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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
- Experiment start date - 04 December 2020; Experiment completion date - 09 January 2021; Study completion date - 29 April 2021.
- 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:
- Test Item: FAT 75637/B
Physical Appearance: Light yellow powder
Purity: 99.4 % all organic constituents; 95.0 % main constituent
Batch No: AT-0063765400
Manufactured Date: 21st April 2020
Expiry Date: May 27th, 2025 - Oxygen conditions:
- aerobic
- Inoculum or test system:
- sewage, domestic (adaptation not specified)
- Details on inoculum:
- The inoculum was secondary effluent, sourced from a treatment plant receiving predominantly domestic sewage. This effluent was used as test system as it is recommended in the guideline. A fresh sample of secondary effluent was collected from the treatment plant and was kept aerobic during transport. This effluent was allowed to settle for one hour, decanted and the decanted effluent was used in the test.
- Duration of test (contact time):
- 28 d
- Initial conc.:
- 22 mg/L
- Based on:
- act. ingr.
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- TEST CONDITIONS
- Composition of medium:
Stock Solution Chemical Quantity (g)
A Potassium dihydrogen orthophosphate, KH2PO4 (AR) 4.2512
Dipotassium hydrogen orthophosphate, K2HPO4 (AR) 10.8734
Disodium hydrogen orthophosphate dihydrate, Na2HPO4.2H2O (AR) 16.7072
Ammonium chloride, NH4Cl (AR) 0.2502
These four constituents were dissolved in and made up to 500 mL using Milli-Q water. The pH of the solution was 7.51.
B Calcium chloride, dihydrate, CaCb.2H2O (AR) 18.2013
This was dissolved in and made up to 500 mL using Milli-Q water.
C Magnesium sulphate heptahydrate, MgSO4.7H2O (ExcelaR) 11.2510
This was dissolved in and made up to 500 mL using Milli-Q water.
D Iron (III) chloride hexahydrate, FeCb.6H2O (AR) 0.1251
This was dissolved in and made up to 500 mL using Milli-Q water.
The test medium for test flasks 1 to 6, was prepared by mixing 24 mL of stock solution A with 1920 mL of Milli-Q water, then 2.4 mL each of stock solutions B, C and D was added and finally the volume was made up to 2400 mL using Milli-Q water in each flask. Similarly, for Flask 7, 3000 mL of test medium was prepared by mixing 30 mL of stock solution A with 2400 mL of Milli-Q water, then 3 mL each of stock solutions B, C and D was added and finally the volume was made up to 3000 mL with Milli-Q water.
- Test temperature: 22.4 to 23.6 ºC
- pH: 7.51 to 7.55
- Aeration of dilution water: Yes
- Continuous darkness: yes
TEST SYSTEM
To each 5 L flask, 2400 mL of mineral medium was added and mixed with 300 mL of the pre-conditioned inoculum. A separate 3000 mL of mineral medium was also prepared in a flask to use it for further dilutions. A sample of the mineral medium was checked for the inorganic carbon content. These flasks were aerated with CO2 free air at 100 mL/minute, overnight to purge the system of carbon dioxide.
CONTROL AND BLANK SYSTEM
- Inoculum blank: Yes
- Toxicity control: Yes - Reference substance:
- benzoic acid, sodium salt
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 17.06
- Sampling time:
- 28 d
- Results with reference substance:
- The percent degradation of reference item was 92.51 % and the toxicity control was 43.88 % at the end of the test.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- Based on the results, the test item was concluded as non-biodegradable since only 17.06 % mean degradation was achieved within the 28-day period of the test.
- Executive summary:
The ready biodegradability of FAT 75637/B was tested using the CO2 Evolution Test. This study was conducted according to OECD test guideline 301C in a GLP-certified laboratory. The test item was added to two test vessels at the concentration of 22.0 mg/L (equivalent to 15.6 mg of Total Organic Carbon/L). Two flasks as controls containing only the inoculum, one flask as procedure control containing reference item and one flask as toxicity control containing the test item and the reference item were included in the test. All the treatments were added with equal volume of inoculum which was collected from the secondary effluent treatment plant receiving predominantly domestic sewage and volume made with mineral media. Treatment mixtures were aerated for 29 days with carbon dioxide (CO2) free air. The CO2 released was trapped in a series of bottles containing barium hydroxide, which were connected to the outlet of each test vessel. The residual barium hydroxide was measured on days 2, 4, 7, 9, 12, 14, 18, 22, 26 and 29 after the initiation of the test. The mean percent degradation of test item was 17.06 % at the end of test while, the percent degradation of reference item was 92.51 % and the toxicity control was 43.88 % at the end of the test. The test fulfilled all the validity criteria. Based on the results, the test item was concluded as non-biodegradable since only 17.06 % mean degradation was achieved within the 28-day period of the test.
Reference
Test Item Solubility: The test item formed a suspended particle and found settled at bottom in mineral medium at 220 mg/L.
Bacterial Population in the Inoculum: The bacterial population in the inoculum was 7.0 x 10E7 CFU/L.
Degradation of Test Item and Reference Item
Day |
Degradation (%) |
||||
Test Item |
Reference Item |
Test Item+ Reference Item |
|||
Flask 1 |
Flask 2 |
Mean |
|||
2 |
0.80 |
0.29 |
0.55 |
16.53 |
17.42 |
4 |
1.60 |
1.21 |
1.41 |
27.99 |
13.55 |
7 |
8.00 |
7.94 |
7.97 |
43.70 |
19.13 |
9 |
10.85 |
11.81 |
11.33 |
59.44 |
29.74 |
12 |
11.49 |
15.65 |
13.57 |
58.52 |
23.90 |
14 |
11.49 |
15.20 |
13.35 |
72.33 |
31.68 |
18 |
12.70 |
16 .93 |
14.82 |
85.60 |
37.00 |
22 |
14.43 |
18.72 |
16.58 |
90.60 |
40.90 |
26 |
15.39 |
18.72 |
17.06 |
92.51 |
43.88 |
29 |
15.39 |
18.72 |
17.06 |
92.51 |
43.88 |
Description of key information
FAT 75637/B was concluded as non-biodegradable since only 17.06 % mean degradation was achieved within the 28-day period of the test.
Key value for chemical safety assessment
- Biodegradation in water:
- not biodegradable
- Type of water:
- freshwater
Additional information
The ready biodegradability of FAT 75637/B was tested using the CO2 Evolution Test. This study was conducted according to OECD test guideline 301C in a GLP-certified laboratory. The test item was added to two test vessels at the concentration of 22.0 mg/L (equivalent to 15.6 mg of Total Organic Carbon/L). Two flasks as controls containing only the inoculum, one flask as procedure control containing reference item and one flask as toxicity control containing the test item and the reference item were included in the test. All the treatments were added with equal volume of inoculum which was collected from the secondary effluent treatment plant receiving predominantly domestic sewage and volume made with mineral media. Treatment mixtures were aerated for 29 days with carbon dioxide (CO2) free air. The CO2 released was trapped in a series of bottles containing barium hydroxide, which were connected to the outlet of each test vessel. The residual barium hydroxide was measured on days 2, 4, 7, 9, 12, 14, 18, 22, 26 and 29 after the initiation of the test. The mean percent degradation of test item was 17.06 % at the end of test while, the percent degradation of reference item was 92.51 % and the toxicity control was 43.88 % at the end of the test. The test fulfilled all the validity criteria. Based on the results, the test item was concluded as non-biodegradable since only 17.06 % mean degradation was achieved within the 28-day period of the test.
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.