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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
Endpoint summary
Administrative data
Description of key information
Based on a Read across strategy, the substance is considered to have a DL50 higher than 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Rats were treated with test substance by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Specific details on test material used for the study:
- No data
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: Ca. 18 h prior to treatment
- Diet: Food, ad libitum
- Water, ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 2 weeks
Frequency of observations and weighing: Frequency not known, all animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal or showed weight gain - Statistics:
- LD50 with 95 % confidence limits was calculated with use of Litchfield-Wilcoxon's method (1949).
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 790 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 440 - < 3 180
- Mortality:
- Mortality was observed between 4 and 18 h after test substance administration.
- Clinical signs:
- Ataxia soon after treatment was observed.
- Body weight:
- No data
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute oral toxicity study, Osborne-Mendel rats were treated with Linalool by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).
Mortality was observed between 4 and 18 h after test substance administration. Ataxia soon after treatment was observed. In this study, the oral LD50 of test substance was 2790 mg/kg bw (95 % Cl: 2440-3180) in rats.
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only short abstract available
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- Rats were treated with test substance by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Specific details on test material used for the study:
- No data
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: Ca. 18 h prior to treatment
- Diet: Food, ad libitum
- Water, ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 2 weeks
- Statistics:
- LD50 with 95 % confidence limits was calculated with use of Litchfield-Wilcoxon's method (1949).
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 14 550 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 12 300 - < 17 170
- Mortality:
- Mortality was observed between 4 h and 4 days after test substance administration.
- Clinical signs:
- Depression soon after treatment, coma and wet posterior region were observed.
- Body weight:
- No data
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute oral toxicity study, Osborne-Mendel rats were treated with Linalyl acetate by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).
Mortality was observed between 4 h and 4 days after test substance administration. Depression soon after treatment, coma and wet posterior region were observed. In this study, the oral LD50 of test substance was 14550 mg/kg bw (95 % Cl: 12300-17170) in rats.
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- 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).
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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
- Specific details on test material used for the study:
- Batch: W1626
- 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 - 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
- Preliminary study:
- Not applicable
- 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
- 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.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Linalool is one of the main constituents of Clary sage concrete , it represents up to 10% of the composition
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Rats were treated with test substance by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 790 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 440 - < 3 180
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute oral toxicity study, Osborne-Mendel rats were treated with Linalool by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).
Mortality was observed between 4 and 18 h after test substance administration. Ataxia soon after treatment was observed. In this study, the oral LD50 of test substance was 2790 mg/kg bw (95 % Cl: 2440-3180) in rats.
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Therefore the registered substance is considered to have a DL 50 higher than 2790 mg/kg bw
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Linalyl acetate is one of the main constituent of Clary sage concrete (it represents up to 20 % of the substance).
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Rats were treated with test substance by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 14 550 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 12 300 - < 17 170
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute oral toxicity study, Osborne-Mendel rats were treated with Linalyl acetate by oral gavage and then observed for clinical signs and mortality for two weeks. LD50 was computed by the method of Litchfield & Wilcoxon (1949).
Mortality was observed between 4 h and 4 days after test substance administration. Depression soon after treatment, coma and wet posterior region were observed. In this study, the oral LD50 of test substance was 14550 mg/kg bw (95 % Cl: 12300-17170) in rats.
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Therefore the registered substance is considered to have a LD50 higher than 14 550 mg/kg bw.
- 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
Referenceopen allclose all
None
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Sclareol is one of the main constituent of Clary sage concrete (it represents between 40 and 80% of the substance), and has a DL50 higher than 5000 mg/kg bw in rats. Linalyl acetate represents up to 20% of the substance and has a DL50 higher than 14 550 mg/kg bw. Linalool, represents up to 10% of the substance and has a DL 50 higher than 2790 mg/kg bw. Therefore the DL50 of the registered substance is considered to be higher than 2000 mg/kg bw.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity via Oral route:
Based on the available data the substance is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the Globally Harmonised System of classification and labelling of chemicals (GHS) as the oral LD50 is higher than 2000 mg/kg bw.
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.