Registration Dossier
Registration Dossier
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EC number: 289-621-8 | CAS number: 89957-99-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Boswellia papyrifera, Burseraceae.
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:
- 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:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2018-11-08 to 2018-11-08
- 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:
- Version / remarks:
- 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: CCCCCCCCOC(=O)C
- CHEM: octyl acetate
- MOL FOR: C10 H20 O2
- MOL WT: 172.27 - 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:
- readily biodegradable based on QSAR/QSPR prediction
- Details on results:
- Biowin1 (Linear Model Prediction) : Biodegrades Fast
Biowin2 (Non-Linear Model Prediction): Biodegrades Fast
Biowin3 (Ultimate Biodegradation Timeframe): Days-Weeks
Biowin4 (Primary Biodegradation Timeframe): Days
Biowin5 (MITI Linear Model Prediction) : Readily Degradable
Biowin6 (MITI Non-Linear Model Prediction): Readily Degradable
Biowin7 (Anaerobic Model Prediction): Biodegrades Fast
Ready Biodegradability Prediction: YES - Results with reference substance:
- Not applicable.
- Validity criteria fulfilled:
- not applicable
- Interpretation of results:
- readily biodegradable
- Conclusions:
- It is expected that the substance is 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.
Biowin 1, 2, 5 & 6 are the most relevant because they are quantitative models while the others are semi-quatitative.
Therefore, it's expected that the substance is readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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, the test item was readily biodegradable.
- Executive summary:
In a ready biodegradation study performed according to OECD Guideline 301 C, the test item 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, the test item was readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2018-11-09 to 2018-11-09
- 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: CCCCCCCCO
- MOL FOR:C8 H18 O1
- MOL WT: 130.23 - 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:
- readily biodegradable based on QSAR/QSPR prediction
- Details on results:
- Biowin1 (Linear Model Prediction) : Biodegrades Fast
Biowin2 (Non-Linear Model Prediction): Biodegrades Fast
Biowin3 (Ultimate Biodegradation Timeframe): Days-Weeks
Biowin4 (Primary Biodegradation Timeframe): Days
Biowin5 (MITI Linear Model Prediction) : Readily Degradable
Biowin6 (MITI Non-Linear Model Prediction): Readily Degradable
Biowin7 (Anaerobic Model Prediction): Biodegrades Fast
Ready Biodegradability Prediction: YES - Results with reference substance:
- Not applicable.
- Validity criteria fulfilled:
- not applicable
- Interpretation of results:
- readily biodegradable
- Conclusions:
- It is expected that the substance is 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.
Biowin 1, 2, 5 & 6 are the most relevant because they are quantitative models while the others are semi-quatitative.
Therefore, it's expected that the substance is readily biodegradable.
Referenceopen allclose all
None
Please see the attached documents.
None
Please see the attached documents.
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 the typical composition, the substance is composed at 78.2% of readily biodegradable constituents.
In total, ca. 78.2% 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.
