Registration Dossier
Registration Dossier
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EC number: 907-131-0 | 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- non-GLP, only one replicate
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)
- Version / remarks:
- version: 29 Dec 1992
- Deviations:
- yes
- Remarks:
- one replicate only
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Version / remarks:
- version: 1993
- Deviations:
- yes
- Remarks:
- one replicate only
- Qualifier:
- according to guideline
- Guideline:
- ISO DIS 9439 (Ultimate Aerobic Biodegradability - Method by Analysis of Released Carbon Dioxide)
- Version / remarks:
- version: 1990
- Deviations:
- yes
- Remarks:
- one replicate only
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): laboratory WWTP
- Laboratory culture: yes
- Method of cultivation: fed with municipal and synthetic sewage (80:20 v/v%)
- Concentration of sludge: 30 mg/L - Duration of test (contact time):
- 28 d
- Initial conc.:
- 44 mg/L
- Based on:
- act. ingr.
- Initial conc.:
- 19.6 mg/L
- Based on:
- DOC
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Parameter followed for biodegradation estimation:
- DOC removal
- Reference substance:
- diethylene glycol
- Remarks:
- Results shown here are from a test with diethylene glycol as reference substance
- Parameter:
- % degradation (DOC removal)
- Value:
- 99
- Sampling time:
- 28 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 71
- Sampling time:
- 28 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 0
- Sampling time:
- 8 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 22
- Sampling time:
- 13 d
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 65
- Sampling time:
- 23 d
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable, but failing 10-day window
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-A (Determination of the "Ready" Biodegradability - Dissolved Organic Carbon (DOC) Die-Away Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 A (Ready Biodegradability: DOC Die Away Test)
- Qualifier:
- according to guideline
- Guideline:
- ISO 7827 (Evaluation in an Aqueous Medium of the "Ultimate" Aerobic Biodegradability of Organic Compounds - Method by Analysis of Dissolved Organic Carbon (DOC))
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): laboratory WWTP
- Laboratory culture: yes
- Method of cultivation: fed with municipal and synthetic sewage (80:20 v%)
- Concentration of sludge: 30 mg/L - Duration of test (contact time):
- 28 d
- Initial conc.:
- 45 mg/L
- Based on:
- act. ingr.
- Initial conc.:
- 20 mg/L
- Based on:
- DOC
- Parameter followed for biodegradation estimation:
- DOC removal
- Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (DOC removal)
- Value:
- 102
- Sampling time:
- 28 d
- Parameter:
- % degradation (DOC removal)
- Value:
- -12
- Sampling time:
- 4 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 11
- Sampling time:
- 5 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 67
- Sampling time:
- 15 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 80
- Sampling time:
- 18 d
- Results with reference substance:
- Degradation: 94% after 3 days
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable, but failing 10-day window
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-A (Determination of the "Ready" Biodegradability - Dissolved Organic Carbon (DOC) Die-Away Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 A (Ready Biodegradability: DOC Die Away Test)
- Qualifier:
- according to guideline
- Guideline:
- ISO 7827 (Evaluation in an Aqueous Medium of the "Ultimate" Aerobic Biodegradability of Organic Compounds - Method by Analysis of Dissolved Organic Carbon (DOC))
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): laboratory WWTP
- Laboratory culture: yes
- Method of cultivation: fed with municipal and synthetic sewage (80:20 v%)
- Concentration of sludge: 30 mg/L - Duration of test (contact time):
- 28 d
- Initial conc.:
- 45 mg/L
- Based on:
- act. ingr.
- Initial conc.:
- 20 mg/L
- Based on:
- DOC
- Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (DOC removal)
- Value:
- 101
- Sampling time:
- 28 d
- Results with reference substance:
- Degradation: 96% after 3 days
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable, but failing 10-day window
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached justification document 'update_Category Justification_ethylene glycol and higher glycols_2022.doc'
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
See above.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See above.
3. ANALOGUE APPROACH JUSTIFICATION
See above.
4. DATA MATRIX
See above. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Parameter:
- % degradation (DOC removal)
- Value:
- 101
- Sampling time:
- 28 d
- Remarks on result:
- other: readily biodegradable, but failing 10-day window
- Remarks:
- CAS 111-46-6, 301A, BASF AG, 1994
- Parameter:
- % degradation (DOC removal)
- Value:
- 99
- Sampling time:
- 28 d
- Remarks on result:
- other: readily biodegradable, but failing 10-day window
- Remarks:
- CAS 111-46-6, 301B, BASF AG, 1995
- Parameter:
- % degradation (DOC removal)
- Value:
- 102
- Sampling time:
- 28 d
- Remarks on result:
- other: readily biodegradable, but failing 10-day window
- Remarks:
- CAS 111-46-6, 301A, BASF AG, 1995
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2022
- 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
- Justification for type of information:
- 1. SOFTWARE
OASIS Catalogic v.5.15.2
2. MODEL (incl. version number)
CATALOGIC 301C v.12.17
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
See section 'Test Material'.
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF.
5. APPLICABILITY DOMAIN
See attached QPRF.
6. ADEQUACY OF THE RESULT
- The model is scientifically valid (see attached QMRF).
- The model estimates the biodegradability of a substance as well as its primary half-life, ultimate half-life, and its metabolites and their quantitative distribution.
Information on the degradation products are required for substances manufactured or imported in quantities of > 100 t/y or more. According to column 2 of REACH Annex IX, testing is not required if the substance is highly insoluble in water, or the substance is readily biodegradable.
- See attached QPRF for reliability assessment. - Principles of method if other than guideline:
- Estimation of ready biodegradation in water using CATALOGIC v5.15.2 BOD 28 days MITI (OECD 301C) v12.17
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Duration of test (contact time):
- 28 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 99
- Sampling time:
- 28 d
- Remarks on result:
- readily biodegradable based on QSAR/QSPR prediction
- Remarks:
- The substance is in the applicability domain of the model.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Endpoint:
- biodegradation in water: screening tests
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- ; basic data given: comparable to guideline studies
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 302 C (Inherent Biodegradability: Modified MITI Test (II))
- GLP compliance:
- not specified
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Sludge was taken from 10 different sites in Japan (municipal STPs, industrial STPs, lakes, rivers and bays)
- Laboratory culture: yes
- Method of cultivation: fresh and old sludge was mixed at regular intervals under sufficient aeration; about 30 minutes after ceasing the aeration the supernatant corresponding to about 1/3 of whole volume was removed. Then the equal volume of dechlorination water was added to the remaining portion and aerated again, followed by addition of synthetic sewage* (0.1% w/v). This procedure was repeated once every day. The culturing was carried out at 25 °C.
- Storage conditions: see above
- Storage length: see above
- Preparation of inoculum for exposure: see above
- Pretreatment: see above
- Concentration of sludge: 100 mg/L
* Synthetic sewage: each 5% (w/v) glucose, peptone and monopotassium phosphate were dissolved in dechlorinatian water, adjusted to pH 7.0 ± 1.0 with sodium hydroxide. - Duration of test (contact time):
- 4 wk
- Initial conc.:
- 30 mg/L
- Based on:
- act. ingr.
- Parameter followed for biodegradation estimation:
- test mat. analysis
- Remarks:
- Analysis performed with gas chromatography (GC)
- Parameter followed for biodegradation estimation:
- O2 consumption
- Parameter followed for biodegradation estimation:
- TOC removal
- Details on study design:
- TEST CONDITIONS
- Composition of medium: basal mineral culture medium (according to the guideline)
- Additional substrate: no
- Solubilising agent (type and concentration if used): not necessary
- Continuous darkness: yes
- Test temperature: 25 °C +/- 1°C
- pH: 7.0
- pH adjusted: yes
- Aeration of dilution water: pre-filtered air was used for aeration
- Suspended solids concentration: 30 mg/L
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Abiotic sterile control: yes
- Toxicity control: yes (Aniline)
TEST SYSTEM
- Culturing apparatus: 300 mL vessels
- Number of culture flasks/concentration: 3 (according to the guideline)
- Measuring equipment: Closed system oxygen consumption measuring apparatus
- Details of trap for CO2 and volatile organics if used: Soda lime No.1 (extra pure reagent) - Parameter:
- % degradation (O2 consumption)
- Value:
- 90
- Sampling time:
- 28 d
- Remarks on result:
- other: BOD/ThOD
- Parameter:
- % degradation (TOC removal)
- Value:
- 88
- Sampling time:
- 28 d
- Parameter:
- % degradation (test mat. analysis)
- Value:
- 90
- Sampling time:
- 28 d
- Remarks on result:
- other: GC
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- inherently biodegradable
- Conclusions:
- Diethylene glycol is inherently biodegradable in the MITI (II) - Test.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2022
- 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
- Justification for type of information:
- 1. SOFTWARE
OASIS Catalogic v.5.15.2
2. MODEL (incl. version number)
CATALOGIC 301C v.12.17
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
See section 'Test Material'.
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF.
5. APPLICABILITY DOMAIN
See attached QPRF.
6. ADEQUACY OF THE RESULT
- The model is scientifically valid (see attached QMRF).
- The model estimates the biodegradability of a substance as well as its primary half-life, ultimate half-life, and its metabolites and their quantitative distribution.
Information on the degradation products are required for substances manufactured or imported in quantities of > 100 t/y or more. According to column 2 of REACH Annex IX, testing is not required if the substance is highly insoluble in water, or the substance is readily biodegradable.
- See attached QPRF for reliability assessment. - Principles of method if other than guideline:
- Estimation of ready biodegradation in water using CATALOGIC v5.15.2 BOD 28 days MITI (OECD 301C) v12.17
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Duration of test (contact time):
- 28 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 98
- Sampling time:
- 28 d
- Remarks on result:
- readily biodegradable based on QSAR/QSPR prediction
- Remarks:
- The substance is in the applicability domain of the model.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 A (Ready Biodegradability: DOC Die Away Test)
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Activated sludge from laboratory treatment plant, feed with domestic and synthetic effluent.
- 30 mg/l (dry substance). - Duration of test (contact time):
- 20 d
- Initial conc.:
- 20 mg/L
- Based on:
- DOC
- Initial conc.:
- 41.5 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- DOC removal
- Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (DOC removal)
- Value:
- 90 - 100
- Sampling time:
- 20 d
- Interpretation of results:
- readily biodegradable
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2022
- 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
- Justification for type of information:
- 1. SOFTWARE
OASIS Catalogic v.5.15.2
2. MODEL (incl. version number)
CATALOGIC 301C v.12.17
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
See section 'Test Material'.
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF.
5. APPLICABILITY DOMAIN
See attached QPRF.
6. ADEQUACY OF THE RESULT
- The model is scientifically valid (see attached QMRF).
- The model estimates the biodegradability of a substance as well as its primary half-life, ultimate half-life, and its metabolites and their quantitative distribution.
Information on the degradation products are required for substances manufactured or imported in quantities of > 100 t/y or more. According to column 2 of REACH Annex IX, testing is not required if the substance is highly insoluble in water, or the substance is readily biodegradable.
- See attached QPRF for reliability assessment. - Principles of method if other than guideline:
- Estimation of ready biodegradation in water using CATALOGIC v5.15.2 BOD 28 days MITI (OECD 301C) v12.17
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Duration of test (contact time):
- 28 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 97
- Sampling time:
- 28 d
- Remarks on result:
- readily biodegradable based on QSAR/QSPR prediction
- Remarks:
- The substance is in the applicability domain of the model.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2022
- 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
- Justification for type of information:
- 1. SOFTWARE
OASIS Catalogic v.5.15.2
2. MODEL (incl. version number)
CATALOGIC 301C v.12.17
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
See section 'Test Material'.
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF.
5. APPLICABILITY DOMAIN
See attached QPRF.
6. ADEQUACY OF THE RESULT
- The model is scientifically valid (see attached QMRF).
- The model estimates the biodegradability of a substance as well as its primary half-life, ultimate half-life, and its metabolites and their quantitative distribution.
Information on the degradation products are required for substances manufactured or imported in quantities of > 100 t/y or more. According to column 2 of REACH Annex IX, testing is not required if the substance is highly insoluble in water, or the substance is readily biodegradable.
- See attached QPRF for reliability assessment. - Principles of method if other than guideline:
- Estimation of ready biodegradation in water using CATALOGIC v5.15.2 BOD 28 days MITI (OECD 301C) v12.17
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Duration of test (contact time):
- 28 d
- Parameter:
- % degradation (O2 consumption)
- Value:
- 96
- Sampling time:
- 28 d
- Remarks on result:
- readily biodegradable based on QSAR/QSPR prediction
- Remarks:
- The substance is in the applicability domain of the model.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached justification document 'update_Category Justification_ethylene glycol and higher glycols_2022.doc'
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
See above.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See above.
3. ANALOGUE APPROACH JUSTIFICATION
See above.
4. DATA MATRIX
See above. - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Parameter:
- % degradation (DOC removal)
- Value:
- > 90 - < 100
- Sampling time:
- 20 d
- Remarks on result:
- other: readily biodegradable
- Remarks:
- CAS 112-60-7, 301A, BASF AG, 1995
- Parameter:
- % degradation (O2 consumption)
- Value:
- 90
- Sampling time:
- 28 d
- Remarks on result:
- other: inherently biodegradable
- Remarks:
- CAS 111-46-6, 302C, MITI, 1989
- Parameter:
- % degradation (O2 consumption)
- Value:
- 98
- Sampling time:
- 28 d
- Remarks on result:
- readily biodegradable based on QSAR/QSPR prediction
- Remarks:
- CAS 112-27-6, in AD
- Parameter:
- % degradation (O2 consumption)
- Value:
- 97
- Sampling time:
- 28 d
- Remarks on result:
- readily biodegradable based on QSAR/QSPR prediction
- Remarks:
- in AD, CAS 112-60-7
- Parameter:
- % degradation (O2 consumption)
- Value:
- 99
- Sampling time:
- 28 d
- Remarks on result:
- readily biodegradable based on QSAR/QSPR prediction
- Remarks:
- CAS 111-46-6, in AD
- Parameter:
- % degradation (O2 consumption)
- Value:
- 96
- Sampling time:
- 28 d
- Remarks on result:
- readily biodegradable based on QSAR/QSPR prediction
- Remarks:
- CAS 4792-15-8, in AD
Referenceopen allclose all
Degradation kinetics:
Duration |
Degradation (% CO2/ThCO2) |
Days |
Reference substance = Diethylene glycol (CAS 111-46-6) |
0 |
0 |
1 |
0 |
5 |
-2 |
8 |
0 |
13 |
22 |
16 |
43 |
19 |
56 |
23 |
65 |
27 |
65 |
28 |
71 |
DOC (28 d) |
99 |
Degradation kinetics:
Duration |
Degradation (%, based on DOC removal) |
|||
Days |
Reference substance |
Test substance |
||
Rep. 1 |
Rep. 2 |
Mean |
||
0 |
-3 |
0 |
0 |
0 |
1 |
87 |
-14 |
-10 |
-12 |
2 |
94 |
-8 |
-9 |
-9 |
3 |
100 |
-1 |
3 |
1 |
4 |
100 |
-19 |
-4 |
-12 |
5 |
100 |
11 |
10 |
11 |
6 |
100 |
12 |
12 |
12 |
7 |
100 |
11 |
16 |
14 |
9 |
101 |
8 |
24 |
16 |
12 |
100 |
55 |
46 |
51 |
15 |
99 |
73 |
60 |
67 |
18 |
106 |
85 |
74 |
80 |
22 |
102 |
95 |
86 |
91 |
25 |
100 |
98 |
91 |
95 |
27 |
107 |
106 |
106 |
106 |
28 |
101 |
102 |
102 |
102 |
Degradation kinetics:
Days |
DOC elimination (%) |
||||
KS |
AK |
PS1 |
PS2 |
PS mean |
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
23 |
1 |
3 |
4 |
4 |
3 |
96 |
-2 |
-1 |
0 |
-1 |
7 |
100 |
-4 |
17 |
18 |
18 |
10 |
99 |
-6 |
31 |
32 |
32 |
14 |
100 |
-1 |
60 |
62 |
61 |
17 |
100 |
-7 |
73 |
74 |
74 |
20 |
99 |
-6 |
84 |
83 |
85 |
23 |
100 |
-4 |
93 |
95 |
94 |
25 |
101 |
-1 |
102 |
103 |
103 |
27 |
100 |
-3 |
99 |
100 |
100 |
28 |
100 |
-9 |
100 |
101 |
101 |
KS: reference substance
AK: adsorption control
PS: test substance (replicate 1 and 2)
Concomitant predictions:
Ready degradable
Primary Half Life = < 1 day
Ultimate Half Life = 3.92 day
Predicted value (model result):
O2 -consumption (BOD) = 0.99
The original source (NITE, 2008) states as result "readily biodegradable". According to OECD criteria, the MITI (II)-Test (OECD TG 302C) is a test on inherent biodegradability. Therefore, diethylene glycol is inherently biodegradable.
Concomitant predictions:
Ready degradable
Primary Half Life = < 1 day
Ultimate Half Life = 4.76 day
Predicted value (model result):
O2 -consumption (BOD) = 0.98
VALIDATION CRITERIA
The test was valid (degradation of the control substance was 90-100 percent DOC after 4 days).
DEGRADATION OF THE TEST SUBSTANCE
adaption phase: 1 day
log phase: 19 days
adsorption of sludge: <10% after 1 day
the 10-day window was fulfilled
Kinetic of test substance (in %):
= 0 after 1 day(s)
= 20 after 4 day(s)
= 52 after 8 day(s)
= 78 after 13 day(s)
= 100 after 20 day(s)
Kinetic of control substance (in %):
= 77 after 1 day(s)
= 99 after 4 day(s)
Concomitant predictions:
Ready degradable
Primary Half Life = < 1 day
Ultimate Half Life = 5.30 day
Predicted value (model result):
O2 -consumption (BOD) = 0.97
Concomitant predictions:
Ready degradable
Primary Half Life = < 1 day
Ultimate Half Life = 5.92 day
Predicted value (model result):
O2 -consumption (BOD) = 0.96
Description of key information
Readily biodegradable (according to OECD criteria).
Key value for chemical safety assessment
Additional information
QSAR-disclaimer
In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met.
According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.
The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and, therefore, the endpoint(s) sufficiently covered and suitable for risk assessment.
Assessment
The substance is a multi-constituent substance. The main constituents of Mixed Glycols (EC 907-131-0) are triethylene glycol (TGE, CAS 112-27-6, 10-80% w/w) and tetraethylene glycol (Tetra-EG, CAS 112-60-7, 10-80% w/w). Therefore, the assessment of the substance’s biodegradation in water is based on the available data for the main constituents. Moreover, read-across approach was performed. This read-across approach consists of data which are available for structurally similar substances CAS 111-46-6 and CAS 4792-15-8.
Several results on the ready biodegradability of the diethylene glycol (DEG, CAS 111 -46 -6) are available. According to the available study reports, the substance fulfils the ready biodegradability criteria within the 28-d test period; however, the 10-day window criterion is failed in all the available studies (301A BASF AG 1995, 1994, 301B BASF AG, 1995). DEG can be assessed as „biodegradable“ or „readily biodegradable, but failing the 10-d window“.
Additionally, the inherent biodegradability of DEG is supported by an OECD 302C study (NITE, 2017).
Moreover, estimated QSAR data are also available for substances. According to a QSAR calculation using OASIS CATALOGIC v5.15.2, OECD 301C v12.17 the biodegradation of CAS 112-27-6 and CAS 112-60-7 were determined to be 98% and 97% related to O2 consumption after 28 days respectively (BASF SE, 2022). The biodegradation of structurally similar substances CAS 111-46-6 and CAS 4792-15-8 were estimated to be 99% and 96% respectively (BASF SE, 2022).
Overall, based on the available estimated and read-across data it can be concluded, that the substance (EC 907-131-0) is readily biodegradable (according to OECD criteria).
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.
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