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EC number: 947-748-2 | 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
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- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Jan - 16 Jan 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (no purity)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 202 "Daphnia sp, Acute Immobilisation Test and Reproduction Test" (1984)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom (date of inspection 28 Feb 2000)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Water samples were taken from the control (replicates R1-R2 pooled) and the 1000 mg/L loading rate WAF test group (replicates R1-R2 and R3-R4 pooled) at 0 and 48 h.
- Sample storage conditions before analysis: Duplicate samples of the 1000 mg/L loading rate WAF test groups at 0 h were taken and stored frozen (approx -20°C) for further analysis if necessary. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: An amount of test material (10 g) was added to the surface of 10 L of reconstituted water to give a 1000 mg/L loading rate. After the addition of the test material, the reconstituted water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a slight dimple at the water surface. This was stirred for 23 h. After stirring the mixture was allowed to stand for 1 h. The aqueous phase was removed by mid-depth siphoning (the first 75-100 mL discarded) to give the 1000 mg/L loading rate WAF. Microscopic inspection of the WAF showed no micro-dispersions or undissolved test material to be present.
- Controls: Reconstituted water
- Evidence of undissolved material: no - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Source: 1st instar of an in-house laboratory culture
- Age at study initiation: < 24 h
- Method of breeding: Adult Daphnia were maintained in polypropylene vessels containing approx. 2 L of reconstituted water in a temperature controlled room at 21 °C. The lighting cycle was 16 h light and 8 h dark. Each culture was fed daily with a suspension of algae (Chlorella sp.). Reproduction was by parthenogenesis. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Test temperature:
- 21.8 °C (0 h), 20.6 °C (24 h), 20.8 °C (48 h)
- pH:
- 7.6-7.9
- Dissolved oxygen:
- 90-98%
- Nominal and measured concentrations:
- Nominal: control - 1000 mg/L
Measured: < Limit of quantification (0.032 mg/L) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL glass jars containing approx. 200 mL of test preparation
- Type: covered to reduce evaporation
- No. of organisms per vessel: 10
- No. of vessels per concentration: 4
- No. of vessels per control: 2
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h dark with 20 min dawn and dusk transition periods
EFFECT PARAMETERS MEASURED: Immobilisation was recorded after 24 and 48 h test duration.
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10, 100, 1000 mg/L (WAFs)
- Results used to determine the conditions for the definitive study: No immobilisation was observed. - Reference substance (positive control):
- no
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: no mortality was observed in the controls
- Effect concentrations exceeding solubility of substance in test medium: The nominal concentration of 1000 mg/L exceeded the water solubility of the test item. - Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Aug - 06 Nov 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A WAF of nominal loading rate of 100 mg/L was prepared by adding 200 mg test substance to 2 L deionized reverse osmosis water. The mixture was stirred for 23 hours and mixture allowed was allowed to stand for 1 hour after stirring. The WAF was used as test solution.
- Controls: For TOC analyses two duplicates of WAF were prepared One loading rate was stirred for a period of 23 hours and the other for a period of 95 hours. After a 1-Hour standing period the mixtures were then removed by siphon and samples taken for Total Organic Carbon analysis. The TOC concentrations were below the limit of quantitation (1.0 mg C/L).
- Evidence of undissolved material: no undissolved test item found (microscopic inspection of WAF) - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Source: bred at the testing facility
- Age at study initiation: < 24 hours
- Feeding during test: none
ACCLIMATION
- Acclimation period: yes
- Type and amount of food: algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension.
- Feeding frequency: daily - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 250 mg/L CaCO3
- Test temperature:
- 21 - 22 °C
- pH:
- 7.9 - 8.1
- Dissolved oxygen:
- 8.3 - 8.6 mg/l
- Nominal and measured concentrations:
- loading rate: 100 mg/L (WAF)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass jars(250 mL)
- Type (delete if not applicable): open / closed
- Material, size, fill volume: glass, 200 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Conductivity: <5 μS cm-1
- Intervals of water quality measurement: water temperature daily, O2 concentration and pH at start and termination of the test
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 h day-night regime
- Light intensity: 647 - 980 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mobility was recored after 24 and 48 hours after test start
TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 1.0, 10 and 100 mg/L (nominal loading rate, WAF)
- Results used to determine the conditions for the definitive study: EL50 (48 h) > 100 mg/L (WAF) - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- loading rate (WAF)
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- loading rate (WAF)
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- The positive control was conducted between 6 June 2012 and 8 June 2012. An EC50 (48 h) of 0.45 mg/L was reported.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the analogue justification attached to chapter 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- loading rate (WAF)
- Basis for effect:
- mobility
- Remarks on result:
- other: source, RA-A, CAS 68440-09-5, Harlan, 2012, D. magna, 48 h
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- mobility
- Remarks on result:
- other: source, RA-A, CAS 131459-39-7, Safepharm, 2003, D. magna 48 h
- Conclusions:
- The substance will not exhibit short-term effects to aquatic invertebrates up to the limit of water solubility.
Referenceopen allclose all
No effects were observed in the range of water solubility at a nominal concentration of 1000 mg/L (WAF). Analysis of the test preparations at 0 and 48 h showed the measured test concentrations to be less than the limit of quantification of the analytical method (< 0.032 mg/L) (Table 1).
Table 1: Chemical analysis of the test loading rates
Samples |
Nominal loading rate [mg/L] |
Concentration found [mg/L] |
0 h |
control |
< LOQ |
1000 R1-R2 |
< LOQ |
|
1000 R3-R4 |
< LOQ |
|
48 h |
control |
< LOQ |
1000 R1-R2 |
< LOQ |
|
1000 R3-R4 |
< LOQ |
Description of key information
Key value for chemical safety assessment
Additional information
Since no studies investigating the short-term toxicity of Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid to aquatic invertebrates are available, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5, a read-across to the structurally related source substances Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) and 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) was conducted.
The source substances are representative to evaluate the short-term toxicity of the target substance to aquatic invertebrates. This read-across is justified in detail within the analogue justification in IUCLID Section 13.
The target substance Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid is characterized as a UVCB substance with pentaerythritol as alcohol component. Esterification of pentaerythritol gives mainly tri- and tetraesters of long chain fatty acids C16-C20.
The source substance Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) is characterized as a UVCB substance with pentaerythritol as alcohol component. Pentaerythritol is esterified by long chain fatty acids C10-C28.
The source substance 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) is characterized by the alcohol component pentaerythritol. Esterification gives mainly tetraesters of 3,5,5-trimethylhexanoic acid and valeric acid.
The study with the source substance Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) was performed in a static test design according to OECD 202 (GLP).Daphnia magnawere exposed to a single nominal loading rate of 100 mg/L (prepared as WAF). No immobility was observed after an exposure period of 48 h. Hence an EL50 (48 h) of > 100 mg/L and a NOELR of ≥ 100 mg/L was determined.
The study with the source substance 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS 131459-39-7) was performed in a static test design according to OECD 202 and EU method C.2 (GLP).Daphnia magnawere exposed to a single nominal loading rate of 1000 mg/L (prepared as WAF). No immobility was observed after an exposure period of 48 h. Hence an EL50 (48 h) of > 1000 mg/L and a NOELR of ≥ 1000 mg/L was determined.
Based on the results for the structurally related read-across substances (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that no toxicity of the target substance Fatty acids lanolin, di, tri- and tetraesters with pentaerythritol and rape fatty acid to aquatic invertebrates is expected up to the limit of the water solubility (< 0.15 mg/L).
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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