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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 948-071-5 | 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:
- 21 August 2017 to ****
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Purity: >98%; Unknown or Variable composition, is a Complex reaction product, or a Biological material (UVCB)
- Description: Yellow Liquid
- Carbon Content: 54.4% - Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- A sample of activated sludge was collected from one of the return lines at Burley Menston sewage treatment works (West Yorkshire, UK), which has a predominantly domestic waste-water catchment. The sample was aerated using a compressed air supply. The suspended solids concentration of the activated sludge was determined to be 5.06 g/L. The activated sludge used in this study was not acclimatised or adapted to the test substance prior to exposure under the test conditions.
- Duration of test (contact time):
- 28 d
- Initial conc.:
- 15 other: mg C/L
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Buffered synthetic, mineral salts medium prepared according to OECD guideline 301B
- Additional substrate: None.
- Solubilising agent (type and concentration if used): None.
- Test temperature: 22 ± 2°C
- pH: Measurements of pH were made in the blank control and reference substance vessels at the start of incubation and in all vessels at the end of the test prior to the addition of the hydrochloric acid.
- pH adjusted: No.
- Aeration of dilution water: Yes.
- Suspended solids concentration: The concentration of suspended solids was calculated to be 5.06 g/L. The medium was inoculated with activated sludge to give a suspended solids concentration of 30 mg/L in each control or test vessel.
- Continuous darkness: Yes.
TEST SYSTEM
- Number of culture flasks/concentration: Test substance vessels were prepared in duplicate (15 mg C/L).
- Method used to create aerobic conditions: Continuously sparged with a supply of CO2 free air (ca. 50 mL per minute).
- Measuring equipment: Titration (see details on analytical methods).
- Details of trap for CO2 and volatile organics if used: The exhaust air from each vessel was passed through a series of three traps containing a barium hydroxide solution.
SAMPLING
- Sampling frequency: Days 2, 5, 7, 8, 12, 16, 19, 23, 26, 28 and on Day 29 (following acidification and overnight aeration).
- Sampling method: Traps were removed from the series and their contents titrated with hydrochloric acid to determine the quantity of CO2 evolved from the respective test vessels. At the end of incubation, 28 days, the test vessel contents were acidified to release any residual CO2 that may have remained in solution. Titration of the remaining traps on Day 29 was performed following overnight aeration.
- Sterility check if applicable: Not applicable.
- Sample storage before analysis: Not applicable.
CONTROL AND BLANK SYSTEM
- Inoculum blank: Two blank control vessels containing inoculated medium only were prepared to assess the validity of the test and to correct for baseline CO2 evolved.
- Procedure control: Two procedure control vessels containing a reference substance, sodium benzoate (15 mg C/L), were prepared to assess the performance of the inoculum.
- Toxicity control: An additional vessel containing a combination of the test and reference substances (15 mg C/L) served as a toxicity control to assess whether the test substance was inhibitory to biodegradation at the test concentration.
- Abiotic sterile control: Not applicable.
STATISTICAL METHODS
Not applicable. - Reference substance:
- benzoic acid, sodium salt
- Remarks:
- 15 mg C/L
- Preliminary study:
- A solubility trial was performed by adding the test substance to reverse osmosis (RO) water. After 5 minutes sonication and 5 minutes stirring, the test substance appeared to have gone in solution. The test substance was therefore deemed sufficiently soluble to be added as an aqueous stock solution and the test substancewas therefore added to the test vessels as an aqueous stock solution.
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 9
- Sampling time:
- 28 d
- Details on results:
- Measured pH values ranged from 7.42 to 7.51 on Day 0 and 7.53 to 7.71 on Day 28.
The mean total CO2 production in the blank control vessels was 33.1 mg/L at the end of the test, satisfying the validity criterion of < 70 mg/L.
Carbon dioxide evolution in the test substance vessels did not exceed 12% over the exposure period. Mean percent biodegradation of the test substance reached only 9% after 28 days. The test substance therefore cannot be considered readily biodegradable. Percent biodegradation values at each sampling interval, for the two replicates containing the test substance did not vary by more than 15%, satisfying the validity criterion of less than 20% difference. - Results with reference substance:
- Biodegradation of the reference substance vessels exceeded 60% by Day 7 (68%), 89% by the end of the incubation phase on Day 28 and 89% at the end of the test on Day 29. Biodegradation of the reference substance in the presence of the test substance in the toxicity control (73% at Day 7, 93% by the end of the incubation phase on Day 28 and 94% by the end of the test on Day 29) was similar to that of the reference substance alone, indicating that the test substance did not have an inhibitory effect on the inoculum under the test conditions, and satisfying the validity criterion.
- Validity criteria fulfilled:
- yes
- Remarks:
- Exception: The inorganic carbon (IC) content of the test medium was 3.81 mg C/L (or, 8.47%). There was no indication of suppression from increased IC content based on toxicity control and inoculum blanks. The results were therefore considered valid.
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The mean percent biodegradation of the test substance reached only 9% after 28 days. The test substance cannot, therefore, be considered readily biodegradable under the strict terms and conditions of OECD Guideline No. 301B.
- Executive summary:
The ready biodegradability of the test substance was assessed by measurement of carbon dioxide (CO2) evolution under standard conditions according to OECD Test Guideline 301B., under GLP conditions. The test substance was administered to the test system as an aqueous stock solution. A buffered synthetic, mineral salts medium prepared according to OECD guideline 301B was added to give a test substance concentration equivalent to 15 mg C/L. The concentration of suspended solids was calculated to be5.06g/L. The medium was inoculated from a sample of non-adapted activated sludge to give a suspended solids concentration of 30 mg/L in each control or test vessel. Test vessels were incubated in darkness at 22 ± 2°C for 28 days and their contents continuously sparged with a supply of CO2 free air (ca. 50 mL per minute). The exhaust air from each vessel was passed through a series of traps containing a barium hydroxide solution to trap evolved CO2.
On Days 2, 5, 7, 8, 12, 16, 19, 23, 26, 28, traps were removed from the series and their contents titrated with hydrochloric acid to determine the quantity of CO2 evolved from the respective test vessels. At the end of incubation, 28 days, the test vessel contents were acidified to release any residual CO2 that may have remained in solution. Titration of the remaining traps on Day 29 was performed following overnight aeration. Measurements of pH were made in the blank control and reference substance vessels at the start of incubation and in all vessels at the end of the test prior to the addition of the hydrochloric acid.
The performance of the inoculum was checked by measuring the CO2 evolved from procedure control vessels containing a reference substance, sodium benzoate (15 mg C/L). An additional vessel containing a combination of the test and reference substances (15 mg C/L) served as a toxicity control to assess whether the test substance was inhibitory to biodegradation at the test concentration. Two blank control vessels were also prepared containing inoculated medium only to check the validity of the test and to correct for baseline CO2 evolved. Duplicate vessels were prepared for the test substance, reference substance and blank control groups. A single vessel was prepared for the toxicity control. The mean total CO2 production in the blank control vessels was 33.1mg/L at the end of the test, satisfying the validity criterion of < 70 mg/L.
Biodegradation of the reference substance vessels exceeded 60% by Day 7 (68%), 89% by the end of the incubation phase on Day 28 and 89% at the end of the test on Day 29. Biodegradation of the reference substance in the presence of the test substance in the toxicity control (73% at Day 7, 93% by the end of the incubation phase on Day 28 and 94% by the end of the test on Day 29) was similar to that of the reference substance alone, indicating that the test substance did not have an inhibitory effect on the inoculum under the test conditions, and satisfying the validity criterion.
The mean percent biodegradation of the test substance reached only 9% after 28 days. The test substance therefore cannot be considered readily biodegradable. Percent biodegradation values at each sampling interval, for the two replicates containing the test substance did not vary by more than 15%, satisfying the validity criterion of less than 20% difference.
Reference
Biodegradation as a Percentage of Theoretical CO2 Yield
|
Day 2 |
Day 5 |
Day 7 |
Day 8 |
Day 12 |
Day 16 |
Day 19 |
Day 23 |
Day 26 |
Day 28 |
Day 29# |
||
Reference Substance R1 |
30 |
56 |
65 |
68 |
73 |
78 |
81 |
84 |
86 |
87 |
87 |
87 |
87 |
Reference Substance R2 |
33 |
62 |
71 |
74 |
80 |
85 |
89 |
91 |
91 |
91 |
91 |
91 |
91 |
Mean |
31 |
59 |
68 |
71 |
77 |
82 |
85 |
88 |
89 |
89 |
89 |
89 |
89 |
Test Substance R1 |
0 |
5 |
3 |
1 |
2 |
1 |
1 |
2 |
2 |
3 |
3 |
4 |
5 |
Test Substance R2 |
0 |
6 |
5 |
5 |
6 |
6 |
7 |
8 |
10 |
11 |
10 |
11 |
12 |
Mean |
0 |
6 |
4 |
3 |
4 |
3 |
4 |
5 |
6 |
7 |
7 |
8 |
9 |
Toxicity Control* |
28 |
57 |
73 |
78 |
81 |
85 |
88 |
91 |
93 |
93 |
94 |
94 |
94 |
* Toxicity control values are corrected for mean test substance degradation.
# Day 29 refers to the day that titrations of trap content from acidified vessels were performed. Actual acidification was performed on Day 28.
Description of key information
The ready biodegradability of the test substance was assessed by measurement of carbon dioxide (CO2) evolution under standard conditions according to OECD Test Guideline 301B., under GLP conditions. The mean percent biodegradation of the test substance reached only 9% after 28 days. The test substance cannot, therefore, be considered readily biodegradable under the strict terms and conditions of OECD Guideline No. 301B (Smithers Viscient (ESG) Ltd., 2018).
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
- 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.