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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 817-761-7 | 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
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:
- 14 - 24 Dec 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aqueous-phase aquatic toxicity testing of difficult test chemicals, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- EC Number:
- 817-761-7
- Cas Number:
- 765293-81-0
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol
- Test material form:
- other: waxy paste
- Details on test material:
- Appearance: White to pale yellow waxy paste
Test item storage: At room temperature
Stable under storage conditions until: 30 May 2019 (retest date)
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Preparation of Test Solutions
The batch of Plandool-H tested was a white to pale yellow waxy paste UVCB and not completely soluble in test medium at the loading rates initially prepared. No correction was made for the purity/composition of the test item.
Preparation of test solutions started with loading rates individually prepared at 1.0, 10 and 100 mg/L. A two-day period of magnetic stirring at 45°C was applied to ensure maximum dissolution of the test item in medium. The obtained mixtures were allowed to settle overnight (approximately a period of 22 hours). Thereafter, the aqueous Water Accommodated Fractions (WAFs) were collected by means of siphoning and used as test concentrations. All test solutions were clear and colorless at the end of the preparation procedure.
Any residual volumes were discarded.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test System
Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions.
Source: In-house laboratory culture with a known history.
Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics: Daphnia, less than 24 hours old, from parental daphnids of more than two weeks old.
Breeding
Start of each batch: Approximately 250 newborn daphnids, i.e. less than 3 days old, were placed into 5 litres of medium in an all-glass culture vessel.
Maximum age of the cultures: 4 weeks
Renewal of the cultures: After 7 days of cultivation, half of the medium twice a week.
Temperature of medium: 18-22°C
Feeding: Daily, a suspension of fresh water algae.
Culture medium: M7, as prescribed by Dr. Elendt-Schneider (Elendt, B.-P., 1990: Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus. Protoplasma 154, 25-33).
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- The following salts (analytical grade) were added to tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands): CaCl2.2H2O: 211.5 mg/L; MgSO4.7H2O: 88.8 mg/L; NaHCO3: 46.7 mg/L; KCl: 4.2 mg/L.
The hardness of test medium expressed as CaCO3: 180 mg/L - Test temperature:
- 19 - 20°C
- pH:
- 7.9 - 8.2
- Dissolved oxygen:
- 7.3 - 8.9 mg/L
- Details on test conditions:
- Test duration: 48 hours
Test type: Static
Test vessels: 60 mL, all-glass
Test medium: The following salts (analytical grade) were added to tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands): CaCl2.2H2O: 211.5 mg/L; MgSO4.7H2O: 88.8 mg/L; NaHCO3: 46.7 mg/L; KCl: 4.2 mg/L.
Number of daphnids: Control and highest concentration: 20 per test group; Intermediate concentrations: 10 per concentration.
Loading: 5 per vessel containing 50 mL of test solution.
Light: A daily photoperiod of 16 hours.
Feeding: No feeding
Aeration: No aeration of the test solutions was applied.
Introduction of daphnids: 17 minutes after preparation of the test solutions. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (tested periodically)
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: the effect based on loading rate
- Details on results:
- No biologically relevant immobility was observed in the control and at any of the test concentrations throughout the exposure period.
In conclusion, the 48h-EL50 for Daphnia magna exposed to Plandool-H exceeded the maximum solubility of the test item in test medium, i.e. exceeded a loading rate of 100 mg/L. - Results with reference substance (positive control):
- The 24h-EC50 in this reference test with K2Cr2O7 was within the expected range of 0.6 and 2.1 mg/L as specified in ISO International Standard 6341, October 2012. The 48h-EC50 was within the expected range of 0.28 and 0.75 mg/L, which is based on reference tests performed at the Test Facility during the last ten years.
The 24h-EC50 was 0.84 mg/L with a 95% confidence interval between 0.73 and 0.97 mg/L.
The 48h-EC50 was 0.47 mg/L with a 95% confidence interval between 0.41 and 0.55 mg/L
In conclusion, the sensitivity of this batch of Daphnia magna was in agreement with ISO International Standard 6341, October 2012 and the historical data collected at Charles River Den Bosch.
Period of reference test: 21 - 23 Jan 2019
Any other information on results incl. tables
ANALYSIS
No EL50-values could be calculated because the observed effects were below 50% (EL50 > maximum soluble concentration tested)
Measured Concentrations
The results of analysis of the samples taken during the test are described in the following table:
Time of sampling [hours] |
Date of sampling |
Date of analysis1 |
Loading rate2[mg/L] |
Concentration analyzed [mg/L] |
Relative to initial [%] |
0 |
17 Dec 2018 |
24 Dec 2018 |
0 100 |
3 n.d. |
|
48 |
19 Dec 2018 |
24 Dec 2018 |
0 100 |
n.d. n.d. |
n.a. n.a. |
1Samples were stored in the freezer (≤-15°C) until the day of analysis.
2A water accommodated fraction (WAF) prepared at the loading rate.
3A small response was observed but the concentration was lower than the determined limit of detection of 0.078 mg/L taking a dilution factor of 2 into account. This was considered caused by carry over, as a similar response was observed in the preceding analytical blank.
n.d. Not detected. The limit of detection of the analytical method was determined to be 0.078 mg/L taking a dilution factor of two into account.
n.a. Not applicable.
Samples taken from the highest test concentration and the control were analysed. No test item was detected throughout the test at the highest concentration tested.
It should be noted that a very small response was measured in the control sample at the start of the test, which was caused by carry-over. Since not more than 10% of the daphnids showed signs of disease or stress (i.e. 10%) and this response was caused by carry-over, this small response has no effect on the study results or conclusions.
Based on these results and by decision of the sponsor, effect parameters were reported and expressed as loading rates.
Immobility
Table 1 shows the responses recorded during the test.
No biologically relevant immobility was observed in the control and at any of the test concentrations throughout the exposure period. It should be noted that ≤10% immobility or entrapment is allowed in the control, and therefore effects <10% were considered biologically not relevant.
The responses recorded in this test allowed for reliable determination of an EL50.
Table 1 Number of Introduced Daphnids and Incidence of Immobility in the Test
Time (h) |
Replicate |
Control |
Plandool-H Loading rate 1.0 mg/L |
Plandool-H Loading rate 10 mg/L |
Plandool-H Loading rate 100 mg/L |
0 |
A |
5 |
5 |
5 |
5 |
0 |
B |
5 |
5 |
5 |
5 |
0 |
C |
5 |
|
|
5 |
0 |
D |
5 |
|
|
5 |
0 |
Total introduced |
20
|
10
|
10
|
20
|
24 |
A |
0 |
1 |
0 |
0 |
24 |
B |
0 |
0 |
0 |
0 |
24 |
C |
0 |
|
|
0 |
24 |
D |
0 (2) |
|
|
0 |
24 |
Total immobilized Effect % |
0 0 |
1 5 |
0 0 |
0 0 |
48 |
A |
0 |
0 |
0 |
0 |
48 |
B |
0 |
0 |
0 |
0 |
48 |
C |
0 |
|
|
0 |
48 |
D |
0 |
|
|
0 |
48 |
Total immobilized Effect % |
0 0 |
0 0 |
0 0 |
0 0 |
( ) between brackets: number of daphnids observed trapped at the surface of the test solutions. These organisms were reimmersed into the respective solutions before recording of mobility.
Experimental Conditions
The results of measurement of pH and oxygen concentrations (mg/L) are presented in Table 3. These test conditions remained within the limits prescribed by the study plan (pH: 6-9, not varying by more than 1.5 units; oxygen: ≥3 mg/L at the end of the test).
The temperature continuously measured in a temperature control vessel varied between 19 and 20°C during the test, and complied with the requirements as laid down in the study plan (18-22°C, constant within ±1°C).
Table 3 pH and Oxygen Concentrations (mg/L) During the Test
Plandool-H Loading rate (mg/L) |
Start (t=0 h) O2 |
Start (t=0 h) pH |
End (t=48 h) O2 |
End (t=48 h) pH |
Control |
8.9 |
7.9 |
8.9 |
8.1 |
100 |
7.3 |
8.2 |
8.5 |
8.1 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
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.