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EC number: - | 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Jul - 12 Aug 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.20 (Daphnia magna Reproduction Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of Health, United Kingdom
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control, 1, 10, 100 mg/L
- Sampling method: Samples were taken after 0, 3 (old), 5 (fresh), 7 (old), 10 (fresh), 12 (old), 19 (fresh) and 21 (old) d - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Nominal amounts of test item (5.0, 50 and 500 mg) were each separately added to the surface of 5 liters of test water to give the 1.0, 10 and 100 mg/L loading rates, respectively. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 95 hours and the mixtures allowed to stand for 1 hour. A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. Microscopic inspection of the WAFs showed no micro-dispersions or undissolved test item to be present. The aqueous phase or WAF was removed by mid-depth siphoning (the first approximate 75-100 mL discarded) to give the 1.0, 10 and 100 mg/L loading rate WAFs.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Source: in-house culture
- Age of parental stock (mean and range, SD): 1st instar Daphnia magna
- Feeding during test: Each daphnid received approximately 5 to 10 μL of an algal suspension (Desmodesmus subspicatus) and approximately 20 μL of Tetramin® flake food suspension daily. Feeding was at a level of approximately 0.1 to 0.2 mg carbon/daphnid/day, dependent on the age and size of the animals. Equal amounts of food were given to each daphnid.
- Culture conditions: Adult daphnia were maintained in 150 mL glass beakers containing Elendt M7 mediumat approximately 20 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension. Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 248 - 268 mg/L as CaCO3
- Test temperature:
- 21 - 22 °C
- pH:
- 7.6 - 8.1
- Dissolved oxygen:
- 8.0 - 9.0 mg O2/L
- Nominal and measured concentrations:
- nominal: control, 1, 10, 100 mg/L
measured control: < LOQ
measured 1 mg/L: < LOQ
measured 10 mg/L: 0.0202 mg/L (3 d), 0.0190 mg/L (5 d), < LOQ (7 d), 0.0181 mg/L (day 10), < LOQ (day 12), < LOQ (day 19), < LOQ (day 21)
measured 100 mg/L: 0.0240 mg/L (3 d), 0.0269 mg/L (5 d), 0.0233 mg/L (7 d), 0.0199 mg/L (day 10), < LOQ (day 12), 0.00780/0.00905 mg/L (day 19, duplicate samples), < LOQ (day 21, duplicate samples) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 150 mL glass vessels
- Type (delete if not applicable): closed with a plastic lid
- Material, size, headspace, fill volume: glass, 150 mL, headspace: 50 mL, fill volume: 100 mL
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): renewed 3 times a week on days 3, 5, 7, 10, 12, 14, 17 and 19.
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h dark with 20 min transition period
- Light intensity: 592 - 718 lux
EFFECT PARAMETERS MEASURED
- Mobility and length of the parental generation, numbers of live and dead F1 daphnia and the number of discarded unhatched eggs was counted every day. - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- EL10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOELR
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- reproduction
- Details on results:
- - Mortality of parent animals: 0%
- No. of offspring produced per day per female: 99.1 (control), 105.9 (1 mg/L), 103.4 (10 mg/L), 101.7 (100 mg/L)
- Body length and weight of parent animals: After 21 days the length of each surviving adult was determined. The results showed that there were no statistically significant differences (P≥ 0.05) between the control and the 1.0, 10 and 100 mg/L loading rate WAF test groups in terms of length of the daphnids after 21 days exposure to the test item.
- Visual observation of test solutions: clear and colorless (microscopic observation of the WAF)
- Time to first brood release or time to hatch: 7-9 d - Reported statistics and error estimates:
- Results from the control and the each test group were compared using one way analysis of variance incorporating Bartlett's test for homogeneity of variance (Sokal and Rohlf 1981) and the Williams test for differences between treatment means when several dose levels are compared with a zero dose control (Williams 1971).
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Duration:
- 21 d
- Dose descriptor:
- EL10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOELR
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- reproduction
Referenceopen allclose all
Table 1: Total cumulative production of live young
Nominal loading rate [mg/L] |
Day |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
87 |
126 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
106 |
159 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
113 |
141 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
15 |
103 |
139 |
Nominal loading rate [mg/L] |
Day |
||||||||||
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
|
Control |
123 |
271 |
323 |
323 |
462 |
504 |
506 |
751 |
775 |
775 |
991 |
1 |
159 |
373 |
396 |
396 |
535 |
553 |
591 |
837 |
858 |
858 |
1059 |
10 |
141 |
299 |
326 |
326 |
480 |
521 |
527 |
764 |
811 |
811 |
1034 |
100 |
139 |
209 |
320 |
342 |
498 |
520 |
543 |
746 |
795 |
795 |
1017 |
Table 2: Body length of surviving adults at day 21
Nominal loading rate [mg/L] |
Individual daphnia lengths [mm] |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|
Control |
3.9 |
4.0 |
3.9 |
3.9 |
3.9 |
4.2 |
3.8 |
3.5 |
3.9 |
3.9 |
1 |
3.9 |
3.7 |
4.1 |
3.8 |
4.0 |
3.9 |
3.8 |
3.9 |
4.0 |
4.0 |
10 |
3.9 |
4.0 |
4.0 |
3.9 |
4.0 |
3.8 |
3.8 |
3.8 |
3.9 |
3.9 |
100 |
3.9 |
3.5 |
3.7 |
4.1 |
3.9 |
3.9 |
3.9 |
3.6 |
3.8 |
3.8 |
Description of key information
No effects up to the limit of water solubility (OECD 211).
Key value for chemical safety assessment
Additional information
Since no studies investigating the long-term toxicity of fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1) to aquatic invertebrates are available, in accordance to Regulation (EC) No 1907/2006, Annex XI, 1.5 a read-across to the structurally related source substance carboxylic acids, C5-9, hexaesters with dipentaerythritol (CAS 67762-52-1) was conducted. The source substance carboxylic acids, C5-9, hexaesters with dipentaerythritol is structurally similar to the target substance. Both substances are characterized by the same alcohol component (dipentaerythritol) fully esterified with fatty acids of C7, C8, C9 and C10 (target substance) and C5, C7, C9 (source substance. The difference in the chemical structure between both substances is not considered to affect the toxicity since both substances do not contain any functional group associated with a specific mode of action. This read-across is justified in detail in the analogue justification in IUCLID Section 13.
The study with the source substance was conducted according to OECD 211 (GLP) with Daphnia magna as test organism. Since the test item is poorly soluble in water three different loading rates were prepared (1, 10 and 100 mg/L). The water accommodated fractions (WAFs) were prepared by adding appropriate amounts of the test item to test medium followed by 95 h stirring and 1 h settling period. The aqueous phase was removed by mid-depth siphoning. Microscopic observations did not indicate any undissolved micro-dispersions or undissolved test material. After semi-static exposure for 21 days no significant effects on the survival and reproduction rate were determined. A NOELR (21 d) ≥ 100 mg/L was derived. The validity criteria are met indicating that the study results are considered to be valid (0% mortality of parent animals in control; mean number of living offspring per parent animal in the control: 99.1).
Based on the available result from one structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that the same result is expected when testing the target substance.
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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