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EC number: 308-121-3 | CAS number: 97862-72-1
- 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
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 December 2017 to 06 March 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- non GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Principles of method if other than guideline:
- a preliminary test was performed
- GLP compliance:
- no
- Remarks:
- Quality of the report is similar to that of a report under GLP conditions
Test material
- Reference substance name:
- Fatty acids, C10-30, esters with lanolin alcs.
- EC Number:
- 308-121-3
- EC Name:
- Fatty acids, C10-30, esters with lanolin alcs.
- Cas Number:
- 97862-72-1
- Molecular formula:
- NA
- IUPAC Name:
- Fatty acids, C10-30, esters with lanolin alcs.
- Test material form:
- solid
- Remarks:
- soft solid
Constituent 1
- Specific details on test material used for the study:
- The substance was disolved in dichloromethane
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were transferred to a measuring cylinder to accurately record the volume of each aliquot and then to a separating funnel.
The sample bottle was rinsed with an aliquot of dicholromethane (DCM) and this rinse added to the separating funnel. 50 ml of DCM was then added to each sample and the funnels transferred to a mechanical shaker for 5 minutes. The sample was allowed to settle and the DCM decanted into conical flasks containing sodium sulphate, then drawn off and transferred to a sodium sulphate drying column. The resulting extract was then concentrated to 1 ml and put into vials ready for analysis and stored in the fridge (3.6ºC).
At pH 9 some undissolved particles were present - Buffers:
- - pH: 4
- Composition of buffer: 4ml of 0.1M NaOH + 500ml of 0.1M Potassium phthalate monobasic
- pH: 7
- Composition of buffer: 296.3ml of 0.1M NaOH + 500ml of 0.1M monopotassium phosphate
- pH: 9 - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks: amber bottles with 500mL buffer solution
- Sterilisation method: The buffers are sterilised by filtering to 0.2μm, test was not conducted under sterile conditions
- Measures to exclude oxygen: removed from the bottles by passing nitrogen into the head space prior to sealing
TEST MEDIUM
- Volume used/treatment: 500 mL
- Kind and purity of water: deionised water
- Identity and concentration of co-solvent: dichloromethane (<1% v/v)
0.1012g of the substance was weighed directly into a 100ml volumetric flask and made to volume with DCM to give a sample stock concentration of 10.12 mg/l (pH=7.00). 230µl of sample stock was pipetted into amber bottles containing the different buffer solutions (500ml). A spike was also prepared in 500ml of deionised water.
Duration of testopen allclose all
- Duration:
- 5 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 233 mg/L
- Remarks:
- concentration prepared
- Duration:
- 5 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 233 mg/L
- Remarks:
- concentration prepared
- Duration:
- 5 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 233 mg/L
- Remarks:
- concentration prepared
- Number of replicates:
- not indicated
- Negative controls:
- yes
- Remarks:
- deionised water
- Statistical methods:
- NA
Results and discussion
- Preliminary study:
- Only a pre-test was performed. The substance is not hydrolitically stable at pH 4, 7 and 9 (see tables)
- Transformation products:
- not measured
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- < 5 d
- Remarks on result:
- other: hydrolitically instable based on preliminary test
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- < 5 d
- Remarks on result:
- other: hydrolitically instable based on preliminary test
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- < 5 d
- Remarks on result:
- other: hydrolitically instable based on preliminary test
Any other information on results incl. tables
2.4 Hours |
Retention time (mins) |
Peak area (%) |
Conc (mg/l) |
% Recovery |
pH4 |
13 |
1919 |
41.239 |
17.699 |
pH7 |
13.00 |
5110 |
114.983 |
49.349 |
pH9 |
13.00 |
1963 |
42.256 |
18.136 |
Spike 13.00 |
9872 |
225.033 |
96.581 |
|
5 Days |
Retention time (mins) |
Peak area (%) |
Conc (mg/l) |
% Recovery |
pH4 |
13 |
335 |
4.633 |
1.988 |
pH7 |
13.00 |
1284 |
26.564 |
11.401 |
pH9 |
13.00 |
1251 |
25.802 |
11.074 |
Concentration and Hydrolysis
|
Sample Loading mass (g) |
pH |
% Recovery after 5 days |
Total reaction of substance (%) |
A |
0.1001 |
4 |
1.988 |
98.012 |
B |
0.1001 |
7 |
11.401 |
88.599 |
C |
0.1001 |
9 |
11.074 |
88.926 |
Applicant's summary and conclusion
- Conclusions:
- The substance hydrolyses >10% within 5 days at pH, 4, 7 and 9
- Executive summary:
In a pre-liminary test performed according OECD 111, recoveries of the of the substance solution was low for pH 4 (1.988% of initial), pH 7 (11.401% of initial) and pH 9 (11.401%of initial). Due to the low recoveries it can be asserted that hydrolysis occurred within all of the pH environments and this was rapid (< 50% recovery at 2.4 hours in all pH environments).
As >10% of the substance has been hydrolysed after 5 days, it is considered hydro-statically unstable under the conditions of this test.
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