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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-305-4 | CAS number: 137-66-6
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-04-08 until 2015-08-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 6-O-palmitoylascorbic acid
- EC Number:
- 205-305-4
- EC Name:
- 6-O-palmitoylascorbic acid
- Cas Number:
- 137-66-6
- Molecular formula:
- C22H38O7
- IUPAC Name:
- 6-O-palmitoylascorbic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Remarks:
- HPLC/UV
- Details on sampling:
- Samples were taken from the control and 100% v/v saturated solution test group from the bulk test preparation at 0 hours and from the pooled replicates at 48 hours.
Samples were stored frozen prior to analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION OF TEST SOLUTIONS
In view of the difficulties associated with the evaluation of aquatic toxicity of poorly water soluble test items, a modification of the standard method for the preparation of aqueous media was performed. An approach endorsed by several important regulatory authorities in the EU and elsewhere (ECETOC, 1996 and OECD, 2000; for references see original study report), is to expose organisms to a saturated solution of the test item in cases where the test item is of high purity and is poorly soluble in water and in the permitted auxiliary solvents and surfactants. Using this approach, a saturated solution was prepared by stirring an excess (50 mg/L) of test item in culture medium for a period of 24 hours prior to removing any undissolved test item present by filtration (0.2 µm Sartorius Sartopore, first approximate 1 liter discarded in order to pre-condition the filter) to give a saturated solution of the test item.
Range-finding test concentrations were 0.10, 1.0, 10 and 100% v/v saturated solution.
Based on the results of the range-finding test a "limit test" was conducted at a concentration of 100% v/v saturated solution.
A nominal amount of test item (550 mg) was dispersed in 11 liters of test water with the aid of propeller stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and any undissolved test item was removed by filtration through a 0.2 µm Sartorius Sartopore filter (first approximate 1 liter discarded in order to pre-condition the filter) to give the required test concentration of 100% v/v saturated solution.
The prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- The test was carried out using 1st instar Daphnia magna derived from in-house laboratory cultures.
Study design
- Test type:
- static
- Water media type:
- other: ISO medium
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 250 mg/L expressed as CaCO3
- Test temperature:
- 21-22 °C
- pH:
- At test start: 7.8
At test end: 7.7 - 7.8 - Dissolved oxygen:
- At test start: 8.4 - 8.8 mg O2/L
At test end: 8.6 - 8.7 mg O2/L - Salinity:
- Not particularly stated, but detailed description of test medium composition given in the original study report.
- Nominal and measured concentrations:
- Nominal concentration: 100% v/v saturated solution
Measured at sampling time 0 hours: < LOQ (0.10 mg/L)
Measured at sampling time 48 hours: < LOQ (0.10 mg/L) - Details on test conditions:
- - Test vessels: open 250 mL glass jars containing approximately 200 mL of test preparation
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
The test vessels were covered to reduce evaporation and maintained in a temperature controlled room at approximately 22 °C with a photoperiod of 16 hours light (not exceeding 1500 lux) and 8 hours darkness with 20 minute dawn and dusk transition periods.
The daphnids were not individually identified, received no food during exposure and the test vessels were not aerated.
The control group was maintained under identical conditions but not exposed to the test item. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate used in separate study
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % v/v saturated solution
- Nominal / measured:
- nominal
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 other: % v/v saturated solution
- Nominal / measured:
- nominal
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: loading rate
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: loading rate
- Basis for effect:
- mobility
- Details on results:
- VERIFICATION OF TEST CONCENTRATIONS
Analysis of the test preparations at 0 and 48 hours showed measured test concentrations of less than the limit of quantification (LOQ) of the analytical method employed, which was determined to be 0.10 mg/L. This does not infer that no test item was in solution, just that any dissolved test item present was at a concentration of less than the LOQ.
IMMOBILIZATION DATA
There was no immobilization in 20 daphnids exposed to a test concentration of 100% v/v saturated solution for a period of 48 hours.
SUB-LETHAL EFFECTS
No sub-lethal effects of exposure were observed throughout the test. - Results with reference substance (positive control):
- Potassium dichromate was used as reference item at concentrations of 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L.
The 48-hour EC50 was 0.75 mg/L with 95% confidence limits of 0.69 to 0.82 mg/L, the NOEC was 0.56 mg/L. The results were within the normal range for this reference item. - Reported statistics and error estimates:
- not applicable
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Ascorbyl palmitate induced no immobility in Daphnia magna exposed to a 100% v/v saturated solution (NOEC), prepared by filtration (ca. 0.2 µm) of a test preparation with a loading rate of nominal 50 mg/L.
Owing to the extremely low solubility of ascorbyl palmitate in water, concentration levels toxic for crustaceans could not be reached. Therefore, the 48h-EC50 for Daphnia magna exceeded the maximum solubility of ascorbyl palmitate in water. - Executive summary:
A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.
A preliminary media preparation trial indicated that a saturated solution method of preparation was appropriate for this test item. Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test item at a nominal concentration of 100% v/v saturated solution for 48 hours at a temperature of approximately 22 °C under static test conditions. The test item solution was prepared by stirring an excess (50 mg/L) of test item in test water using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration (0.2 µm Sartorius Sartopore filter, first approximate 1 liter discarded in order to pre-condition the filter) to produce a 100% v/v saturated solution of the test item.
Immobilization and any adverse reactions to exposure were recorded after 24 and 48 hours.
Exposure of Daphnia magna to the test item gave EC50 values of greater than 100% v/v saturated solution. The No Observed Effect Concentration was 100% v/v saturated solution. This study showed that there were no toxic effects at saturation.
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.