Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 207-353-1 | CAS number: 464-45-9
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- - Principle of test: Study of metabolism of Borneol by the analysis of incubations of in vitro-prepared rat liver microsomes
- Short description of test conditions: see description below
- Parameters analysed / observed: Metabolites of Borneol in rat liver microsomes. - GLP compliance:
- not specified
- Radiolabelling:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Animal Center of Guangdong Province, P.R. China
- Age at study initiation: ca. 50 days
- Weight at study initiation: 230–250 g
- Housing: steel cages
- Diet (e.g. ad libitum): control diet
- Water (e.g. ad libitum): control diet
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22–26°C
- Humidity (%): 50–60% - Route of administration:
- other: In vitro incubation with rat liver microsomes
- Details on exposure:
- A typical incubation mixture consisted of 2.5 mg/mL rat liver microsmal protein, 0.1M potassium phosphate buffer (pH 7.4), 1mM Nicotinamide-adenine dinucleotide phosphate (NADPH), and 325μM Borneol with a final volume of 1 mL. Borneol was dissolved in methanol (final concentration in the reaction medium of < 1.0%).
The reaction was initiated by the addition of the NADPH, and then the oxygen was quickly added with a syringe needle going into the middle of the mixtures for 40 s.
Control incubations were performed using inactivated microsomes, which were boiled in 90°C water for 45 min.
After incubation in a shaking water bath at 37°C for 30 min, the reaction was terminated by adding 2 mL ethyl acetate. The mixture was extracted for 10 min by shaking vigorously and then centrifuged at 15,000 × g for 10 min.
The organic phases were directly injected into the Gas chromatography (GC)–Mass spectrometry (MS) for analysis. - Details on dosing and sampling:
- METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: rat liver microsomes
- Method type(s) for identification: GC-MS - Type:
- metabolism
- Results:
- Four metabolites (M1, M2, M3, and M4) were observed in the incubation mixture, which were not present in the control incubations
- Metabolites identified:
- yes
- Details on metabolites:
- Borneol was rapidly metabolized to four metabolites:
M1 (m/z 152): molecular weight of two mass units less than Borneol. M1 was confirmed as camphor by comparison with the standard mass spectrum library (NIST library, 95% similarity).
M2 (m/z 122): molecular weight of 32 mass units less than Borneol. It was proposed that this is the de-methylated and de-hydrated metabolite of Borneol. Although, further investigation is required to positively identify this metabolite.
M3 (m/z 170) and M4 (m/z 170): molecular weight of 16 mass units more than Borneol. it was proposed that M3 and M4 are probably hydroxylated metabolite(s) of borneol, although these will require further study to be certain. - Conclusions:
- Borneol was rapidly metabolized to four phase I metabolites in incubations with normal rat liver microsomes in the presence of NADPH.
- Executive summary:
The metabolism of borneol was studied by the analysis of incubations of in vitro-prepared rat liver microsomes. Male Sprague-Dawley rats, aged approximately 50 days and weighing 230–250 g, were used for the study. A typical incubation mixture was performed in a shaking water bath at 37°C for 30 min and consisted of 2.5 mg/mL rat liver microsmal protein, 0.1M potassium phosphate buffer (pH 7.4), 1mM NADPH, and 325μM Bornel with a final volume of 1 mL. Gas chromatography (GC)–mass spectrometry (MS) method was developed for the identification of Borneol and its metabolites. Four phase I metabolites were detected: M1 (m/z 152) confirmed as camphor, M2 (m/z 122) proposed as the de-methylated and de-hydrated metabolite, M3 (m/z 170) and M4 (m/z 170) both proposed as the hydroxylated metabolites.
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- 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 DL-Borneol which shares the same functional groups with the substance L-Borneol also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Metabolites identified:
- yes
- Details on metabolites:
- Results based on read-across from analogue Borneol.
Borneol was rapidly metabolized to four metabolites:
M1 (m/z 152): molecular weight of two mass units less than Borneol. M1 was confirmed as camphor by comparison with the standard mass spectrum library (NIST library, 95% similarity).
M2 (m/z 122): molecular weight of 32 mass units less than Borneol. It was proposed that this is the de-methylated and de-hydrated metabolite of Borneol. Although, further investigation is required to positively identify this metabolite.
M3 (m/z 170) and M4 (m/z 170): molecular weight of 16 mass units more than Borneol. it was proposed that M3 and M4 are probably hydroxylated metabolite(s) of borneol, although these will require further study to be certain. - Conclusions:
- Based on the read-across approach from the analogue DL-Borneol, L-Borneol was determined to be rapidly metabolized to four phase I metabolites in incubations with normal rat liver microsomes in the presence of NADPH.
- Executive summary:
The metabolism of borneol was studied by the analysis of incubations of in vitro-prepared rat liver microsomes. Male Sprague-Dawley rats, aged approximately 50 days and weighing 230–250 g, were used for the study. A typical incubation mixture was performed in a shaking water bath at 37°C for 30 min and consisted of 2.5 mg/mL rat liver microsmal protein, 0.1M potassium phosphate buffer (pH 7.4), 1mM NADPH, and 325μM Bornel with a final volume of 1 mL. Gas chromatography (GC)–mass spectrometry (MS) method was developed for the identification of Borneol and its metabolites. The read-across was applied and based on results of this study, L-Borneol was determined to have four phase I metabolites: M1 (m/z 152) confirmed as camphor, M2 (m/z 122) proposed as the de-methylated and de-hydrated metabolite, M3 (m/z 170) and M4 (m/z 170) both proposed as the hydroxylated metabolites.
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- other: Obtaining of glycuronic acid through the feeding of borneol to dogs
- Principles of method if other than guideline:
- - Principle of test: preparation of glycuronic acid obtained through the excretion of borneol glycuronic acid after feeding dogs with borneol
- Short description of test conditions: see description below
- Parameters analysed / observed: Excretion of borneol glycuronic acid in urine - GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- dog
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data.
- Route of administration:
- oral: feed
- Vehicle:
- other: unchanged or suspended in gelatin glucose mixture
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Borneol was incorporated directly with the food or suspended in a small volume of gelatin glucose mixture.
- Duration and frequency of treatment / exposure:
- Frequency of treatment: Daily
- Dose / conc.:
- 5 other: g/day
- Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): urine
- Time and frequency of sampling: daily - Type:
- excretion
- Results:
- Approximately 50% of the daily dose of 5 g borneol was excreted in the urine as borneol glycuronic acid.
- Metabolites identified:
- no
- Conclusions:
- Approximately 50% of the daily dose of 5 g borneol in dogs was excreted in the urine as borneol glycuronic acid.
- Executive summary:
Borneol at dose level of 5.0 g was incorporated directly with the food or suspended in a small volume of gelatin glucose mixture and fed daily to dogs. Approximately 50% of the daily dose of 5 g borneol was excreted in the urine as borneol glycuronic acid.
- Endpoint:
- basic toxicokinetics in vivo
- 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 DL-Borneol which shares the same functional groups with the substance L-Borneol also has comparable values for the relevant molecular properties.
See attached the reporting format. - Reason / purpose for cross-reference:
- read-across source
- Type:
- excretion
- Results:
- Based on results from analogue borneol, about 50% of a daily dose of L-borneol to dogs is expected to be excreted in the urine as the glycuronic acid conjugate.
- Metabolites identified:
- no
- Conclusions:
- Based on the read-across approach from the analogue DL-borneol, about 50% of a daily dose of L-borneol to dogs is expected to be excreted in the urine as the glycuronic acid conjugate.
- Executive summary:
Borneol at dose level of 5.0 g was incorporated directly with the food or suspended in a small volume of gelatin glucose mixture and fed daily to dogs. Approximately 50% of the daily dose of 5 g borneol was excreted in the urine as borneol glycuronic acid. The read-across was applied and based on results of this study, about 50% of a daily dose of L-borneol to dogs is expected to be excreted in the urine as the glycuronic acid conjugate.
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- - Principle of test: Study on the glucuronidation of various chemicals by human embryonic kidney 293 cells expressing UDP-glucuronosyltransferase 1.4 protein.
- Short description of test conditions: see description below
- Parameters analysed / observed: rate of glucuronidation. - GLP compliance:
- not specified
- Radiolabelling:
- no
- Species:
- other: Human
- Details on test animals or test system and environmental conditions:
- embryonic kidney 293 cells (whole-cell homogenates) expressing UDP-glucuronosyltransferase 1.4 protein were used.
- Route of administration:
- other: In vitro incubation with embryonic kidney 293 cells
- Details on exposure:
- The assays were performed at 37ºC embryonic kidney 293 cells (whole-cell homogenates) expressing UDP-glucuronosyltransferase 1.4 protein.
The incubation time was 0.5-2 h. - Dose / conc.:
- 0.5 other: mM
- Remarks:
- Concentration of L-Borneol on incubation mixture
- Details on dosing and sampling:
- METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: Human embryonic kidney 293 cells - Type:
- metabolism
- Results:
- The rate of glucuronidation of 0.5 mM l-borneol by human embryonic kidney 293 cells expressing UDP-glucuronosyltransferase 1.4 protein was 29 pmol/min/mg protein
- Metabolites identified:
- no
- Conclusions:
- The rate of glucuronidation of 0.5 mM L-borneol by human embryonic kidney 293 cells expressing UDP-glucuronosyltransferase 1.4 protein was 29 pmol/min/mg protein.
- Executive summary:
The glucuronidation of L-Borneol by human embryonic kidney 293 cells expressing UDP-glucuronosyltransferase 1.4 protein was investigated. The assays were performed at 37ºC with a concentration of L-Borneol of 0.5 mM and an incubation time of 0.5-2 h. The rate of glucuronidation of L-Borneol was found to be 29 pmol/min/mg protein.
Referenceopen allclose all
Description of key information
Weight of Evidence: Read-across approach. Based on the read-across approach from the analogue DL-Borneol, L-Borneol was determined to be rapidly metabolized to four phase I metabolites in incubations with normal rat liver microsomes in the presence of NADPH.
Weight of Evidence: Read-across approach. Based on the read-across approach from the analogue DL-Borneol, about 50% of a daily dose of L-Borneol to dogs is expected to be excreted in the urine as the glycuronic acid conjugate.
Weight of Evidence: In vitro human study on L-Borneol. The rate of glucuronidation of 0.5 mM L-borneol by human embryonic kidney 293 cells expressing UDP-glucuronosyltransferase 1.4 protein was 29 pmol/min/mg protein.
Key value for chemical safety assessment
Additional information
Weight of evidence. Read-across approach from experimental data on the analogue substance DL-Borneol: The metabolism of borneol was studied by the analysis of incubations of in vitro-prepared rat liver microsomes. Male Sprague-Dawley rats, aged approximately 50 days and weighing 230–250 g, were used for the study. A typical incubation mixture was performed in a shaking water bath at 37°C for 30 min and consisted of 2.5 mg/mL rat liver microsmal protein, 0.1M potassium phosphate buffer (pH 7.4), 1mM NADPH, and 325μM Bornel with a final volume of 1 mL. Gas chromatography (GC)–mass spectrometry (MS) method was developed for the identification of Borneol and its metabolites. The read-across was applied and based on results of this study, L-Borneol was determined to have four phase I metabolites: M1 (m/z 152) confirmed as camphor, M2 (m/z 122) proposed as the de-methylated and de-hydrated metabolite, M3 (m/z 170) and M4 (m/z 170) both proposed as the hydroxylated metabolites.
Weight of Evidence: Read-across approach from experimental data on the analogue substance DL-Borneol: Borneol at dose level of 5.0 g was incorporated directly with the food or suspended in a small volume of gelatin glucose mixture and fed daily to dogs. Approximately 50% of the daily dose of 5 g borneol was excreted in the urine as borneol glycuronic acid. The read-across was applied and based on results of this study, about 50% of a daily dose of L-borneol to dogs is expected to be excreted in the urine as the glycuronic acid conjugate.
Weight of Evidence: In vitro human study on L-Borneol. The glucuronidation of L-Borneol by human embryonic kidney 293 cells expressing UDP-glucuronosyltransferase 1.4 protein was investigated. The assays were performed at 37ºC with a concentration of L-Borneol of 0.5 mM and an incubation time of 0.5-2 h. The rate of glucuronidation of L-Borneol was found to be 29 pmol/min/mg protein.
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.