD50 for both sexes was determined to be approximately 918 mg/kg, whereas females seemed to be more susceptible.
In a further study in male rats with single oral application of 108 mg/kg TVX 3934 suspended in Traganth or Lutrol in male rats no mortality was observed in rats treated with TVX 3934 in Traganth and one animal died on day 8 after administration of TVX 3934 in Lutrol. 4/10 animals treated orally with TVX 3934 in Traganth showed ptosis 4 to 6 hours after administration, on the next the no clinical signs could be observed. All animals treated orally with TVX 3934 in Lutrol showed diarrhoe on the first day after administration. In 7/10 animals bloody noses and eyelids were observed on day 2 and 3 after administration and 6/10 animals showed e.g. ruffled fur up to 9 days after administration. From day 10 after administration onwards all surviving animals were without clinical signs.
Justification for classification or non-classification
Based on the study results Acemetacin-tert-butylester has to be classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) as toxic in contact with skin and if swallowed (T, R24/25) or as acute oral toxic, category 2 (H300) and acute dermal toxic, category 3 (H311), respectively.
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