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Diss Factsheets
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EC number: 807-751-0 | CAS number: 4057-31-2
- 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
Acute toxicity, oral: Weight of evidence: Based on the read-across approach, the oral LD50 of dextro alpha fenchyl acetate was >10000 mg/kg bw/day in rats and 9000 mg/kg bw/day in mice.
Acute toxicity, dermal: Key study: Based on the read-across approach, the dermal LD50 of dextro alpha fenchyl acetate was > 20000 mg/kg bw/day in rabbits.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The analogue isobornyl acetate which shares the same functional groups with dextro alpha fenchyl acetate also has comparable values for the relevant molecular properties. A scientific review (peer reviewed). No data on GLP.
- Principles of method if other than guideline:
- No data on the method.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Read-across from an analogue
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the read-across approach from experimental data on the analogue isobornyl acetate, the oral LD50 (rats) is greater than 10000 mg/kg/bw.
- Executive summary:
Based on the read-across approach from the analogue isobornyl acetate, the oral LD50 of dextro alpha fenchyl acetate in rats is greater than 10000 mg/kg/bw.
Reference
The data matrix is included in the reporting format attached.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- Two studies are available, both with Klimisch score = 2.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The analogue isobornyl acetate which shares the same functional groups with dextro alpha fenchyl acetate also has comparable values for the relevant molecular properties. A scientific review (peer reviewed). No data on GLP.
- Principles of method if other than guideline:
- No data provided on the method.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 20 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Read-across from an analogue
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the read-across approach from experimental data on the analogue isobornyl acetate, the dermal LD50 in rabbit is greater than 20000 mg/kg bw
- Executive summary:
Based on the read-across approach from the analogue isobornyl acetate, the dermal LD50 of dextro alpha fenchyl acetate in rabbits is greater than 20000 mg/kg bw.
Reference
The data matrix is included in the reporting format attached.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 20 000 mg/kg bw
- Quality of whole database:
- Study with Klimisch score = 2.
Additional information
Acute toxicity, oral:
Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the oral LD50 of dextro alpha fenchyl acetate in rats is greater than 10000 mg/kg/bw.
Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the LD50 of dextro alpha fenchyl acetate in mice (gavage) is 9000 mg/kg bw.
Acute toxicity, inhalation:
Data waiving (other justification): According to REACH Annex VIII, column 2, in addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. The information is provided for dermal route.
Acute toxicity, dermal:
Key study: Based on the read-across approach from the analogue isobornyl acetate, the dermal LD50 of dextro alpha fenchyl acetate in rabbits is greater than 20000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
The study performed in rats has been selected.
Justification for selection of acute toxicity – inhalation endpoint
According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. The information is provided for dermal route.
Justification for selection of acute toxicity – dermal endpoint
Only one study available.
Justification for classification or non-classification
Based on available data, the substance is not classified for acute toxicity according to CLP Regulation (EC) no 1272/2008.
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