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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sample reception: 31-10-1997 / Study completion date: 9-03-1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to internetional guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- tudy was performed in 1998, which is before the OECD guideline for the LLNA method was adopted (2002).
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): FEXOFENDONETHYLESTER
- Physical state: white powder
- Lot/batch No.: TAM 40/96/13
- Container: one plastic flask
- Date of receipt: 31 October 1997
- Storage condition of test material: at +4°C and protected from light
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Breeder: Charles River France, 76410 Saint-Aubin-les-Elbeuf, France.
Allocation of the animals to the groups: on day 1, the animals were weighed and randomly allocated to two groups: a control group 1consisting of 5 females and a treated group 2 consisting of 10 females.
Age: 3 months old
Weight at initiation: 348 ± 21g.
Acclimatization: at least 5 days before the beginning of the study.
Identification of the animals: ear-tattoo.
Environmental conditions
The conditions in the animal room were set as follows:
- temperature: 21 ± 2°C
- relative humidity: 30 to 70%
- light/dark cycle: 12h/12h
- ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and retained. During the acclimatization period and throughout the study, the animals were housed individually in polycarbonate cages (48cmx27cmx20cm) equipped with a polypropylene bottle.
Food and water
Food: free access to "106 pelleted diet" (U.A.R., 91360Villemoisson-sur-Orge,France).
Drinking water: filtered by a F.G.Millipore membrane (0.22 µ) was provided ad libitum.
No contaminants are known to be present in the diet, drinking water or bedding material at levels which may be expected to interfere with or prejudice the outcome of the study.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Remarks:
- The test substance was finely pulverised before being incorporated in the vehicle.
- Concentration / amount:
- Induction phase:
Intradermal:
Anterior site : FCA diluted at 50% (v/v) with 0.9% NaCl
Middle site: test substance at 0.1% (w/w) in parrafin oil
Posterior site: test substance at 0.1% (w/w) in a mixture FCA /0.9% NaCl 50/50 (v/v)
Cutaneous route:
application of 0.5 ml of the test substance at the concentration of 20% (w/w) under an occlusive dressing for 48h.
Challenge phase: application of 0.5 ml of the test substance at the concentration of 20% (w/w) under an occlusive dressing for 24h.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Remarks:
- The test substance was finely pulverised before being incorporated in the vehicle.
- Concentration / amount:
- Induction phase:
Intradermal:
Anterior site : FCA diluted at 50% (v/v) with 0.9% NaCl
Middle site: test substance at 0.1% (w/w) in parrafin oil
Posterior site: test substance at 0.1% (w/w) in a mixture FCA /0.9% NaCl 50/50 (v/v)
Cutaneous route:
application of 0.5 ml of the test substance at the concentration of 20% (w/w) under an occlusive dressing for 48h.
Challenge phase: application of 0.5 ml of the test substance at the concentration of 20% (w/w) under an occlusive dressing for 24h.
- No. of animals per dose:
- 10 treated females
5 controls - Positive control substance(s):
- yes
- Remarks:
- DNCB, Mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under our experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance FEXOFENDONETHYLESTER does not induce delayed contact hypersensitivity in guinea-pigs.
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