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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_environmental-fate-and-pathways.png)
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:
- 09 Oct - 20 Oct 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- other: ISO standard 10634
- Version / remarks:
- 1995
- Principles of method if other than guideline:
- Recorded deviations
• On nominal day 2 it was noticed that the ingoing aeration line was disconnected and there was a temporary breakdown in aeration for test item bottle B, the toxicity control, and blank bottle B.
Evaluation: This relatively short breakdown (<1 day) in aeration is normally considered to have no effect on the outcome of the study. Furthermore, the results for bottle B are in good agreement with bottle A for both the test item as well as the blanks while the toxicity control has satisfied the 25% biodegradation validity criterion.
• Between nominal day 17 and 18 a temporary breakdown in aeration (<1 day) occurred. This was observed in all vessels. The gas cylinders were empty.
Evaluation: Such a short breakdown in aeration does not influence the outcome or validity of the study. - GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, vegetable-oil, polymd., esters with 1,2-hexadecanediol
- Cas Number:
- 68910-99-6
- Molecular formula:
- Not applicable (i.e., UVCB substance)
- IUPAC Name:
- Fatty acids, vegetable-oil, polymd., esters with 1,2-hexadecanediol
- Test material form:
- other: paste
Constituent 1
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): activated sludge obtained from a municipal sewage treatment plant: 'Waterschap Aa en Maas', 's-Hertogenbosch, The Netherlands, receiving predominantly domestic sewage.
- Pretreatment: The freshly obtained sludge was kept under continuous aeration until further treatment. Before use, the sludge was allowed to settle (30 min) and the supernatant liquid was used as inoculum.
- Concentration of sludge: 10 mL/L of mineral medium
- Initial cell/biomass concentration: 4.13 g/L suspended solids - Duration of test (contact time):
- 28 d
Initial test substance concentrationopen allclose all
- Initial conc.:
- 15.5 mg/L
- Based on:
- test mat.
- Initial conc.:
- 12 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: The day before the start of the test (day -1) mineral components, Milli- RO water (ca. 80% of final volume) and inoculum (1% of final volume) were added to each bottle. This mixture was aerated with synthetic air overnight to purge the system of CO2.
- Test temperature: 22.2 - 23.5 °C
- pH: 7.7 - 7.6
- Continuous darkness: yes
TEST SYSTEM
- Number of culture flasks/concentration: 2 (2 litre brown coloured glass bottles)
- Method used to create aerobic conditions: A mixture of oxygen (ca. 20%) and nitrogen (ca. 80%) was passed through a bottle containing 0.5 - 1 litre 0.0125 M Ba(OH)2 solution to trap CO2
- Details of trap for CO2 and volatile organics if used: (bottles filled with 100 mL 0.0125 M Ba(OH)2
SAMPLING
- Sampling method: Titrations were made every second or third day during the first 10 days, and thereafter at least every fifth day until day 28, for the inoculum blank and test item. Titrations for the positive and toxicity control were made over a period of at least 14 days.
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 replicates
- Positive control: 1 replicate
- Toxicity control: 1 replicate
Reference substance
- Reference substance:
- acetic acid, sodium salt
Results and discussion
% Degradation
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 0
- Sampling time:
- 28 d
- Details on results:
- In the toxicity control, more than 25% biodegradation occurred within 14 days (44% based on ThCO2). Therefore, the test item was assumed not to inhibit microbial activity.
Any other information on results incl. tables
Table 1: Validity criteria for OECD 301.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
Difference of extremes of replicate values of the removal of the test chemical at the plateau, at the end of the test or at the end of the 10-d window, as appropriate, is less than 20%. |
≤ 0% |
yes |
Percentage degradation of the reference compound has reached the pass levels by day 14. |
83% after 14 d |
yes |
The toxicity control should degrade to at least 35% (based on DOC) or at least 25% (based on ThOD or ThCO2) within 14 d. |
44% at day 15 |
yes |
The IC content of the test substance suspension in the mineral medium at the beginning of the test must be less than 5% of the TC. |
<5% |
yes |
The total CO2 evolution in the inoculum blank at the end of the test should not normally exceed 40 mg/L medium. |
56.2 mg CO2per 2 litres of medium |
yes |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
- Interpretation of results:
- under test conditions no biodegradation observed
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)