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EC number: 616-391-1 | CAS number: 76812-02-7
- 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
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study of study: November 10, 1997 / End of study: November 14, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- yes
- Remarks:
- Principles of Good Laboratory Practice, annex of paragraph 19a, section 1of the chemical law
Test material
- Reference substance name:
- 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 616-391-1
- Cas Number:
- 76812-02-7
- Molecular formula:
- C34 H41 N O4
- IUPAC Name:
- 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- Reference substance name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- IUPAC Name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Fexofenadonethylester
- Synonyms: Terfenadonethylester
- Chemical name: 4-[4-[4-hydroxydiphenylmethyl-1-piperidinyl]-1- oxobutyl]-a.,a.-dimethylbenzeneacetic acid ethyl ester
- Purity: 98.65%
- Certificate of analysis: Analysenbefund lP 156.1 from August 19, 1997
- Lot/batch No.: TAM 40-96-13 from August 27, 1996
- Appearance: white powder
- Date of production: August 27, 1996
- Date of receiving: August 28, 1997
- Date of expiry: August 1998
- Storage condition of test material: darkness at approximately 5 °C in a refrigerator under dry conditions
- Solubility in water: not soluble
Constituent 1
Constituent 2
Test solutions
- Vehicle:
- no
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Origin: Hoechst Marion Roussel Deutschland GmbH Global Preclinical Development - Drug Safety
Date of hatching: August 04, 1997
Delivery date: September 24, 1997
The fish were kept for 14 days before the start of the study in water for dilution under the following conditions:
- Temperature: 22 ± 1 °C
- Oxygen content: >= 80 % of the saturation value
- Duration of light period: 12 hours daily
-Population density: <= 1g fish / L water
- Feeding: twice daily ad libitum
-Food: Tetra Min, Tetra Werke, Melle (Germany)
The body length of 7 representative fish from each batch was measured.
Body lenght (cm): Variation range: 2.5 - 3.2 / mean: 2.7 / s: ± 0.26
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- 2.1 -2.3 mmol Ca2+ + Mg2+/L during the study.
- Test temperature:
- The temperature of the water bath was regulated by a thermostat to 22 ± 1 °C.
- pH:
- The pH was measured before the use of each study batch. lt was in a range of 8.2- 8.3.
- Dissolved oxygen:
- The dilution water was prepared as described and was aerated until oxygen saturation.
- Nominal and measured concentrations:
- 0 /100 mg/L (nominal concentration)
0 /11.3 mg/L (mean measured concentration) - Details on test conditions:
- The test chambers, which were calibrated to 4 liters, were made of glass (length 20 cm, width 15 cm, height 20 cm) and stood in a water bath made of Hostalit Z® with a Plexiglas viewing panel. The chambers were illuminated from above from 06.00 a.m to 06.00 p.m. The light intensity directly over the chambers was approximately 700 lux.
The test chambers were not aerated during the course of the study.
Results and discussion
Effect concentrations
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- The 100 mg/L group exhibited symptoms but no lethality.
The fish showed changes in behavior, swimming behavior and respiration rate. Symptoms occurred during the entire exposure time.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of this test the LC50 of Fexofenadonethylesterafter 96 hours was > 100 mg/L (based on nominal concentration). No lethality occured up to the solubility limit of the test substance in the test water.
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