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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 14, 2022 to August 09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspection :18 to 20 August 2020 Statement : 17 March 2021
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): The sample of inoculum was collected from the secondary effluent of a treatment plant receiving predominantly domestic sewage (Aureilhan, France)
- Laboratory culture: The sample was aerated for about 6 days before use as inoculum at the test temperature to reduce endogenous respiration.
- Concentration of sludge: A concentration of inoculum of 8.3×104 cells/L was used. - Duration of test (contact time):
- 60 d
- Initial conc.:
- 5 mg/L
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Mineral medium, Reconstituted water, as prescribed by OECD Guideline No. 301 (1) (see 2.2.)
- Test temperature: Controlled environment cabinet (22°C ± 2°C); the test was performed in the dark. Measured continuously in the growth chamber.
- pH:
- Suspended solids concentration:
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: All-glass sealed with ground glass stoppers BOD (Biological Oxygen Demand) bottles of approximately 300 mL capacity. Each test vessel was uniquely identified with study code, replicate number, date of the start of the biodegradability test (=J0) and type of series.
- Number of culture flasks/concentration: - 10 bottles containing inoculum, mineral medium and glass coverslip (inoculum blank with solid support)
- 10 bottles containing inoculum and mineral medium (inoculum blank without solid support)
- 10 bottles containing test item, inoculum, mineral medium and glass coverslip (test suspension)
- 6 bottles containing reference substance, inoculum and mineral medium (procedure control)
- 6 bottles containing test item (and glass coverslip), reference substance, inoculum and mineral medium (toxicity control)
- Measuring equipment:
- Test performed in closed vessels due to significant volatility of test substance
Due to the properties of the test item (sticky and viscous substance), the administration of the test item was accomplished by addition onto a solid support and sonication. For this purpose, an appropriate amount of test item was weighed onto a glass coverslip. The test item/support combination was added to the respective test vessels that were filled with 200 mL of mineral medium and closed. Each test vessel was placed in an ultrasonic bath at ambient temperature and sonicated for 40 minutes. Then the vessels were allowed to cool to room temperature before being completely filled with the inoculated mineral medium to obtain a nominal concentration of 5 mg test item/L, and were then closed. The test was carried out without adjustment of the pH.
Determinations of the concentration of dissolved oxygen using an oxygen electrode in duplicate vessels were made on day 0, 7, 14, 21, 28, 35, 42, 49, 56 and 60 for the test suspension and the inoculum blank with solid support, on day 0, 7, 14, 21 and 28 for the inoculum blank without solid support, and only at the start of the test and after 7 and 14 days of incubation for the procedure and toxicity control. Determinations of dissolved oxygen concentration after day 28 were made from reincubated test vessels (used for O2 measurements on previous days). This was made possible by the funnel-shaped bulge in the neck of the test vessels that enabled the oxygen sensor to be submerged without overflowing the sample (i.e. the sample displaced by the sensor was collected in the neck of the test vessel and flowed back into it when the sensor was removed; then the test vessel was closed and reincubated up to a possible additional O2 measurement in the following days). - Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- no
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 41
- Sampling time:
- 60 d
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 29
- Sampling time:
- 28 d
- Details on results:
- In this study, the test item was biodegraded by 29% after 28 days (see Table 3 and Figure 1 of Appendix II). The test period was therefore extended to 60 days in order to improve the biodegradability and persistence assessments. The biodegradation percentage on day 60 was 41%. It should be noted that the test item had no inhibitory effect on the activity of the microbial inoculum, as demonstrated by the test results of the toxicity control, in agreement with OECD 301 (oxygen consumption in the toxicity control must be greater than 25% of the ThOD value within 14 days).
Therefore, ZA3155 BALMYWOOD cannot be considered as readily biodegradable under the experimental conditions, but can be considered as inherently primary (partially) biodegradable.
- Results with reference substance:
- The biodegradation percentage of the reference substance, sodium benzoate, was 76% at day 14, thus confirming the suitability of the inoculum used.
Moreover, in the toxicity control containing both the test item and reference item sodium benzoate, 47% biodegradation was noted at day 14 of the test. According to the test guideline, the test item can be assumed to be not inhibitory to the microbial inoculum because degradation was greater than 25% within 14 days (based on ThOD).
Thus all validity criteria of the test have been fulfilled in the present study - Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- In this study, the test item was biodegraded by 29% after 28 days. The test period was therefore extended to 60 days in order to improve the biodegradability and persistence assessments. The biodegradation percentage on day 60 was 41%. It should be noted that the test item had no inhibitory effect on the activity of the microbial inoculum, as demonstrated by the test results of the toxicity control, in agreement with OECD 301
The test item cannot be considered as readily biodegradable under the experimental conditions, but can be considered as inherently primary (partially) biodegradable. - Executive summary:
The readily biodegradability of the tested substance was assessed according to the OECD Guideline for testing of Chemicals No. 301 D, "Ready biodegradability – Closed Bottle Test", referenced as Method C.4-E of Commission Regulation No. 440/2008 and with ISO 10634, over a period of 60 days. BOD bottles were filled with mineral medium inoculated with a secondary effluent of a treatment plant and test item added at a nominal concentration of 5 mg/L with the help of a solid support (glass coverslip) followed by sonication. In the meantime, two series of blanks (with and without solid support) were filled with inoculated mineral medium. Furthermore, bottles containing reference substance sodium benzoate (5 mg/L) were tested in order to check the procedure. A toxicity control, containing both the test item and the reference substance, was also performed in order to check the absence of test item effect on the microbial inoculum. The concentrations of dissolved oxygen in duplicate bottles from each group incubated at 22°C ± 2°C in darkness were measured at the start of the test and thereafter once a week until the end of the test (except for the procedure and toxicity control, where measurements were made until day 14).
The mean biodegradation of the test item at day 28 was 29% (ThOD), therefore the study was prolonged till day 60. The mean biodegradation at test end after 60 days was 41% (ThOD). Therefore, test item is considered to be not readily biodegradable based on ThOD after 28 days but reached degradation rate of 41% (ThODNH4) after 60 days.
The test item cannot be considered as readily biodegradable under the experimental conditions, but can be considered as inherently primary (partially) biodegradable.
Reference
Table 2. Dissolved oxygen concentrations (mg/L) throughout the test.
| Time (days) | |||||||||
0 | 7 | 14 | 21 | 28 | 35 | 42 | 49 | 56 | 60 | |
Inoculum Blank + solid support | 8.22 | 8.15 | 8.12 | 7.72 | 7.22 | 7.27 | 7.30 | 7.25 | 7.21 | 7.09 |
8.34 | 8.12 | 8.07 | 7.56 | 7.46 | 7.34 | 7.28 | 7.13 | 7.00 | 7.24 | |
Mean | 8.28 | 8.14 | 8.10 | 7.64 | 7.34 | 7.31 | 7.29 | 7.19 | 7.11 | 7.17 |
Test Suspension (5 mg test item/L) | 8.07 | 5.34 | 4.90 | 3.52 | 2.69 | 1.56 | 0.89 | 0.86 | 0.72 | 0.62 |
7.88 | 5.56 | 5.10 | 3.68 | 2.62 | 1.62 | 0.93 | 0.59 | 0.99 | 1.04 | |
Mean | 7.98 | 5.45 | 5.00 | 3.60 | 2.66 | 1.59 | 0.91 | 0.73 | 0.86 | 0.83 |
Inoculum Blank (without solid support) | 8.18 | 8.09 | 7.98 | 7.69 | 7.43 | - | - | - | - | - |
8.18 | 8.15 | 8.04 | 7.73 | 7.44 | - | - | - | - | - | |
Mean | 8.18 | 8.12 | 8.01 | 7.71 | 7.44 | - | - | - | - | - |
Procedure Control (5 mg reference substance/L) | 8.20 | 1.55 | 1.09 | - | - | - | - | - | - | - |
8.20 | 1.80 | 1.16 | - | - | - | - | - | - | - | |
Mean | 8.20 | 1.68 | 1.13 | - | - | - | - | - | - | - |
Toxicity Control (5 mg reference substance/L + 5 mg test item/L) | 8.06 | 5.39 | 3.71 | - | - | - | - | - | - | - |
7.92 | 5.36 | 4.05 | - | - | - | - | - | - | - | |
Mean | 7.99 | 5.38 | 3.88 | - | - | - | - | - | - | - |
| Time (days) | ||||||||||
0 | 7 | 14 | 21 | 28 | 35 | 42 | 49 | 56 | 60 | ||
Test Suspension (5 mg test item/L) | Replicate 1 | 0.00 | 17.65 | 20.38 | 26.69 | 30.31 | 37.78 | 42.25 | 41.77 | 42.15 | 43.24 |
Replicate 2 | 0.00 | 14.85 | 17.71 | 24.30 | 29.49 | 36.08 | 40.68 | 42.32 | 39.01 | 39.08 | |
Mean | 0 | 16 | 19 | 25 | 30 | 37 | 41 | 42 | 41 | 41 | |
Procedure Control (5mg reference substance/L) | Replicate 1 | 0.00 | 78.92 | 83.11 | - | - | - | - | - | - | - |
Replicate 2 | 0.00 | 75.93 | 82.28 | - | - | - | - | - | - | - | |
Mean | 0 | 77 | 83 | - | - | - | - | - | - | - | |
Toxicity Control (5 mg reference substance/L + 5 mg test item/L) | Mean | 0 | 30 | 47 | - | - | - | - | - | - | - |
| Values for | Validity criteria for the test |
Oxygen depletion in the Control after 28 days | < 1.5 mg/L | OK (Control: 1.13 mg/L) (Solid support Control 0.75 mg/L) |
Dissolved Oxygen in the bottles (test item) during the study | ≥ 0.5 mg/L | OK (0.62 to 1.04 mg/L) |
Variation between test item replicates at the end of the test | < 20% | OK (Cv =7%) |
Biodegradadability of the reference item within 14 days | ≥ 60% | OK (83% Day 14) |
Biodegradadability of the toxicity control at 14 days | ≥ 25% (ThOD) | OK (47%) |
Description of key information
OECD Guideline 301D, GLP, key study, validity 1:
29% after 28 days, 41% after 60 days.
The test item cannot be considered as readily biodegradable under the experimental conditions, but can be considered as inherently primary (partially) biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- not biodegradable
- Type of water:
- freshwater
Additional information
The readily biodegradability of the tested substance was assessed according to the OECD Guideline for testing of Chemicals No. 301 D, "Ready biodegradability – Closed Bottle Test", referenced as Method C.4-E of Commission Regulation No. 440/2008 and with ISO 10634, over a period of 60 days. BOD bottles were filled with mineral medium inoculated with a secondary effluent of a treatment plant and test item added at a nominal concentration of 5 mg/L with the help of a solid support (glass coverslip) followed by sonication. In the meantime, two series of blanks (with and without solid support) were filled with inoculated mineral medium. Furthermore, bottles containing reference substance sodium benzoate (5 mg/L) were tested in order to check the procedure. A toxicity control, containing both the test item and the reference substance, was also performed in order to check the absence of test item effect on the microbial inoculum. The concentrations of dissolved oxygen in duplicate bottles from each group incubated at 22°C ± 2°C in darkness were measured at the start of the test and thereafter once a week until the end of the test (except for the procedure and toxicity control, where measurements were made until day 14).
The mean biodegradation of the test item at day 28 was 29% (ThOD), therefore the study was prolonged till day 60. The mean biodegradation at test end after 60 days was 41% (ThOD). Therefore, test item is considered to be not readily biodegradable based on ThOD after 28 days but reached degradation rate of 41% (ThODNH4) after 60 days.
The test item cannot be considered as readily biodegradable under the experimental conditions, but can be considered as inherently primary (partially) 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.