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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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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:
- toxicity to microorganisms, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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).
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Deviations:
- yes
- Remarks:
- 20 °C instead of 22 °C
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
- Deviations:
- yes
- Remarks:
- 20 °C instead of 22 °C
- GLP compliance:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Test substance was added directly to the test bottles. - Test organisms (species):
- activated sludge, domestic
- Details on inoculum:
- - Source of inoculum/activated sludge: Collected from a municipal wastewater treatment plant in Usserød, Denmark.
- Laboratory culture: no
- Pretreatment: The activated sludge was stabilised under continuous aeration for a period of 2 d in order to reduce the content of easily degradable carbon.
- Concentration of sludge: 28.5 mg suspended solids (dry weight)/L - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 14 d
- Test temperature:
- 20°C
- Details on test conditions:
- TEST CONDITIONS
- Composition of medium: according to guideline
- Test temperature: 19.8 ± 0.0 °C
- pH: 7.6 (test start); 7.5 - 7.6 (test end)
- pH adjusted: no
- Suspended solids concentration: 28.5 mg/L (dw)
TEST SYSTEM
- Culturing apparatus: WTW OxiTop® Control System (770 mL test volume)
- Number of culture flasks/concentration: 4
- Measuring equipment: WTW OxiTop® Control System
- Test performed in closed vessels due to significant volatility of test substance: no
SAMPLING
- Sampling frequency: continuously
- Sampling method: The OxiTop® Control system automatically determines the oxygen consumption in the test bottles.
- Sterility check if applicable: no
- Sample storage before analysis: not applicable
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes, 4 bottles
- Abiotic sterile control: no
- Toxicity control: yes, 4 bottles (containing approx. 22 mg/L test item and 20 mg/L of the reference substance)
- Other: Reference substance: yes, 4 bottles - Reference substance (positive control):
- yes
- Remarks:
- sodium benzoate
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Result of toxicity control from ready biodegradability test
- Results with reference substance (positive control):
- The reference substance was degraded to 78 ± 2% of ThOD after 14 d and 85 ± 5% of ThOD after 28 d.
- Endpoint:
- toxicity to microorganisms, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to analogue justification document provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Result of toxicity control from ready biodegradability test
Referenceopen allclose all
The toxicity control attained 70% degradation after 28 days of incubation.
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 22 mg/L can be used as NOEC value for the toxicity to aquatic microorganisms.
The toxicity control attained 70% degradation after 28 days of incubation.
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 22 mg/L can be used as NOEC value for the toxicity to aquatic microorganisms.
Description of key information
14-day NOEC (toxicity control) >= 22 mg/L (OECD 301 F); read-across
Key value for chemical safety assessment
Additional information
Since no studies on the toxicity to aquatic microorganisms are available a ready biodegradability study is used to derive a NOEC for the toxicity to aquatic microorganisms. If a compound degrades well in a ready biodegradability test, or does not inhibit the degradation of a positive control at a certain concentration, this concentration can be used as a NOEC value. This approach is in accordance with the Guidance on information requirements and chemical safety assessment (Chapter R.7b: Endpoint specific guidance, ECHA 2017).
A substance can be assumed to be not inhibitory to aquatic microorganisms, if in the toxicity control of a ready biodegradation test, more than 25% degradation based on oxygen demand (BOD/ThOD) occurred within 14 days (OECD guideline 301). For the source substance Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates a biodegradation test according to OECD guideline 301F is available. The test includes a toxicity control, which contains 22 mg/L of test substance and 20 mg/L of sodium benzoate. The toxicity control attained 81% degradation after 14 days of incubation. Hence, the substance is not toxic to aquatic microorganisms in the toxicity control and the test item concentration of 22 mg/L can be used as NOEC (NOEC (14 d) >= 22 mg/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.
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