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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
- Endpoint:
- toxicity to microorganisms, other
- Remarks:
- Toxicity control of ready biodegradability test according to OECD TG 301F
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 July - 27 Aug 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data based on the toxicity control of a ready biodegradability study with the test item. This approach is in accordance with the Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7b: Endpoint specific guidance, ECHA 2017)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 July - 27 Aug 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge: Activated sludge was collected on 29 July 2020 from an aeration tank of a sewage treatment plant treating predominantly domestic sludge in Kurume-shi, Fukuoka, Japan
- Storage conditions: aerated at approximately 22°C until use for the test
- Concentration of sludge: concentration of suspended solids in the collected activated sludge was 2040 mg/L (determined on 29 July 2020) - Duration of test (contact time):
- 28 d
- Initial conc.:
- 30.5 mg/L
- Based on:
- other: test item
- Initial conc.:
- 88 mg/L
- Based on:
- ThOD
- Remarks:
- test item
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: According to the guideline
- Additional substrate: No
- Test temperature: 22±1°C
- pH: 7.3-7.4, measured on day 28 in the test suspension and inoculum blank
- pH adjusted: Yes
- Suspended solids concentration: 30 mg/L
- Continuous darkness: Yes
- Other: In each test vessel, 0.5 g of silica gel was added and stirred for 30 minutes with a stirrer at room temperature. Each test solution was stirred with a stirrer during the incubation period
TEST SYSTEM
- Culturing apparatus: Glass vessels
- Number of culture flasks/concentration: 2 (each containing 9.16 mg test item + 0.5 g silica gel + 4.41 mL inoculum + test media for a total test solution volume of 300 mL)
- Measuring equipment: Closed system oxygen consumption measuring apparatus
- Details of trap for CO2: Soda lime
SAMPLING
- Sampling frequency: BOD of the test solutions was measured continuously during the incubation period with a closed system oxygen consumption measuring apparatus
- Other: appearances of test suspensions and inoculum blank were observed and recorded
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 replicates (each containing 0.5 g silica gel + 4.41 mL inoculum + test media for a total test solution volume of 300 mL)
- Procedure control: 1 replicate (0.5 g silica gel + 30 mg reference substance + 4.41 mL inoculum + test media for a total test solution volume of 300 mL)
- Toxicity control: 1 replicate (9.16 mg test item + 0.5 g silica gel + 30 mg reference substance + 4.41 mL inoculum + test media for a total test solution volume of 300 mL) - Reference substance:
- benzoic acid, sodium salt
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 60
- Sampling time:
- 28 d
- Details on results:
- - The % biodegradation was calculated on the basis of the ThOD of the test item (Pentaerythritol tetrapalmitate, constituting 91.6% of the test material). The test sample was corrected with the purity of the test item. It is noted that the percentage degradation may include biodegradation of the impurity.
- The 28-d biodegradation of the test item was 60% (average). The pass level of biodegradation was not reached within the 10-d window. The 10-d window for the test item started on day 3 (02 Aug 2020) and after 10 days (12 Aug 2020) the biodegradation of the test item was 47% (average).
- 66% biodegradation occurred within 14 days in the toxicity control and therefore the test item was not toxic to microorganisms. - Results with reference substance:
- > 60 % biodegradation of the reference substance occurred within 14 days (90% in 14 d)
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to "Any other information on results incl. tables"
- Interpretation of results:
- inherently biodegradable
- Executive summary:
The biodegradability of Pentaerythritol tetrapalmitate was tested in a GLP study according to OECD TG 301F, where the test material was incubated for 28 days with an inoculum collected from a municipal sewage treatment plant treating predominantly domestic sludge. Silica gel was added to improve the bioavailability of the poorly water soluble test item. The concentration of inoculum in the test vessels was 30 mg suspended solids/L and the concentration of the test item (Pentaerythritol tetrapalmitate) was 30.5 mg/L (88 mg ThOD/L). The degradation of test item was monitored by assessing O2 consumption and the results were calculated by subtracting the amount of BOD in the inoculum blank from the amount of BOD from the test item sample and dividing by the ThOD of the test item (Pentaerythritol tetrapalmitate). A procedure and a toxicity control were run in parallel.
All validity criteria of the TG were fulfilled. In the toxicity control, 66% biodegradation occurred in 14 d and therefore the test item is not toxic to microorganisms.
The 28-d biodegradation of the test item was 60%. This level of biodegradation was not reached within the 10-d window. Therefore, in accordance with Section R.7.9.4.1 of the Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7b: Endpoint specific guidance, ECHA 2017), the test item is considered as inherently biodegradable.
BIOLOGICAL RESULTS:
Table 1: % biodegradation of test item, procedure control and toxicity control
Time (days) | Test item solution 1 | Test item solution 2 | Procedure control | Toxicity control |
7 | 30 | 31 | 83 | 55 |
14 | 49 | 48 | 90 | 66 |
21 | 58 | 54 | 94 | 76 |
28 | 62 | 57 | 96 | 82 |
VALIDITY CRITERIA:
Table 2: Validity criteria for OECD TG 301
Validity 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%. | Difference of extremes 5% | Yes |
Percentage degradation of the reference compound reached the pass level by day 14 (≥ 60%). | 90% in 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. | 66% in 14 d | Yes |
The oxygen uptake of the inoculum blank is normally 20-30 mg O2/L and should not be greater than 60 mg/L in 28 days. | 19-21 mgO2/L in 28 d | Yes |
OTHER OBSERVATIONS:
Table 3: Appearances of test suspension and incolum blank
Test solution | Appearance at the start of incubation | Appearance at the end of incubation |
Test item solution | Test item was not dissolved | The presence or absence of insoluble compound except the sludge could not be confirmed. Growth of sludge was observed |
Inoculum blank | Insoluble compound except the sludge was not observed | Insoluble compound except the sludge was not observed |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Toxicity control of OECD TG 301F (Ready Biodegradability: Manometric Respirometry Test)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2-bis[(hexadecanoyloxy)methyl]propane-1,3-diyl dihexadecanoate
- Cas Number:
- 18641-58-2
- Molecular formula:
- C69H132O8
- IUPAC Name:
- 2,2-bis[(hexadecanoyloxy)methyl]propane-1,3-diyl dihexadecanoate
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test organisms
- Test organisms (species):
- activated sludge of a predominantly domestic sewage
- Details on inoculum:
- - Source of inoculum/activated sludge: Activated sludge was collected on 29 July 2020 from an aeration tank of a sewage treatment plant treating predominantly domestic sludge in Kurume-shi, Fukuoka, Japan
- Storage conditions: aerated at approximately 22°C until use for the test
- Concentration of sludge: concentration of suspended solids in the collected activated sludge was 2040 mg/L (determined on 29 July 2020)
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 14 d
Test conditions
- Test temperature:
- 22±1°C
- pH:
- adjusted to 7.4
- Nominal and measured concentrations:
- Nominal: 30.5 mg test item/L
- Details on test conditions:
- TEST CONDITIONS
- Composition of medium: According to OECD TG 301F
- Test temperature: 22±1°C
- pH: 7.3-7.4, measured on day 28 in the test suspension and inoculum blank
- pH adjusted: Yes
- Suspended solids concentration: 30 mg/L
- Continuous darkness: Yes
- Other: In each test vessel, 0.5 g of silica gel was added and stirred for 30 minutes with a stirrer at room temperature. Each test solution was stirred with a stirrer during the incubation period
TEST SYSTEM (toxicity control)
- Culturing apparatus: Glass vessels
- Number of culture flasks/concentration: 1 (9.16 mg test item + 0.5 g silica gel + 30 mg reference substance + 4.41 mL inoculum + test media for a total test solution volume of 300 mL)
- Measuring equipment: Closed system oxygen consumption measuring apparatus
- Details of trap for CO2: Soda lime
SAMPLING
- Sampling frequency: BOD of the test solutions was measured continuously during the incubation period with a closed system oxygen consumption measuring apparatus
CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 replicates (each containing 0.5 g silica gel + 4.41 mL inoculum + test media for a total test solution volume of 300 mL)
- Procedure control: 1 replicate (0.5 g silica gel + 30 mg reference substance + 4.41 mL inoculum + test media for a total test solution volume of 300 mL) - Reference substance (positive control):
- yes
- Remarks:
- benzoic acid, sodium salt
Results and discussion
Effect concentrations
- Key result
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 30.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: test item
- Basis for effect:
- other: O2 consumption
- Remarks on result:
- other: Result of toxicity control from ready biodegradability test
- Details on results:
- 66% biodegradation occurred within 14 days in the toxicity control (containing 30.5 mg/L of test item and 100 mg/L of reference substance) and therefore the test item was not toxic to microorganisms.
- Results with reference substance (positive control):
- > 60 % biodegradation of the reference substance occurred within 14 days (90% in 14 d)
Any other information on results incl. tables
BIOLOGICAL RESULTS:
Table 1: % biodegradation of test item, procedure control and toxicity control
Time (days) | Test item solution 1 (30.5 mg/L of test item) | Test item solution 2 (30.5 mg/L of test item) | Procedure control (100 mg/L reference substance) | Toxicity control (30.5 mg/L of test item + 100 mg/L reference substance) |
7 | 30 | 31 | 83 | 55 |
14 | 49 | 48 | 90 | 66 |
21 | 58 | 54 | 94 | 76 |
28 | 62 | 57 | 96 | 82 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not applicable
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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