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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of study: October, 08, 1997 / End of study: October 22, 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 B.1 (Acute Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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 - liquid: suspension
- 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
- Certificate of analysis: lP 156.1 of August 19, 1997
- Physical state: white powder
- Lot/batch No.: TAM 40-96-13
- Date of production: August, 27, 1996
- Date of receiveding: August, 28, 1997
- Date of expiry: August 1998
- Storage conditions: darkness at approximately 5°C in a refrigerator
- Stability and homogeneity in the vehicle is guaranteed for 4 hours
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Body weight at start of study
male animals mean = 175 g (= 100 %)
s = ± 5 g
min = 167 g (- 4.6 %)
max = 180 g (+ 2.9 %)
n = 5
female animals mean = 170 g (= 100 %)
s = ± 6g
min = 163 g (- 4.1 %)
max = 177 g (+ 4.1 %)
n = 5
Age at the start of the study: male animals approximately 7 weeks
female animals approximately 8 weeks
Randomization : Randomization schemes 96.0520 and 97.0538
Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
Room temperature: 22 ± 3°C
Relative humidity: 50 ± 20%
Lighting time: 12 hours daily
Acclimatization: at least one day (breeding at identical conditions)
Food: ssniff R/M-H (V 1534), ad libitum
Withdrawal of food: from about 16 hours before to 3 - 4 hours after treatment
Water: tap water in plastic bottles, ad libitum
Animal identification: fur marking with KMn04 and cage numbering
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil (Oleum sesami DAB 10)
- Doses:
- The acute oral toxicity of Fexofenadonethylester was tested only at a dose level of 2000 mg/kg body weight.
The administration volume being 10 ml/kg body weight. - No. of animals per sex per dose:
- 5 per sex
- Control animals:
- not specified
- Details on study design:
- The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on week ends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: No symptoms were observed after administration of 2000 mg/kg body weight.
- Gross pathology:
- No visible changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results obtained in this study the median lethal dose value (LD50) of Fexofenadonethylester for the male and female rat is greater than 2000 mg/kg body weight.
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