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EC number: 285-203-4 | CAS number: 85049-34-9
- 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:
- 15 Apr 1997 - 06 Aug 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- GLP Guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)
- Deviations:
- no
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- other: 10% mixed liquor supernatant from Chester Sewage works.
- Details on inoculum:
- - Source of inoculum/activated sludge: Chester Sewage works, United Kingdom
- Laboratory culture: no - Duration of test (contact time):
- 28 d
- Initial conc.:
- 10.06 mg/L
- Based on:
- other: TOC
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- TEST CONDITIONS
- Composition of medium: mineral medium according to OECD Guideline 301B
- Test temperature: 20 °C
- Other: Incubated on a rotary shaker
TEST SYSTEM
- Culturing apparatus: 2.3 L test vessels containing 1500 mL mineral salts medium with inoculum and the respective test or reference substance.
- Number of culture flasks/concentration: 1
- Method used to create aerobic conditions: Filled with CO2-free air
- Measuring equipment: Ionics 555 Inorganic Carbon Analyser
- Test performed in closed vessels due to significant volatility of test substance: Vessels were sealed with a butyl rubber septum and an aluminium crimp seal.
SAMPLING
- Sampling frequency: Sampling was performed on day 3, 7, 10, 14, 17, 21, 24 and 28.
- Sampling method: Vessel was removed and the CO2 in the headspace gas and the concentration of inorganic carbon in the test medium were determined.
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes, 1 vessel
- Abiotic sterile control: no
- Toxicity control: no
- Other: Positive control, 1 vessel - Reference substance:
- benzoic acid, sodium salt
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 79.4
- Sampling time:
- 28 d
- Details on results:
- The test substance was degraded to 79.4% after 28 d and the 10-day time window was reached. Therefore, the test substance is readily biodegradable.
- Results with reference substance:
- 78.1% after 10 d, 60% pass level was reached.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test substance was degraded to 79.4% after 28 d and the 10-day time window was reached. Therefore, the test substance is readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15 Apr 1997 - 06 Aug 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- GLP Guideline study with acceptable restrictions
- Justification for type of information:
- Please refer section 13 for read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)
- Deviations:
- no
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- other: 10% mixed liquor supernatant from Chester Sewage works.
- Details on inoculum:
- - Source of inoculum/activated sludge: Chester Sewage works, United Kingdom
- Laboratory culture: no - Duration of test (contact time):
- 28 d
- Initial conc.:
- 10.06 mg/L
- Based on:
- other: TOC
- Parameter followed for biodegradation estimation:
- CO2 evolution
- Details on study design:
- TEST CONDITIONS
- Composition of medium: mineral medium according to OECD Guideline 301B
- Test temperature: 20 °C
- Other: Incubated on a rotary shaker
TEST SYSTEM
- Culturing apparatus: 2.3 L test vessels containing 1500 mL mineral salts medium with inoculum and the respective test or reference substance.
- Number of culture flasks/concentration: 1
- Method used to create aerobic conditions: Filled with CO2-free air
- Measuring equipment: Ionics 555 Inorganic Carbon Analyser
- Test performed in closed vessels due to significant volatility of test substance: Vessels were sealed with a butyl rubber septum and an aluminium crimp seal.
SAMPLING
- Sampling frequency: Sampling was performed on day 3, 7, 10, 14, 17, 21, 24 and 28.
- Sampling method: Vessel was removed and the CO2 in the headspace gas and the concentration of inorganic carbon in the test medium were determined.
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes, 1 vessel
- Abiotic sterile control: no
- Toxicity control: no
- Other: Positive control, 1 vessel - Reference substance:
- benzoic acid, sodium salt
- Key result
- Parameter:
- % degradation (CO2 evolution)
- Value:
- 79.4
- Sampling time:
- 28 d
- Details on results:
- The test substance was degraded to 79.4% after 28 d and the 10-day time window was reached. Therefore, the test substance is readily biodegradable.
- Results with reference substance:
- 78.1% after 10 d, 60% pass level was reached.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test substance was degraded to 79.4% after 28 d and the 10-day time window was reached. Therefore, the test substance is readily biodegradable.
Referenceopen allclose all
Table 1: % degradation of the test and reference substance over 28 days.
Day |
% Biodegradation |
|
Test substance |
Reference substance |
|
3 |
25.4 |
65.4 |
7 |
56.2 |
73.6 |
10 |
61.4 |
78.1 |
14 |
75.1 |
82.1 |
17 |
79.0 |
82.1 |
21 |
77.9 |
80.6 |
24 |
79.4 |
85.8 |
28 |
79.4 |
83.3 |
Table 1: % degradation of the test and reference substance over 28 days.
Day |
% Biodegradation |
|
Test substance |
Reference substance |
|
3 |
25.4 |
65.4 |
7 |
56.2 |
73.6 |
10 |
61.4 |
78.1 |
14 |
75.1 |
82.1 |
17 |
79.0 |
82.1 |
21 |
77.9 |
80.6 |
24 |
79.4 |
85.8 |
28 |
79.4 |
83.3 |
Description of key information
The test substance is considered to be readily biodegradable: 79.9% after 28 d (OECD 310)
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
- Type of water:
- freshwater
Additional information
Since no studies investigating the ready biodegradability of the test substance are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally related substance 1-methyl-1,2-ethanediyl diisooctadecanoate (CAS 68958-54-3) was conducted. The read-across substance is characterized by the same alcohol component (propylene glycol) diesterified with a longer fatty acid (isostearic acid) and can therefore be used for read-across as a worst case approach since the chain length is the determining factor for biodegradation. The first step of biodegradation is the enzyme-catalysed cleavage of the ester bond by lipase or esterase which are synthesized by a wide range of microorganisms (Boczar et al., 2001). The free fatty acids (C4 to C24 incl. C18 unsatd.) are known to be degraded rapidly and utilized as substrates by activated sludge microorganisms (Kangala & Medrzycka, 2008).
The study for CAS 68958-54-3 was conducted according to OECD 310 (GLP) under aerobic conditions using 10% mixed liquor supernatant from a municipal sewage treatment plant as inoculum and a test substance concentration of approx. 10 mg/L based on TOC (Philpotts, 1997). A mean biodegradation of 79.4% was observed after 28 d. Since the substance reached the pass level (biodegradation is > 60% within the 10-day window) the test substance is stated to be readily biodegradable according to the OECD criteria.
In conclusion, the test substance can be considered to be readily biodegradable based on the result from the suitable read-across substance 1-methyl-1,2-ethanediyl diisooctadecanoate (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5).
References:
Boczar, A.A., Forney, L.J., Begley, W.M., Larson, R.J., Federle, T.W. (2001): Characterization and distribution of esterase activity in activated sludge. Water Research 35(17), 4208-4216.
Kangala, B.C., Medrzycka, K. (2008): Characterization of the fate of lipids in activated sludge. Journal of environmental sciences 20, 536-542.
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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