Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Biodegradation in water: screening tests
Administrative data
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17th December 2019 - 15th January, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of 2,2'-(1,3-phenylenebis(oxy))diethanol with 2-(phenoxymethyl)oxirane and 2-isocyanatoethyl methacrylate
- Cas Number:
- 1431303-59-1
- Molecular formula:
- Not assigned for UVCB substance.
- IUPAC Name:
- Reaction products of 2,2'-(1,3-phenylenebis(oxy))diethanol with 2-(phenoxymethyl)oxirane and 2-isocyanatoethyl methacrylate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 3M, 6252020
- Expiration date of the lot/batch: September 2021
- Purity test date: 21st October 2019
- Purity: 100% (MTDID 58376), Complex mixture of ER-1GP IEM, ER-2GP IEM, ER-3GP IEM, ER-4GP IEM
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in a dark, ventilated cabinet in the original container.
- Stability under storage conditions: Stable
Study design
- 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): Sludge was obtained from Wareham Wastewater Treatment Plant, Wareham Massachusetts, receiving predominantly domestic sludge. Collected 16th December, 2019.
- Preparation of inoculum for exposure: Sludge was passed through a 2mm sieve and centrifuged for 10 minutes (1000 rpm). Supernatant was discarded and the sludge was washed with mineral medium. The sludge was then centrifuged again and the supernatant discarded. The moisture content was determined to be 94.36%, for a percent dry solids id 5.64%.
- Pretreatment: Inoculum solution with 15 mg dry solids/mL was prepared by diluting 53.19 g wet sludge to 200mL mineral medium and stirred with a PTFE-coated magnetic bar until use (22°C).
- Concentration of sludge: 30 mg solids/L. Initial carbon content of solution was 0.93 mg/L. - Duration of test (contact time):
- 28 d
Initial test substance concentration
- Initial conc.:
- 10 mg/L
- Based on:
- TOC
Parameter followed for biodegradation estimation
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Standard OECD 301B test medium
- Additional substrate: none
- Test temperature: 20-21.1°C
- pH: 7.4
- pH adjusted: No
- Suspended solids concentration: 30 mg/L
- Continuous darkness: Yes
TEST SYSTEM
- Culturing apparatus: 4L glass bottle with rubber stopper
- Number of culture flasks/concentration: two
- Method used to create aerobic conditions: Vessels were attached to CO2-free compressed air gas tank and aerated under positive pressure.
- Measuring equipment:Two CO2 effluent gas traps. The first with 200mL of 0.2N KOH traps and the second with 100 mL of 0.2N KOH. The samples removed from the KOH trap were analysed using a Shimadzu TOC V-CPH or TOC-L/ASI-L/SSM Carbon Analyzer.
- Test performed in open system: No
SAMPLING
- Sampling frequency: Days 1, 3, 6, 10, 14, 17, 21, 24, 27, 28 and 29
- Sampling method: 7mL of sludge solution was removed from the first KOH carbon dioxide trap on each test and analyzed for CO2 evolution.
- Sample storage before analysis: None
CONTROL AND BLANK SYSTEM
- Inoculum blank: duplicate
- Procedural control: 2991 mL mineral medium, 6.0 mL sludge inoculum, 3mL sodium benzoate
- Toxicity Control: 2991 mL mineral medium, 6.0 mL sludge inoculum, 10mL C/L test substance, 10 mg C/L sodium benzoate
Reference substance
- Reference substance:
- benzoic acid, sodium salt
- Remarks:
- 10 mg C/L
Results and discussion
% Degradation
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 4.88
- Sampling time:
- 28 d
- Details on results:
- Detailed results on net percent carbon dioxide evolution of the test substance are provided in Table 2 and are graphically depicted in the illustration.
Detailed results on net percent carbon dioxide evolution by the reference substance and in the toxicity control are provided in Table 2.
Raw data results on inorganic carbon evolution in the blank control are provided in Table 1. Cumulative CO2 evolution in blanks was calculated using formulae shown below Table 1. Mean CO2 evolution in controls was 25.89 mg/L
The reference substance was 74.13% degraded by day 14.
Biodegradation in the toxicity control was 35.67% by day 14 and is therefore MTDID 58376 is not toxic to activated sludge.
Any other information on results incl. tables
Table 1. MTDID 58376 Determination of the Biodegradability- Total Inorganic Carbon (mg C/L) Measured in Potassium Hydroxide Trapping Solutions.
Replicate |
TIC (mg C/L) Day 1 |
TIC (mg C/L) Day 3 |
TIC (mg C/L) Day 6 |
TIC (mg C/L) Day 10 |
TIC (mg C/L) Day 14 |
TIC (mg C/L) Day 17 |
TIC (mg C/L) Day 21 |
TIC (mg C/L) Day 24 |
TIC (mg C/L) Day 27 |
TIC (mg C/L) Day 28 |
TIC (mg C/L) Day 29- Trap 1 |
TIC (mg C/L) Day 29- Trap 2 |
Test suspension A |
9.584 |
17.00 |
35.73 |
53.71 |
68.73 |
85.26 |
101.9 |
110.4 |
117.5 |
123.6 |
130.1 |
20.54 |
Test suspension B |
10.20 |
18.32 |
34.83 |
49.65 |
62.93 |
73.36 |
86.72 |
95.01 |
101.7 |
104.9 |
114.2 |
19.41 |
Inoculum Blank A |
12.65 |
19.21 |
33.93 |
50.29 |
61.75 |
74.41 |
88.23 |
96.85 |
102.3 |
107.6 |
121.3 |
16.82 |
Inoculum Blank B |
10.25 |
18.52 |
35.63 |
53.89 |
67.86 |
78.40 |
86.08 |
91.42 |
96.69 |
100.8 |
109.8 |
16.22 |
Procedural control * |
11.77 |
49.08 |
117.9 |
154.8 |
185.3 |
202.2 |
221.0 |
238.3 |
242.4 |
252.6 |
261.2 |
20.64 |
Toxicity control |
14.14 |
63.03 |
117.3 |
149.7 |
180.0 |
206.2 |
228.7 |
240.4 |
245.7 |
256.2 |
263.0 |
26.38 |
* sodium benzoate
Note: The following equation was used to determine evolved CO2:
mg CO2 from test vessel=((TIC mg/L x 3.667) x vol. KOH Tx[L])+ Sum [(TIC mg/L in previous aliquots removed x 0.007 L x 3.667)]
Where: 3.667 is the conversion factor (44/12) for carbon to carbon dioxide.
Vol. KOH Tx is the volume of KOH trap at the particular sampling interval.
0.007 L is the KOH sampling volume (7.0 mL)
Table 2. MTDID 58376 Determination of the Biodegradability- Cumulative Net Percent CO2 Evolved from the Test Vessels (Ultimate Biodegradation)
Vessel |
Replicate |
Day 1 |
Day 3 |
Day 6 |
Day 10 |
Day 14 |
Day 17 |
Day 21 |
Day 24 |
Day 27 |
Day 28 |
Day 29 |
1 |
Test suspension A |
-1.24 |
-1.24 |
0.50 |
0.90 |
2.22 |
4.93 |
8.04 |
8.80 |
9.64 |
10.27 |
9.51 |
2 |
Test suspension B |
-0.83 |
-0.38 |
-0.01 |
-1.50 |
-1.17 |
-1.82 |
-0.44 |
0.22 |
0.86 |
0.17 |
0.24 |
|
Mean |
-1.04 |
-0.81 |
0.25 |
-0.30 |
0.53 |
1.56 |
3.80 |
4.51 |
5.25 |
5.22 |
4.88 |
|
Std Dev |
0.29 |
0.61 |
0.36 |
1.70 |
2.40 |
4.77 |
6.00 |
6.07 |
6.21 |
7.15 |
6.55 |
5 |
Procedural control |
0.21 |
19.45 |
52.25 |
63.94 |
74.13 |
77.05 |
81.29 |
86.48 |
85.88 |
88.39 |
88.57 |
6 |
Toxicity control |
0.90 |
14.24 |
26.13 |
30.63 |
35.67 |
39.69 |
42.78 |
43.97 |
43.95 |
45.28 |
45.93 |
The following equation was used to determine % biodegradation:
% Ultimate Biodegradability= (mg CO2 produced/ mg TOC added x 3.667) x 100
Results were calculated using the actual analytical (unrounded) results and not the rounded values presented in this table. All values were corrected for mean inoculum blank CO2 production.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Toxicity control degradation >25% by 14d (35.67%), ref substance degradation >60% by 14d (74.13%), <5% inorganic C in medium at test start (4.3%), diff in test substance degradation <20% (3.39% 14d, 9.27% 29d), CO2 evol in controls ≤40 mg/L (25.89 mg/L)
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- MTDID 58376 was 4.88% biodegraded in a 28-day OECD 301B test.
- Executive summary:
Ready biodegradability of MTDID 58376 was assessed according to OECD 301B guidelines. Duplicate flasks were used for blanks and the test substance, with single flasks for procedural control (sodium benzoate), and toxicity control samples. The reference substance was biodegraded 74.13% by day 14 and 88.39% by day 28. The test substance was biodegraded (4.88%) by day 28. Thus, MTDID 58376 is not considered readily biodegradable and is not toxic to microorganisms in activated sludge (36% degradation in toxicity control). The test was conducted according to internationally accept guidelines and is GLP compliant. It is reliable without restrictions and is suitable for Risk Assessment, Classification & Labelling, and PBT Analysis.
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.