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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification document provided in IUCLID section 13.
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: BOD
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other: Biodegradation toxicity control
- Remarks:
- source, RA-A, CAS 91050-80-5, Emery, 2007, BODIS Test
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Jun - 10 Jul 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data based on the inhibition control of a ready biodegradability study. This approach is in accordance with the Guidance on information requirements and chemical safety assessment (Chapter R.7b: Endpoint specific guidance, ECHA 2012).
- Qualifier:
- according to guideline
- Guideline:
- other: Toxicity control from MARINE BODIS ISO/TC 147/SC 5/WG 4N 141
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Toxicity control from ISO 10708
- Principles of method if other than guideline:
- Unlike similar screening tests for biodegradability in freshwater systems, thismethod uses natural seawater fortified with mineral nutrients and no innoculum is added in addition to the micro-organisms already present in the seawater. Results from this test are not to be taken as indicators for ready or ultimate biodegradability but serves only to provide a preliminary level of information on ready degradability in seawater.
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Details on test solutions:
- The test vessels are closed glass bottles with a known volume of aqueous test mixture (66.6%) and air (33.3%). They are shaken continuously to assure steady state oxygen partitioning between the aqueous and gaseous phase. The degradation is followed by weekly measurements of the BOD in the aqueous phase for a minimum 28 day period. The test vessels are re-aerated and resealed after measurement. The total oxygen uptake in the test flasks is calculated from the measured dissolved oxygen concentration divided by the saturation value at normal conditions and multiplied with the total oxygen content originally present in the aqueous and gaseous phases.
- Test organisms (species):
- other: natural seawater
- Details on inoculum:
- Unlike similar screening tests for biodegradability in freshwater systems, this method uses natural seawater fortified with mineral nutrients and no innoculum is added in addition to the micro-organisms already present in the seawater. The raw seawater used for this study was supplied by a submersible pump situated on Sutherland’s pier on the west side of Flotta in Scapa Flow. It is pumped continuously from a depth of two metres below low water spring tide level, before passing up 1.8 kilometres of plastic pipe to a 20,000 litre storage tank. Two smaller pumps move the water to three settlement tanks situated nine metres above floor level. The seawater temperature varies between 6º C in the winter and 14º C in the summer. The salinity is between 34‰ and 37‰. Five to seven days before test commencement, raw seawater passes by gravity through a 45 µm filter to the ageing tank. Collected on 06 June 2007.
- Test type:
- static
- Water media type:
- saltwater
- Total exposure duration:
- 28 d
- Nominal and measured concentrations:
- Initial test substance concentration: 20 mg/L based on BOD
- Details on test conditions:
- TEST CONDITIONS
- Composition of medium: Natural seawater enriched with (in g/L):
KH2PO4: 8.5
K2HPO4: 21.7
Na2HPO4 x 2H2O: 29.92
NH4Cl: 0.5
CaCl2: 31.84
MgSO4 x 7H2O: 22.5
FeCl3 x 6H2O: 0.25
EDTA: 0.4
- Solubilising agent (type and concentration if used): In tests conducted with poorly soluble materials, an inert support medium is used to provide a large and controlled surface area: 1 g/bottle of chromatography silica powder containing 20 mg of ThOD/g test material/reference base fluid
- Test temperature: 19.3 - 20.2 °C
- Aeration of dilution water: yes; Saturation value for dissolved oxygen at normal atmospheric pressure: 7.45 mg/L; Total Oxygen Capacity: 26.64 mg Oxygen per test vessel
TEST SYSTEM
- Culturing apparatus: 270 (± 0.5) mL glass BOD bottles containing 180 mL test medium
- Number of culture flasks/concentration: 3
- Measuring equipment: Polarographic electrode
- Test performed in closed vessels due to significant volatility of test substance: yes
CONTROL AND BLANK SYSTEM
- Inoculum blank: 3 replicates
- Toxicity control: 3 replicates
- Other: support medium blank: 3 replicates - Reference substance (positive control):
- yes
- Remarks:
- benzoic acid, sodium salt
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: BOD
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Remarks on result:
- other: Biodegradation toxicity control
- Details on results:
- The test item biodegraded by 94% over 28 days and showed an inhibition of -7% to seawater bacteria. The Oxygen blank and reference oil degradation were within formal and informal limits of acceptability, respectively.
- Results with reference substance (positive control):
- The soluble reference material, sodium benzoate, degraded by more than 60% in the first fourteen days, indicating that the seawater used in the test contained a satisfactory population of viable bacteria.
Referenceopen allclose all
The toxicity control attained > 35% degradation after 14 days (73% after 14 d) of incubation.
"If in a toxicity test, containing both the test and the reference substance, less than 35% based on total DOC or less than 25% based on total ThOD or ThCO2 occurred within 14 days, the test substance can be assumed to be inhibitory." (OECD Guideline 301)
Since more than 25% degradation occurred in the toxicity control, the substance is with high probability not toxic to aquatic microorganisms.The test item concentration in the toxicity control of 20 mg/L BOD can be used as NOEC value for the toxicity to aquatic microorganisms.
Description of key information
NOEC (14 d) ≥ 20 mg/L BOD (natural seawater, ISO 10708, toxicity control)
Key value for chemical safety assessment
Additional information
There is no study available in which the toxicity of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers to microorganisms was assessed. Therefore, read-across to the structurally and chemically related source substance Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5) was performed in accordance with Regulation (EC) No 1907/2006 Annex XI, section 1.5 in order to fulfill the data requirements for this substance. The source substance is characterized by similar chemical structure and is therefore considered as suitable representative for the assessment of the toxicity of the target substance to microorganism.A detailed read-across justification in provided in IUCLID section 13.
The toxicity of the source substance Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5) to microorganisms was investigated in a biodegradation study similar to ISO 10708 under GLP conditions. The study was performed with natural seawater as inoculum. A toxicity control included in the biodegradation study with a test item concentration of 20 mg/L BOD reached biodegradation > 35% within 14 days (76% after 14 d). Thus, the test substance is not inhibitory to aquatic microorganisms. According to ECHA Guidance R.7b (ECHA, 2017) the test item concentration can be used as NOEC value for the toxicity to aquatic microorganisms. Thus, a NOEC (14 d) of ≥ 20 mg/L BOD resulted.
Based on the available results in a biodegradation study from a structurally related read-across substance (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that the target substance Fatty acids, C16-18 (even numbered), esters with glycerol oligomers is not expected to show toxicity to microorganisms up to the limit of its water solubility (91.9 µg/L).
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.