Registration Dossier
Registration Dossier
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EC number: 284-290-6 | CAS number: 84837-04-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lavandula latifolia, Labiatae.
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:
- 1994
- 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 details 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 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:
- 94
- Sampling time:
- 28 d
- Details on results:
- - Indirect analysis (BOD): 94%
- Direct analysis (GC): 100% - Results with reference substance:
- No data
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Under the test conditions, the chemical substance was determined to be ready biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, (D,L)-camphor 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, 94% degradation (biochemical oxygen demand) was reached in 28 days.
Under the test conditions, the substance was determined to be ready biodegradable.
- 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:
- 2007
- 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 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 - <= 95
- Sampling time:
- 28 d
- Details on results:
- - Indirect analysis (BOD): 91, 90 and 95%
- Direct analysis (GC): 100, 100 and 100% - Results with reference substance:
- No data
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Under the test conditions, alpha-pinene was readily biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, alpha-pinene 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 -95% degradation (biochemical oxygen demand) was reached in 28 days.
Under the test conditions, alpha-pinene was readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1988
- 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 mg/L
- Duration of test (contact time):
- 4 wk
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
- Details on study design:
- Improved type for a volatile substance
- Preliminary study:
- No data
- Test performance:
- No data
- Parameter:
- % degradation (O2 consumption)
- Value:
- >= 2 - <= 16
- Sampling time:
- 4 wk
- Details on results:
- - Indirect analysis (BOD): 2%
- Direct analysis (GC): 16% - Results with reference substance:
- No data
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- Under the test conditions, camphene was not found to be readily biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, camphene 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, 2 - 16 % degradation was reached in 28 days.
Under the test conditions, camphene was not found to be readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1980
- 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):
- 14 d
- 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:
- >= 41 - <= 98
- Sampling time:
- 14 d
- Details on results:
- - Indirect analysis (BOD): 41, 81 and 98%
- Direct analysis (GC): 100%
- Direct analysis (TOC): 50, 73 and 81% - Results with reference substance:
- No data
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Under the test conditions, Limonene was readily biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, Limonene 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, 41-98% degradation by biochemical oxygen demand was reached in 14 days.
Under the test conditions, Limonene 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
- 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: 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: 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: 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
- 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 mg/L
- Duration of test (contact time):
- 4 wk
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
- Details on study design:
- Improved type for a volatile substance
- Preliminary study:
- No data
- Test performance:
- No data
- Parameter:
- % degradation (O2 consumption)
- Value:
- 97
- Sampling time:
- 4 wk
- Details on results:
- - Indirect analysis (BOD): 97%
- Direct analysis (TOC and GC): 90% and 100% respectively - Results with reference substance:
- No data
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- Under the test conditions, the test item was found to be readily biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, the substance 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, 97% degradation (BOD) was reached in 4 weeks.
Under the test conditions, the test item was found to be 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=CCC(CC1)C(=CCC=C(C)C)C
- 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) = Biodegrades Fast
Biowin 2 (non-linear model prediction) = Biodegrades 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: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 1997.09.25 to 1997.11.11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study was performed according to OECD Guideline 301F with GLP statement. All validity criteria were fulfilled and no deviations were observed.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- None
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- Fresh activated sludge from a biological waste water treatment plant treating predominantly domestic sewage (City of Geneva, Aïre) was used. The sludge is collected in the morning, washed three times in the mineral medium (by centrifuging at 1000 g for 10 minutes, discarding the supernatant and resuspending in mineral medium) and kept aerobic until being used on the same day.
Dry weight of suspended solids: 2.342 g/L.
To obtain a concentration of 30 mg/L (dry weight) in a 250 mL flask, 3.20 mL of sludge is needed (inoculum). - Duration of test (contact time):
- 38 d
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: The mineral medium was prepared by mixing 50 mL of solution A (8.5g of KH2PO4 + 21.75g of K2HPO4 + 33.4g of Na2HPO4.2H2O + 0.5g of NH4Cl, dissolved in water and made up to 1L) and 2L deionised water, adding 5 mL of each of the solutions B (27.5g of CaCl2, dissolved in water and made up to 1L), C (22.5g of MgSO4.7H2O, dissolved in water and made up to 1L) and D (0.25g of FeCl3.6H2O + one drop of HCl Conc., dissolved in water and made up to 1L) and making up to 5L with deionised water.
- Solubilising agent (type and concentration if used): not applicable
- Test temperature: 22°C
- pH adjusted: the pH of the mineral medium is measured and if necessary adjusted to 7.4 +/- 0.2 with phosphoric acid or potassium hydroxide. At the start of the test, the pH of each flask is not measured but assumed to be the same as the mineral medium (7.31), in order not to remove any floating undissolved test substance from the test medium by dipping a glass electrode in it. Neutral test substances, even sodium benzoate, were shown not to affect the pH of the medium by more than 0.1 pH unit.
- Suspended solids concentration: 30 mg/L
TEST SYSTEM
- Culturing apparatus: 250 mL flasks
- Number of culture flasks/concentration: 2
- Method used to create aerobic conditions: no data
- Method used to create anaerobic conditions: not applicable
- Measuring equipment: The respirometer used during this study is a SAPROMAT D 12, made by J. M. VOITH GmbH, D-7920 Heidenheim.
- Test performed in closed vessels: yes
- Test performed in open system: no
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes (mineral medium + inoculum)
- Positive control: yes (mineral medium + 100 mg/L reference substance + inoculum)
- Toxicity control: yes (mineral medium + 100 mg/L test chemical + 100 mg/L reference substance + inoculum) - Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- Not applicable
- Test performance:
- No data
- Parameter:
- % degradation (O2 consumption)
- Value:
- 82
- Sampling time:
- 28 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 82
- Sampling time:
- 38 d
- Details on results:
- See tables in "Any other information on results incl. tables" and graph in "Attached background material".
- Results with reference substance:
- 94% biodegradation after 14 days and 97% biodegradation after 28 days. See table 5.2.1/3 in "Any other information on results incl. tables"
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Eucalyptol undergoes 82% biodegradation after 28 days in the test conditions. Biodegradation starts on day 3 and reaches 72% at the end of the 10 -day window (days 3 to 13). The curves obtained with the reference substance alone and with Eucalyptol + reference substance show no toxic effect of Eucalyptol on the micro-organisms at the test concentration.
- Executive summary:
This study was performed according to OECD Guideline 301F with GLP statement.
A measured volume of inoculated mineral medium, containing a known concentration of test substance (100 mg/L) as the nominal sole source of organic carbon, is stirred in a closed flask at a constant temperature (22 +/-1°C) for up to 38 days. The consumption of oxygen is determined by measuring the quantity of oxygen (produced electrolytically) required to maintain constant the gas volume in the respirometer flask. Evolved carbon dioxide is absorbed in soda lime pellets. The amount of oxygen taken up by the microbial population during biodegradation of the test chemical (corrected for uptake by blank inoculum, run in parallel) is expressed as a percentage of ThOD (Theoretical Oxygen Demand, calculated from the elemental composition, assuming that carbon is oxidized to carbon dioxide and hydrogen to water).
As suggested in the guideline, the toxicity of the test chemical for the inoculum is checked. Therefore, a pair of flasks of the volumetric respirometer (SAPROMAT) are filled with mineral medium + test chemical (100 mg/L) + reference substance (sodium benzoate, 100 mg/L) + inoculum and their respirations are recorded as for the other flasks. If they are lower than those of the flasks containing mineral medium + reference substance (100 mg/L) + inoculum, the test chemical can be assumed to be inhibitory to the inoculum used.
Eucalyptol undergoes 82% biodegradation after 28 days (also after 38 days) in the test conditions. Biodegradation starts on day 3 and reaches 72% at the end of the 10 -day window (days 3 to 13). The curves obtained with the reference substance alone and with Eucalyptol + reference substance show no toxic effect of Eucalyptol on the micro-organisms at the test concentration.
In conclusion, Eucalyptol should be regarded as readily biodegradable according to this test.
Referenceopen allclose all
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Please see the attached documents.
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Please see the attached documents.
Table 5.2.1/2: Biological Oxygen Demand and percentage of biodegradation of the test substance
Days : |
3 |
7 |
13 |
21 |
28 |
38 |
||
BOD Sludge |
1rst flask |
B1 |
14.0 |
19.0 |
21.0 |
23.0 |
26.0 |
27.0 |
2ndflask |
B2 |
11.0 |
15.0 |
18.0 |
21.0 |
23.0 |
24.0 |
|
Mean |
B |
12.5 |
17.0 |
19.5 |
22.0 |
24.5 |
25.5 |
|
BOD Test subs. |
1rst flask |
C1 |
72.7 |
150.1 |
219.7 |
249.1 |
258.9 |
259.0 |
2ndflask |
C2 |
90.7 |
171.4 |
238.3 |
263.0 |
267.9 |
267.9 |
|
1rst fl. corr. |
C1-B |
60.2 |
133.1 |
200.2 |
227.1 |
234.4 |
233.5 |
|
2ndfl. Corr. |
C2-B |
78.2 |
154.4 |
218.8 |
241.0 |
243.4 |
242.4 |
|
% degr. |
1rst flask |
D1 |
21 |
46 |
69 |
78 |
81 |
81 |
2ndflask |
D2 |
27 |
53 |
75 |
83 |
84 |
84 |
|
mean |
D |
24 |
50 |
72 |
81 |
82 |
82 |
|
B = (B1 + B2) / 2
D1 = 100 * (C1 - B) / ThOD * [S]
D2 = 100 * (C2 - B) / ThOD * [S]
D = (D1 + D2) / 2
ThOD = 2.90 mg O2/mg
[S] = Initial test substance concentration (mg/L)
Table 5.2.1/3: Biological Oxygen Demand and percentage of biodegradation of the reference substance
Days : |
5 |
7 |
10 |
14 |
21 |
28 |
||
BOD Sludge |
1rst flask |
B1 |
17.0 |
19.0 |
20.0 |
22.0 |
23.0 |
26.0 |
2ndflask |
B2 |
14.0 |
15.0 |
16.0 |
19.0 |
21.0 |
23.0 |
|
Mean |
B |
15.0 |
17.0 |
18.0 |
20.5 |
22.0 |
24.5 |
|
BOD Ref subs. |
1rst flask |
A1 |
141.0 |
158.0 |
168.0 |
176.0 |
180.0 |
185.0 |
2ndflask |
A2 |
145.0 |
162.0 |
172.0 |
178.0 |
182.0 |
186.0 |
|
1rst fl. corr. |
A1-B |
125.5 |
141.0 |
150.0 |
155.5 |
158.0 |
160.5 |
|
2ndfl. Corr. |
A2-B |
129.5 |
145.0 |
154.0 |
157.5 |
160.0 |
161.5 |
|
% degr. |
1rst flask |
D1 |
75 |
85 |
90 |
93 |
95 |
96 |
2ndflask |
D2 |
78 |
87 |
92 |
95 |
96 |
97 |
|
mean |
D |
77 |
86 |
91 |
94 |
95 |
97 |
|
B = (B1 + B2) / 2
D1 = 100 * (A1 - B) / ThOD * [S]
D2 = 100 * (A2 - B) / ThOD * [S]
D = (D1 + D2) / 2
ThOD = 1.67 mg O2/mg
[S] = Initial reference substance concentration (mg/L)
Description of key information
Based on a Weight of Evidence approach with individual data on constituents, the registered substance can be regarded as readily biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
Based on typical composition, 96.1% of the substance is known. Major constituents (above 1%) represent 95.0% of the whole substance.
Individual data about ready biodegradability of major constituents can be found in the table below:
Constituents |
CAS No |
Typical %* |
Biodegradation results |
Reference |
Linalool |
78-70-6 |
42.00 |
Readily biodegradable |
MITI, 1996 |
Camphor |
76-22-2 |
13.00 |
Readily biodegradable |
MITI, 1994 |
1,8-cineol |
470-82-6 |
25.00 |
Readily biodegradable |
Rudio, 1997 |
| α/β -pinene | 80-56-8 and 127 -91-3 | 6.00 | Readily biodegradable | MITI, 2007; and ECHA disseminated dossier of b-pinene |
| limonene | 138-86-3 | 2.00 | Readily biodegradable | MITI, 1980 |
| trans-a-bisabolene | 25532-79-0 | 1.80 | Not Readily biodegradable | QSAR, BioWin v4.10 |
| b-caryophyllene | 87 -44 -5 | 1.00 | Not Readily biodegradable | QSAR, BioWin v4.10 |
| a-terpineol | 98 -55 -5 | 1.20 | Readily biodegradable | MITI, 1978 |
| borneol laevo | 464 -45 -9 | 1.00 | Readily biodegradable | MITI, 1987 |
| b-myrcene | 123 -35 -3 | 1.00 | Readily biodegradable | MITI, 1987 |
| camphene | 79 -92 -5 | 1.00 | Not readily biodegradable | MITI, 1988 |
* Typical composition taking into account constituents above 1%
In total, ca. 90% of the substance is composed by readily biodegradable constituents.
Based on a Weight of Evidence approach, it can therefore be possible to consider that the substance 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.
