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EC number: 283-911-8 | CAS number: 84775-83-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Salvia sclarea, Labiatae.
- 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
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1996
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD Guideline 301 C but with deviations: no detail on material and methods
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- Deviations:
- yes
- Remarks:
- no detail on material and methods
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
No data - Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Concentration of sludge: 30 mg/L
- Duration of test (contact time):
- 28 d
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
- Details on study design:
- No data
- Preliminary study:
- No data
- Test performance:
- No data
- Parameter:
- % degradation (O2 consumption)
- Value:
- >= 90 - <= 99
- Sampling time:
- 28 d
- Details on results:
- - Indirect analysis (BOD): 90%
- Direct analysis (TOC) & (GC): 99% and 100% respectively. - Results with reference substance:
- No data
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Under the test conditions, linalool was readily biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, linalool was tested at concentrations of 100 mg/L and the inoculum was activated sludge (30 mg/L). The degradation of the test material was assessed by the determination of the oxygen consumption.
At 100 mg/L test concentration, 90 -99% degradation (biochemical oxygen demand) was reached in 28 days.
Under the test conditions, linalool was readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- - Only limited information is available on the test. No information about the composition of the medium, pH during the test, light regime and shaking during the study. All of these are important factors in the degradation of the test substance. - In a curve showing the oxygen consumption over 28 days, beside a sludge control (30 mg/L) also a blank control (100 mg/L) is included. This is probably due to a mistake, because in the report no information is given about an abiotic control included in this study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- Deviations:
- yes
- Remarks:
- limited information on material and methods
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Specific details on test material used for the study:
- No data
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Concentration of sludge: 30 mg/L
- prepared from soil of river bank, sludge of a municipal treatment plant and sludge of an industrial sewage plant. - Duration of test (contact time):
- 28 d
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- - 2 flasks Treated (basal culture medium + activated sludge + linalyl acetate (100-102 mg/L));
- 1 flask Positive Control (basal culture medium + activated sludge + Aniline (92 mg/L));
- 1 flask Blank Control (basal culture medium + activated sludge).
Incubation was performed for 28 days at 20°C. - Preliminary study:
- No data
- Test performance:
- No data
- Parameter:
- % degradation (O2 consumption)
- Value:
- 75
- Sampling time:
- 28 d
- Details on results:
- See next section "any other information on results incl. tables"
- Results with reference substance:
- See next section "any other information on results incl. tables"
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Under the test conditions, linalyl acetate was readily biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, linalyl acetate (purity 96.0%) was tested and the inoculum was activated sludge (30 mg/L). The test was performed as follow:
- 2 flasks Treated (basal culture medium + activated sludge + linalyl acetate (100-102 mg/L));
- 1 flask Positive Control (basal culture medium + activated sludge + Aniline (92 mg/L));
- 1 flask Blank Control (basal culture medium + activated sludge).
The degradation of the test material was assessed by the determination of the oxygen consumption.
The incubation was performed for 28 days at 20°C. The oxygen consumption was determined daily with a volumetric respirometer.
The results of the biodegradation values for linalyl acetate and positive control are shown in the table herafter:
Treatment Mean % biodegradation [% of ThOD] on day: 1 4 7 10 14 18 22 28 Linalyl acetate 4 33 54 62 68 71 73 75 Positive control 0 9.4 72 74 77 78 80 84 The mean % biodegradation of linalyl acetate reached 75% on day 28 and the 10-day window criterion was successful.
Therefore, under the test conditions, the substance linalyl acetate was considered as readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD Guideline 301 C but with deviations: no detail on material and methods
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- Deviations:
- yes
- Remarks:
- no detail on material and methods
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- No data
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Concentration of sludge: 30 ppm
- Duration of test (contact time):
- 2 wk
- Initial conc.:
- 100 other: ppm
- Based on:
- test mat.
- Details on study design:
- No data
- Preliminary study:
- No data
- Test performance:
- No data
- Parameter:
- % degradation (O2 consumption)
- Value:
- 84.6
- Sampling time:
- 2 wk
- Details on results:
- - Indirect analysis (BOD): 84.6%
- Direct analysis (GC): 100%
- Direct analysis (TOC): 93% - Results with reference substance:
- No data
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Under the test conditions, alpha-terpineol was readily biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, alpha-terpineol was tested at concentrations of 100 ppm and the inoculum was activated sludge (30 ppm). The degradation of the test material was assessed by the determination of the oxygen consumption.
At 100 ppm test concentration, 84.6% degradation by biochemical oxygen demand was reached in 2 weeks.
Under the test conditions, alpha-terpineol was readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1987
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD Guideline 301 C but with deviations: no detail on material and methods
- Justification for type of information:
- Read-across based on results from MITI data on beta-myrcene extrapolated to beta-ocimene.
Indeed, beta-myrcene and beta-ocimene have similar SMILES and the same Molecular Weight (136.24 g/mol) as well as the same formula (C10 H16). In addition, their chemical class is neutral organics for the both substances according to EPISuite ECOSAR v1.11. Furthermore, their log Kow and solubility have been estimated with EPISuite Kowwin v1.68 and EPISuite WSKowwin v 1.43 respectively. The log Kow and Water Solubility Estimates were in the same order (Log Kow = 4.17; WS = 9.02 mg/L and Log Kow = 4.80; WS = 2.01 mg/L for beta-myrcene and for beta-ocimene respectively. Based on all this information, it can be assumed that having similar properties and mode of action, similar environmental behaviour is expected. That is why ready biodegradation results from beta-myrcene is here extrapolated to beta-ocimene. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- Deviations:
- yes
- Remarks:
- no detail on material and methods
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- No data
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Concentration of sludge: 30 ppm
- Duration of test (contact time):
- 2 wk
- Initial conc.:
- 100 other: ppm
- Based on:
- test mat.
- Details on study design:
- No data
- Preliminary study:
- No data
- Test performance:
- No data
- Parameter:
- % degradation (O2 consumption)
- Value:
- 86
- Sampling time:
- 2 wk
- Details on results:
- - Indirect analysis (BOD): 86%
- Direct analysis (GC): 99%
- Direct analysis (TOC): 87% - Results with reference substance:
- No data
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Under the test conditions, myrcene beta was readily biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, myrcene-beta was tested at concentrations of 100 ppm and the inoculum was activated sludge (30 ppm). The degradation of the test material was assessed by the determination of the oxygen consumption.
At 100 ppm test concentration, 86% degradation by biochemical oxygen demand was reached in 2 weeks.
Under the test conditions, myrcene beta was readily biodegradable.
- Endpoint:
- biodegradation in water: screening tests
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2017-08-04 to 2017-08-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Remarks:
- The value is not an experimental result, however the QSAR model is recommended by the ECHA guidance document on information requirements, is well documented with regard to validation parameters according to OECD principles. Moreover, the substance is fully characterised towards the applicability domain.
- Justification for type of information:
- QSAR prediction
- Qualifier:
- according to guideline
- Guideline:
- other: Reach Guidance on QSAR - R.6
- Deviations:
- no
- Principles of method if other than guideline:
- QSAR, Biowin v4.10. More details are given in QMRF/QPRF attached to the dossier.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - SMILES: C(=CCCC(C(C(C1(C)C)C2)C1)=C)(C2)C
- CHEM: Bicyclo 7.2.0 undec-4-ene, 4,11,11-trimethyl-8-methylene-, 1R-(1R*,4E,9S*) -
- MOL FOR: C15 H24
- MOL WT: 204.36 - Oxygen conditions:
- not specified
- Inoculum or test system:
- not specified
- Details on inoculum:
- not applicable
- Details on study design:
- not applicable
- Preliminary study:
- not applicable
- Test performance:
- not applicable
- Parameter:
- probability of ready biodegradability (QSAR/QSPR)
- Remarks on result:
- not readily biodegradable based on QSAR/QSPR prediction
- Details on results:
- Biowin 1 (linear model prediction) = Does not Biodegrade Fast
Biowin 2 (non-linear model prediction) = Does not Biodegrade Fast
Biowin 3 (ultimate biodegradation timeframe) = Weeks-Months
Biowin 4 (Primary biodegradation timeframe) = Days-Weeks
Biowin 5 (MITI linear model prediction) = Not Readily Degradable
Biowin 6 (MITI non-linear model prediction) = Not Readily Degradable
Biowin 7 (Anaerobic model prediction) = Does not Biodegrade Fast
Ready Biodegradability Prediction: NO - Results with reference substance:
- not applicable
- Validity criteria fulfilled:
- not applicable
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- It is expected that the substance is not readily biodegradable.
- Executive summary:
The ready biodegradation property of the substance was investigated using QSAR approach with Biowin v4.10 plug-in from EPISUITE v4.1 from US EPA.
It's expected that the test item is not readily biodegradable.
- Endpoint:
- biodegradation in water: screening tests
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2017-08-04 to 2017-08-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Remarks:
- The value is not an experimental result, however the QSAR model is recommended by the ECHA guidance document on information requirements, is well documented with regard to validation parameters according to OECD principles. Moreover, the substance is fully characterised towards the applicability domain.
- Justification for type of information:
- QSAR prediction
- Qualifier:
- according to guideline
- Guideline:
- other: Reach Guidance on QSAR - R.6
- Deviations:
- no
- Principles of method if other than guideline:
- QSAR, Biowin v4.10. More details are given in QMRF/QPRF attached to the dossier.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - SMILES: CC1=CCCC(=C)C2CC(C2CC1)(C)C
- CHEM: (1Z,6Z)-1-methyl-5-methylidene-8-propan-2-ylcyclodeca-1,6-diene
- MOL FOR: C15 H24
- MOL WT: 204.35 - Oxygen conditions:
- not specified
- Inoculum or test system:
- not specified
- Details on inoculum:
- not applicable
- Details on study design:
- not applicable
- Preliminary study:
- not applicable
- Test performance:
- not applicable
- Parameter:
- probability of ready biodegradability (QSAR/QSPR)
- Remarks on result:
- not readily biodegradable based on QSAR/QSPR prediction
- Details on results:
- Biowin 1 (linear model prediction) = Does not Biodegrade Fast
Biowin 2 (non-linear model prediction) = Does not Biodegrade Fast
Biowin 3 (ultimate biodegradation timeframe) = Weeks-Months
Biowin 4 (Primary biodegradation timeframe) = Days-Weeks
Biowin 5 (MITI linear model prediction) = Not Readily Degradable
Biowin 6 (MITI non-linear model prediction) = Not Readily Degradable
Biowin 7 (Anaerobic model prediction) = Does not Biodegrade Fast
Ready Biodegradability Prediction: NO - Results with reference substance:
- not applicable
- Validity criteria fulfilled:
- not applicable
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- It is expected that the substance is not readily biodegradable.
- Executive summary:
The ready biodegradation property of the substance was investigated using QSAR approach with Biowin v4.10 plug-in from EPISUITE v4.1 from US EPA.
It's expected that the test item is not readily biodegradable.
Referenceopen allclose all
None
Biodegradation values for linalyl acetate and positive control. Values are corrected for blank control values:
Treatment | Mean % biodegradation [% of ThOD] on day: | |||||||
1 | 4 | 7 | 10 | 14 | 18 | 22 | 28 | |
Linalyl acetate | 4 | 33 | 54 | 62 | 68 | 71 | 73 | 75 |
Positive control | 0 | 9.4 | 72 | 74 | 77 | 78 | 80 | 84 |
None
None
Please see the attached documents.
Please see the attached documents.
Description of key information
Based on a Weight of Evidence approach with individual data on constituents, it can be possible to consider that Clary sage oil is readily biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
Based on typical composition, constituents above 1% represent 90.9% of the whole substance.
Amongst these constituents, most of them are considered as readily biodegradable (see table below):
Constituents |
CAS No |
Typical %* |
Biodegradation results |
Reference in IUCLID 6 |
Linalool |
78-70-6 |
11.35 |
Readily biodegradable |
Linalool, 78-70-6, Biodegradation in water: screening tests, MITI, 1996, RS, W |
Linalyl acetate |
115-95-7 |
67.87 |
Readily biodegradable |
Linalyl acetate, 115-95-7, Biodegradation in water: screening tests, OECD SIDS, 1991, RS, W |
alpha-terpineol | 98 -55 -5 | 3.08 | Readily biodegradable | alpha-terpineol, 98-55-5, Biodegradation in water: screening tests, MITI, 1978, RS, W |
beta-ocimene | 13877 -91 -3 | 1.00 | Readily biodegradable | beta-ocimene, 13877-91-3, Biodegradation in water: screening tests, MITI, 1987, RS, W |
Germacrene D | 37839 -63 -7 | 5.92 | Not readily biodegradable | Germacrene D, 37839-63-7, Biodegradation in water: screening tests, QSAR Biowinv4.10, RS, W |
Beta-caryophyllene | 87 -44 -5 | 1.68 |
Not readily biodegradable | Beta-caryophyllene, 87-44-5, Biodegradation in water: screening tests, QSAR Biowinv4.10, RS, W |
* Composition is based on typical %, taking into account constituents above 1%.
In total, 83.3% of the whole substance is composed by readily biodegradable constituents.
Based on a Weight of Evidence approach, it can therefore be possible to consider that the registered substance Clary sage oil is readily biodegradable.
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.