Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 606-948-7 | CAS number: 2217-02-9
- 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 oral toxicity: Weight of evidence: Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of d-alpha fenchol is 6500 mg/kg bw in rats.
Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is >7859 mg/kg bw in rats.
Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is 7072 mg/kg bw in mice.
Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue fenchol, the acute oral LD50 value of d-alpha fenchol is 2050 mg/kg bw in rats.
Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rabbits.
Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of the test item was determined to be greater than 15717 mg/kg bw in rabbits.
Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue fenchol, The acute dermal LD50 value of the test item was >2000 mg/kg bw in guinea pigs.
Acute inhalation toxicity: Data waiving (study scientifically not necessary): 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 needs to be provided. The information is provided for dermal route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 2050, 2560, 3200, 4000 and 5000 mg/kg bw.
- No. of animals per sex per dose:
- 2 animals for doses of 2050, 2560 and 4000 mg/kg bw
3 animals for dose of 3200 mg/kg bw
5 animals for dose of 5000 mg/kg bw - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 050 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All deaths occurred between days 1 and 3.
At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. - Clinical signs:
- other: Clinical signs included lethargy, ataxia, tearing, comatose and flaccid (no further details were reported).
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute oral LD50 value of the test substance was found to be 2050 mg/kg bw in rats.
- Executive summary:
The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A scientific review (peer reviewed). No data on GLP.
- Principles of method if other than guideline:
- No data on the method.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute oral LD50 value of the test substance was >10000 mg/kg bw in rats.
- Executive summary:
According to the peer reviewed article, the acute oral LD50 value of the test substance was >10000 mg/kg bw in rats.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A scientific publication peer reviewed. No data on GLP.
- Principles of method if other than guideline:
- LC50 oral (gavage) determined in mouse.
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 9 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute oral LD50 value of the test substance in mice is 9000 mg/kg/bw.
- Executive summary:
According to the peer reviewed publication, the acute oral LD50 value of the test substance is 9000 mg/kg bw in mice.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A scientific review (peer reviewed). No data on GLP.
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 6 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: mean value of 5800-7200 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute oral LD50 value of the test substance is 6500 mg/kg bw in rats
- Executive summary:
According to the peer reviewed article, the acute oral LD50 value of the test substance is 6500 mg/kg bw in rats
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance fenchol which shares the same functional groups with the substance d-alpha fenchol also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 050 mg/kg bw
- Based on:
- other: Read across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 = 2050 mg/kg bw
- Mortality:
- All deaths occurred between days 1 and 3.
At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. - Clinical signs:
- other: Clinical signs included lethargy, ataxia, tearing, comatose and flaccid (no further details were reported).
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on the read-across approach from the analogue fenchol, the acute oral LD50 value of d-alpha fenchol is expected to be 2050 mg/kg bw in rats.
- Executive summary:
The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 mg/kg bw. Based on these results, the read-across approach was applied and the acute oral LD50 value of d-alpha fenchol was calculated to be 2050 mg/kg bw in rats.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which shares the same functional groups with the substance D-alpha fenchol and also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 7 859 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 > 10000 mg/kg bw.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is >7859 mg/kg bw in rats.
- Executive summary:
Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol was determined to be >7859 mg/kg bw in rats.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance L-Borneol which shares the same functional groups with the substance d-alpha fenchol also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 6 500 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LC50 = 6500 mg/L
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of d-alpha fenchol is 6500 mg/kg bw in rats.
- Executive summary:
Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of d-alpha fenchol is 6500 mg/kg bw in rats.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which shares the same functional groups with the substance D-alpha fenchol and also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 7 072 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 = 9000 mg/kg bw
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is 7072 mg/kg bw in mice.
- Executive summary:
Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol was determined to be 7072 mg/kg bw in mice.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 050 mg/kg bw
- Quality of whole database:
- Weight of evidence from several peer reviewed articles and secondary literature.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), 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 needs to be provided. The information is provided for dermal route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths ocurred.
- Clinical signs:
- other: Not specified
- Gross pathology:
- Not specified
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute dermal LD50 value of the test substance was >2000 mg/kg bw in guinea pigs.
- Executive summary:
The acute dermal toxicity of Fenchol was evaluated in 2 guinea pigs. Test substance was administered via dermal application at 2000 mg/kg/body weight. The animals were observed for 14 days. No deaths occurred. Thus, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A scientific review (peer reviewed). No data on GLP.
- Principles of method if other than guideline:
- No data provided on the method.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute dermal LD50 value of the test substance was >20000 mg/kg bw in rabbits.
- Executive summary:
According to the peer reviewed article, the acute dermal LD50 value of the test substance was >20000 mg/kg bw in rabbits.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A scientific review (peer reviewed). No data on GLP.
- Principles of method if other than guideline:
- No data on test method
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The acute dermal LD50 value of the test substance was >2000 mg/kg bw in rabbits.
- Executive summary:
According to the peer reviewed article, the acute dermal LD50 value of the test substance was >2000 mg/kg bw in rabbits.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance fenchol which shares the same functional groups with the substance d-alpha fenchol also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: Read across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 > 2000 mg/kg bw
- Mortality:
- No deaths ocurred.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on the read-across approach from the analogue fenchol, the acute dermal LD50 value of the d-alpha fenchol is expected to be >2000 mg/kg bw in guinea pigs.
- Executive summary:
The acute dermal toxicity of Fenchol was evaluated in 2 guinea pigs. Test substance was administered via dermal application at 2000 mg/kg/body weight. The animals were observed for 14 days. No deaths occurred. Thus, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw. Based on these results, the read across approach was applied and the acute dermal LD50 value of the d-alpha fenchol was calculated to be >2000 mg/kg bw in guinea pigs.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which shares the same functional groups with the substance D-alpha fenchol and also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 15 717 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 > 20000 mg/kg bw.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of the test item is >15717 mg/kg bw in rabbits.
- Executive summary:
Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of the test item was determined to be greater than 15717 mg/kg bw in rabbits.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance L-Borneol which shares the same functional groups with the substance D-alpha fenchol also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: Read-across from an analogue
- Remarks on result:
- other: read-across from an analogue for which LD50 > 2000 mg/kg bw.
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rabbits.
- Executive summary:
Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rabbits.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Weight of evidence from several peer reviewed articles and secondary literature.
Additional information
Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of d-alpha fenchol is 6500 mg/kg bw in rats.
Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is >7859 mg/kg bw in rats.
Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is 7072 mg/kg bw in mice.
Acute oral toxicity: Weight of evidence: The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 mg/kg bw. Based on these results, the read-across approach was applied and the acute oral LD50 value of d-alpha fenchol was calculated to be 2050 mg/kg bw in rats.
Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rabbits.
Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of the test item was determined to be greater than 15717 mg/kg bw in rabbits.
Acute dermal toxicity: Weight of evidence. The acute dermal toxicity of the test item was evaluated in 2 guinea pigs. Test substance was administered via dermal application at 2000 mg/kg/body weight. The animals were observed for 14 days. No deaths occurred. Thus, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw. Based on these results, the read across approach was applied and the acute dermal LD50 value of the d-alpha fenchol was calculated to be >2000 mg/kg bw in guinea pigs.
Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), 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 needs to be provided. The information is provided for dermal route.
Justification for classification or non-classification
Based on the available data, the substance is not classified for acute toxicity according to CLP Regulation (EC) no. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
