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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-717-3 | CAS number: -
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15 March - 19 April 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no data about purity and no certificate of analysis of the test substance; no data on bodyweight changes
- Justification for type of information:
- Sclareol is one of the main constituent of Clary sage concrete (it represents between 40 and 80% of the substance).
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Sclareol is one of the main constituent of Clary sage concrete (it represents between 40 and 80% of the substance).
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 of the test substance is >5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.
- Executive summary:
In an acute oral toxicity study performed similarly to OECD Guideline 401, a single oral (gavage) dose of 5000 mg/kg bw of the test substance, in 25% gravimetric suspension in corn oil, was given to 5 male
and 5 female Wistar rats. Animals were then observed for mortality and clinical signs of toxicity for 14 days; and all were macroscopically necropsied after sacrifice.
No deaths occurred. Clinical signs including slight depression, and moist and matter hair were noted in all animals within 3 -24 hours after treatment, but all appeared normal after 5 days. Internal organs
on superficial examination appeared normal except for a deposit of fibrous tissue in the thoracic cavity in one animal.
Rat Oral LD50 > 5000 mg/kg bw.
Under the test conditions, the oral LD50 of the test substance is >5000 mg/kg bw.
Therefore Clary sage concrete is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no data about purity and no certificate of analysis of the test substance; no data on bodyweight changes
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- [1R-[1α(R*),2β,4aβ,8aα]]-2-hydroxy-α,2,5,5,8a-pentamethyl-α-vinyldecahydronaphthalene-1-propan-1-ol
- EC Number:
- 208-194-0
- EC Name:
- [1R-[1α(R*),2β,4aβ,8aα]]-2-hydroxy-α,2,5,5,8a-pentamethyl-α-vinyldecahydronaphthalene-1-propan-1-ol
- Cas Number:
- 515-03-7
- Molecular formula:
- C20H36O2
- IUPAC Name:
- (1R,2R,4aS,8aS)-1-[(3R)-3-hydroxy-3-methylpent-4-enyl]-2,5,5,8a-tetramethyl-3,4,4a,6,7,8-hexahydro-1H-naphthalen-2-ol
- Test material form:
- other: the substance is considered as liquid
- Details on test material:
- - Name of test material (as cited in study report): sclareol
- Substance type: monoconstituent
- Physical state: liquid
- Analytical purity: see confidential details
- Impurities (identity and concentrations): see confidential details
- Composition of test material, percentage of components: see confidential details
- Isomers composition: see confidential details
- Purity test date: see confidential details
- Lot/batch No.: see confidential details
- Expiration date of the lot/batch: see confidential details
- Stability under test conditions: not applicable
- Storage condition of test material: not applicable
Constituent 1
- Specific details on test material used for the study:
- Batch: W1626
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Licensed dealer
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 200-250 g
- Fasting period before study: ca. 18 hours
- Housing: Housed in galvanized cages with indirect bedding, in a temperature controlled room
- Diet: Growth and maintenance ration from a commercial producer, ad libitum
- Water: Ad libitum
- Acclimation period: At least 2 days
ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 hours dark / 12 hours light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- DOSAGE PREPARATION: Test item was used in 25% gravimetric suspension in corn oil.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6 and 24 hours post-dosage, and at least once daily thereafter for a total of 14 days.
- Necropsy: Non-survivors and animals surviving the 14 day observation period were subjected to gross necropsy, with all findings noted. - Statistics:
- No data
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- Clinical signs including slight depression, and moist and matter hair were noted in all animals within 3 -24 hours after treatment, but all appeared normal after 5 days.
- Body weight:
- No data
- Gross pathology:
- Internal organs on superficial examination appeared normal except for a deposit of fibrous tissue in the thoracic cavity in one animal.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 of the test substance is >5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.
- Executive summary:
In an acute oral toxicity study performed similarly to OECD Guideline 401, a single oral (gavage) dose of 5000 mg/kg bw of the test substance, in 25% gravimetric suspension in corn oil, was given to 5 male and 5 female Wistar rats. Animals were then observed for mortality and clinical signs of toxicity for 14 days; and all were macroscopically necropsied after sacrifice.
No deaths occurred. Clinical signs including slight depression, and moist and matter hair were noted in all animals within 3 -24 hours after treatment, but all appeared normal after 5 days. Internal organs on superficial examination appeared normal except for a deposit of fibrous tissue in the thoracic cavity in one animal.
Rat Oral LD50 > 5000 mg/kg bw.
Under the test conditions, the oral LD50 of the test substance is >5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS.
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.