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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
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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
- Study period:
- 2021-07-27 to 2021-08-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Version / remarks:
- Adopted 1981, Revised 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge: Municipal waste water treatment plant
- Storage conditions: Activated sludge was continuously aerated at room temperature and
under laboratory diffused light until test start.
- Storage duration: max. 1 day
- Preparation of inoculum for exposure: Right before inoculation, the activated sludge was mixed
thoroughly to ensure homogeneity. For dry matter determination, 3 aliquots of 250 mL each were filtered under reduced pressure and dried at 105 °C. The dry substance determined was 2.08 g/L, from which 3.00 g dry substance/L was prepared by removing the supernatant solution. Within one day, the sludge was sampled and its dry weight was determined. After concentrating the activated sludge, the test medium was inoculated and aerated with CO2-free air overnight.
- Concentration of sludge: 30 mg/L - Duration of test (contact time):
- 29 d
- Initial conc.:
- 299.6 mg/L
- Based on:
- test mat.
- Details on study design:
- TEST CONDITIONS
- Composition of medium and pH: see 'Any other information on materials and methods incl. tables'
- Test temperature: 19.37 – 20.97 °C with a mean temperature of 20.26 °C
- pH adjusted: not reported
- Suspended solids concentration: 30 mg suspended solids/L
TEST SYSTEM
- Culturing apparatus: temperature monitored laboratory environment
- Number of culture flasks/concentration: Test item group (test item and inoculum): 3 replicates
- Method used to create aerobic conditions: aeration
- Measuring equipment: Titration
- Details of trap for CO2: At intervals, the first trap in each train was disconnected and removed for titration with hydrochloric acid (0.05 M) to determine the residual hydroxide concentration. The second and third traps were moved up one position and a new bottle containing a barium hydroxide Ba(OH)2 solution attached to the end of the train.
Titrations were performed after 2, 5, 7, 9, 15, 23, 28, and 29 days after treatment. On day 28, the test vessels were opened and the pH measured. Each mixture was then acidified by adding 1.00 mL 37 % hydrochloric acid (HCl). The vessels were then re-sealed and the aeration continued overnight to purge any residual dissolved CO2 and carbonates before titrating all the remaining trap bottles of day 29.
CONTROL AND BLANK SYSTEM
- Inoculum blank (inoculum): 2 replicates
- Toxicity control (test item, reference item and inoculum): 1 replicate
- Other: Reference control group (reference item and inoculum): 2 replicates
- Reference substance:
- benzoic acid, sodium salt
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 62
- Sampling time:
- 28 d
- Details on results:
- Biological results:
The reference item attained a degradation of 74 % after 28 d of exposure while the the test item showed a degradation of 62 % in the same period. After purging the carbon dioxide by adding concentrated hydrochloric acid from day 28 to 29, the reference substance was degraded by 74 % and the test item by 66 % respectively.
Although biodegradation of the test item was > 60 % after 28 d, this occurred outside the 10-d window (i.e. later than 10 d after degradation first reached 10 %) in the test item replicates.
In order to account for potential toxicity of the test item a toxicity control was conducted. No toxic effects can be assumed if at least 50 % degradation based on the reference or > 25 % in total within 14 d (assuming the reference and test items are dosed at the same C equivalent concentrations). In the toxicity control, biodegradation amounted to 54 % within 9 d and 63 % within 15 d, which is within the test guideline threshold of > 25 % after 14 d based on the reference control. Furthermore, biodegradation of the toxicity control amounted to 67 % after 28 d, which is > 80 % after 28 d based on the reference control.
The degradation of the test item increased to 10 % after day 2 and accounted for 33 % at the end of the 10-d window and reached finally 62% after day 28 and 66 % after day 29 respectively. Thus, IPEMA failed to degrade quickly enough to satisfy the 10-d window and qualify for classification as readily biodegradable because of this effect in present study. - Results with reference substance:
- Pass level of the reference control group:
Reference item had to reach the pass level (60 %) within 14 d. In this study the degradation exceeded 60 % at day 9 in both reference item replicates. - Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The ready biodegradability of IPEMA was assessed with the CO2 Evolution Test according to OECD Guideline 301 B. IPEMA was tested at a nominal concentration of 15 mg carbon/L.
The following biodegradation was determined at the end of the 28-d period:
IPEMA (test item): 62 %
Sodium benzoate (reference item): >60 %
Since the pass value of > 60 % was reached for the test item within 28 d, but not within the 10-d window (i.e. within 10 d from the time when biodegradation first reached 10 %) IPEMA cannot be considered to be readily biodegradable according to OECD guideline 301 B.
The test performance of the toxicity control group did not reveal any potential transient inhibition of microbial activity that may have interfered with the biodegradation of the test item under the conditions of this test. The validity criteria were met by the test.
Reference
Validity criteria:
Replicate variability of the test item group:
The difference of extremes in replicate values, for the removal of the test item at the plateau, at the end of the test or at the end of the 10-d window, should be less than 20 %. The divergence was < 20 % between the test item replicates at day 28.
Pass level of the reference control group:
Reference item had to reach the pass level (60 %) within 14 d. In this study the degradation exceeded 60 % at day 9 in both reference item replicates.
Toxicity control group:
If in the toxicity control, containing both the test item and a reference item, degradation is less than 25 % within 14 d, the test item can be assumed to be inhibitory. In the toxicity control which contained test item and reference item, biodegradation amounted from 54 % at day 9 to 63 % at day 14. This is higher than the 25 % trigger set by the test guideline.
Inoculum control:
CO2 consumption in inoculum control should not exceed 70 mg/L after 28 d. In this study the mean carbon dioxide production recorded in the control vessels amounted to 55.2 mg/L after 28 d.
Pass Levels and Overall Degradation
Group | < 20 % difference in replicates |
Reference control > 60 % by day 14 | CO2 in Inoculum control < 70 mg/L by day 28 | pH range within 6.0-8.5 | Maximum mean degradation At day 28 (29) |
Inoculum control group | Yes | - | Yes | Yes | - |
Reference control group | Yes | Yes (already at day 9) | - | Yes | 74 (74) |
Test item group |
Yes |
- |
- |
Yes |
62 (66) |
Toxic control group |
- |
- |
- |
Yes |
67 (68) |
- Not applicable
pH-Values
Group | Day 28 |
Inoculum control 1 | 7.5 |
Inoculum control 2 | 7.5 |
Reference control 1 | 7.7 |
Reference control 2 | 7.7 |
Test item 1 | 7.5 |
Test item 2 | 7.6 |
Test item 3 | 7.6 |
Toxic control | 7.6 |
Individual Daily Values for Cumulative Carbon Dioxide Production
| Test item group | Reference control group | Inoculum control group | Toxicity Control group | ||||
Time in d | Replicate 1 | Replicate 2 | Replicate 3 | Replicate 1 | Replicate 2 | Replicate 1 | Replicate 2 | Replicate 1 |
in mg/1.5L per vessel | ||||||||
0 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
2 | 16.2 | 15.3 | 18.8 | 39.3 | 30.8 | 9.08 | 7.98 | 31.1 |
5 | 33.6 | 44.8 | 23.2 | 34.9 | 36.0 | 25.0 | 18.4 | 34.4 |
7 | 16.8 | 15.4 | 15.1 | 19.5 | 18.8 | 13.8 | 9.63 | 18.0 |
9 | 9.49 | 8.53 | 12.7 | 8.80 | 13.3 | 7.56 | 7.84 | 10.3 |
15 | 5.36 | 8.80 | 16.2 | 15.4 | 24.5 | 16.1 | 12.9 | 22.1 |
23 | 19.7 | 25.3 | 35.3 | 11.3 | 19.1 | 14.3 | 12.2 | 15.5 |
28 | 15.1 | 16.8 | 17.2 | 6.46 | 8.66 | 6.19 | 6.88 | 6.74 |
29 | 10.3 | 6.33 | 6.19 | 3.58 | 5.23 | 3.30 | 6.33 | 5.91 |
| Cumulative: after 28 d | 92.0 | 75.8 |
| ||||
Mean | 82.8 | |||||||
Cumulative: in mg/L | 61.3 | 50.6 | ||||||
Mean | 55.2 |
Percentage Degradation
| Degradation1 in % | |||||
Time in d | Test item group | Reference control group | Toxicity control group | |||
Replicate 1 | Replicate 2 | Replicate 3 | Replicate 1 | Replicate 2 | Replicate 1 | |
0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 9 | 8 | 13 | 37 | 27 | 27 |
5 | 24 | 36 | 14 | 53 | 44 | 43 |
7 | 30 | 41 | 19 | 63 | 53 | 50 |
9 | 32 | 42 | 25 | 64 | 60 | 54 |
15 | 32 | 42 | 27 | 65 | 72 | 63 |
23 | 41 | 58 | 55 | 65 | 80 | 67 |
28 | 52 | 70 | 68 | 65 | 83 | 67 |
Mean (28 d) | 62 | 74 |
|
After purging carbon dioxide overnight:
29 | 58 | 72 | 69 | 65 | 83 | 68 |
Mean (29 d) | 66 | 74 |
|
1 Corrected for the mean CO2 production of the inoculum control group
Description of key information
IPEMA cannot be considered to be readily biodegradable according to OECD guideline 301 B.
Key value for chemical safety assessment
- Biodegradation in water:
- not biodegradable
- Type of water:
- freshwater
Additional information
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.
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