Registration Dossier
Registration Dossier
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EC number: 947-717-3 | CAS number: -
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:
- 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:
- 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:
- 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: screening tests
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2017-07-11 to 2017-07-11
- 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[C@]12CCCC(C1CC[C@@]([C@@H]2CC[C@](C)(C=C)O)(C)O)(C)C
- CHEM: (1R,2R,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
- MOL FOR: C20 H36 O2
- MOL WT: 308.51 - 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) = Recalcitrant
Biowin 4 (Primary biodegradation timeframe) = 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:
- 2017-07-12 to 2017-07-12
- 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: CC12CCCC(=C)C1CC(CC2)C(C)(C)O
- MOL FOR: C15 H26 O1
- MOL WT: 222.37 - 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) = 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:
- 2017-07-13 to 2017-07-13
- 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(CCCC2(C1CCC3(C2CCC(O3)(C)C=C)C)C)C
- MOL FOR: C20 H34 O1
- MOL WT: 290.49 - 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) = Recalcitrant
Biowin 4 (Primary biodegradation timeframe) = 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:
- 2017-07-13 to 2017-07-13
- 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: CC(O)(CCC1C(=C)CCC2C(C)(C)CCCC12C)C=C
- CHEM: MANOOL
- MOL FOR: C20 H34 O1
- MOL WT: 290.49 - 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) = Months
Biowin 4 (Primary biodegradation timeframe) = 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:
- 2017-07-17 to 2017-07-17
- 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=CCC2C(C)(CCC3C(C)(C)CCCC32C)O1
- MOL FOR: C18 H30 O1
- MOL WT: 262.44 - 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) = Months
Biowin 4 (Primary biodegradation timeframe) = 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
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 |
Please see the attached documents.
Please see the attached documents.
Please see the attached documents.
Please see the attached documents.
Please see the attached documents.
Description of key information
Based on a weight of evidence approach with data on constituents, the substance Clary sage concrete cannot be considered as readily biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
Additional information
WEIGHT OF EVIDENCE
Based on the typical composition of Clary sage concrete from the Lead Registrant, about 80% of the composition is known and constituents above 1% represent 77.20%.
In total, at least 19% of the whole substance is composed by readily biodegradable constituents (see table below):
Constituents |
CAS No |
% in the mixture* |
Biodegradation results |
Reference in IUCLID 6 |
Linalool |
78-70-6 |
6.00 |
Readily biodegradable |
Linalool, 78-70-6, Biodegradation in water: screening tests, MITI, 1996, RS, W |
Linalyl acetate |
115-95-7 |
12 |
Readily biodegradable |
Linalyl acetate, 115-95-7, Biodegradation in water: screening tests, OECD SIDS, 1991, RS, W |
Sclareol |
515 -03 -7 |
52.00 |
Not Ready biodegradable |
Sclareol, 515-03-7, Biodegradation in water: screening tests, QSAR, Biowinv4.10, RS, W |
terpineol alpha |
98 -55 -5 |
1.00 |
Readily Biodegradable |
alpha-terpineol, 98-55-5, Biodegradation in water: screening tests, MITI, 1978, RS, W |
| Eudesmol | 473 -15 -4 | 1.30 | Not Ready Biodegradable | Eudesmol, 473-15-4, Biodegradation in water: screening tests, QSAR, Biowinv4.10, RS, W |
| Sclareol oxide | 5153 -92 -4 | 2.00 | Not Ready Biodegradable | Sclareol oxide, 5153-92-4, Biodegradation in water: screening tests, QSAR, Biowinv4.10, RS, W |
| Manool oxide | 596 -84 -9 | 1.00 | Not Ready Biodegradable | Manool oxide, 596-84-9, Biodegradation in water: screening tests, QSAR, Biowinv4.10, RS, W |
| Manool | 596 -85 -0 | 1.90 | Not Ready Biodegradable | Manool, 596-85-0, Biodegradation in water: screening tests, QSAR, Biowinv4.10, RS, W |
* % values in the mixtures have been taken from the typical composition supplied by the Lead registrant, taken into account constituents > 1% within the mixture
Therefore, based on a constituents knowledge approach, it cannot be possible to consider that CLARY SAGE CONCRETE 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.
