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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 905-983-8 | 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:
- 2020 - 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- adopted 2nd October 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Prior to defrosting and analysis of the test samples, acetonitrile was added to the frozen samples (e.g. 25 mL acetonitrile per 50 mL water sample). The samples were defrosted and vigorously homogenised on a Vortex mixer (at least 1 min). An aliquot of approx. 1 mL was transferred into HPLC vials for determination by HPLC-MS/MS.
- Vehicle:
- no
- Details on test solutions:
- Based on the results of preliminary non-GLP range finding tests, the following nominal
concentrations in a geometrical series (spacing factor: 2.0) will be tested in the definitive test:
100, 50.0, 25.0, 12.5 and 6.25% of a filtrate at a loading rate of 10 mg test item/L.
A saturated stock solution was prepared in test medium at a nominal loading rate of 10 mg test item/L as described below.
Stock solutions (S) of the test item in test medium were prepared by weighing amounts equivalent to 10 mg of the test item per 1 L of dilution medium into a volumetric glass flask of appropriate volume, containing less than its nominal volume. The resulting solution (>> 10 mg test item/L) was intensely stirred on a magnetic stirrer at 1300 rpm at room temperature in the dark for 15 - 21 minutes to ensure a homogeneous distribution of the test item in the test medium.
Thereafter the volumetric flask, containing the pre-dissolved test item, was filled up to the mark with test medium used to prepare the final stock solution at a nominal loading rate of 10 mg test item/L. This stock solution was termed S1, and was then stirred for 24±3 hours at 750 rpm at ambient temperature in the dark.
Subsequently the stock solution S1 was filtered using a glass fibre filter with an average retention capacity of 0.4 µm (Macherey-Nagel, MN GF-5). The filtrate (stock solution S2) was visually examined for un-dissolved/particulate matter (using the Tyndall effect).
The filtrate was termed stock solution (S2) and was used to produce the desired test item concentrations. All further calculations of the nominal concentration are expressed in % of filtrate at a loading rate of 10 mg test item/L. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- The daphnids were held in a specific medium (Elendt Medium M4 as specified in the test guideline). The vessels containing the stock culture were on a 16/8 hours light/dark cycle at a target temperature of 20±2 °C. The daphnids were fed with green algae (Desmodesmus subspicatus) and yeast.
Material of stock vessel: glass
Volume of medium per stock vessel: 1.8 L
Depth of medium in the stock vessel: approximately 14.5 cm
Number of daphnids kept as stock per culture vessel (batch size): approximately 20
Renewal of medium: batchwise, twice per week
Light intensity: 50–1000 lx
Aeration: none
Feeding frequency: 3-4 times per week
The selected holding vessels designated for production of the neonates for the test were cleared of all mixed-aged young daphnids on the day before test start. These vessels had a record of more than one brood and contained parental daphnids aged less than 28 days. On the day of test start (day 0) all newly produced neonates of these vessels were < 24 hours old. These neonates were collected for the test. - Test type:
- semi-static
- Water media type:
- other: Elendt medium M4 was used for the test
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- Water hardness in mg CaCO3/L was calculated by multiplication of the hardness-value in °dH by 17.86. Water hardness [°dH] minimum: 13.6 maximum: 14.5. Water hardness (mg CaCO3/L] minimum: 243 maximum: 259
- Test temperature:
- manual measurements (n=12): 19.9 - 21.6 °C
automatic measurements (n=511): 20.2 - 22.0 °C - pH:
- pH: minimum 7.5 maximum 9.0
- Dissolved oxygen:
- dissolved oxygen [% of air sat. value]: minimum 88 maximum 132
dissolved oxygen [mg/L]: minimum 7.7 maximum 11.5 - Salinity:
- The medium consists of trace elements, vitamins and macro-nutrients in the following final concentrations (in mg/L):
Trace elements: Macronutrients:
H3BO3 2.86 CaCl2 × 2 H2O 293.8
MnCl2 × 4 H2O 0.361 MgSO4 × 7 H2O 123.3
LiCl 0.306 KCl 5.8
RbCl 0.071 NaHCO3 64.8
SrCl2 × 6 H2O 0.152 Na2SiO3 × 9 H2O 10.0
NaBr 0.016 NaNO3 0.274
Na2MoO4 × 2 H2O 0.063 KH2PO4 0.143
CuCl2 × 2 H2O 0.017 K2HPO4 0.184
ZnCl2 0.013
CoCl2 × 6 H2O 0.010 Vitamins:
KI 0.0033 Thiamine hydrochloride 0.075
Na2SeO3 0.0022 Cyanocobalamin 0.001
NH4VO3 0.00058 Biotin 0.00075
Na2EDTA × 2 H2O 2.5
FeSO4 × 7 H2O 1.0 - Conductivity:
- The conductivity [µS/cm] of the medium M4 batches was determined before use:
02 Oct 2020: 636
19 Oct 2020: 647
29 Oct 2020: 678 - Nominal and measured concentrations:
- Nominal concentrations were given as a percentage of the filtrate of a stock solution with a concentration of
10 mg test item/L:
6.25% corresponding to 0.625 mg test item/L
12.5% corresponding to 1.25 mg test item/L
25.0% corresponding to 2.5 mg test item/L
50.0% corresponding to 5.0 mg test item/L
100% corresponding to 10 mg test item/L
Concentrations were measured over the course of time. Initially measured concentrations for the various nominal concentrations are:
Nominal 6.25% (0.625 mg test item/L), measured 0.0199 mg test item/L
Nominal 12.5% (1.25 mg test item/L), measured 0.0146 mg test item/L
Nominal 25.0% (2.5 mg test item/L), measured 0.0473 mg test item/L
Nominal 50.0% (5.0 mg test item/L), measured 0.112 mg test item/L
Nominal 100% (10 mg test item/L), measured 0.203 mg test item/L
Stock Solution: Nominal 100% (10 mg test item/L), measured 0.231 mg test item/L - Details on test conditions:
- Material and methods:
Test system: Daphnia magna (Straus)
Medium: Elendt Medium M4
Endpoints: NOEC/LOEC, ECx for reproduction and mortality
Biological parameters: - reproduction as assessed by fecundity (total number of living offspring (F1));
- mortality/survival as assessed by immobility of parental (F0) daphnids
Test duration: 21 days
Temperature: 19.9–21.6 °C (manual measurement; n = 12);
20.2–22.0 °C (automatic measurement in test medium; n = 511)
Photoperiod: 16 h light/8 h dark
Aeration: no aeration during exposure
Test units: 100 mL glass beakers, covered by glass lids
Volume of test solution per test vessel: 50–60 mL
Renewal of test solution during exposure: three times per week
Number of daphnids per test vessel: one at start of exposure
Feeding during exposure: three times per week, fresh algae suspension of Desmodesmus subspicatus; 0.15–0.20 mg C/daphnia × d
Test item concentrations (nominal): 100, 50.0, 25.0, 12.5 and 6.25% of a filtrate at a loading rate of 10 mg test item/L plus a control
Number of replicates per test concentration and control: 10
Chemical analysis of test concentrations: once per week (fresh and aged solutions) - Reference substance (positive control):
- no
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 8.68 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.34 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Key result
- Duration:
- 21 d
- Dose descriptor:
- other: EC20
- Effect conc.:
- 10.45 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 4.05 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 26.6 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks:
- parental
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 26.6 µg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks:
- parental
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 2.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Duration:
- 21 d
- Dose descriptor:
- other: EC20
- Effect conc.:
- 3.138 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 1.029 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks:
- parental
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks:
- parental
- Details on results:
- Sublethal effects as observed in the living parental daphnids were recorded throughout the treatments. A slight increase of the frequency of sublethal observations (e.g. daphnids trapped at the water surface) was noted towards higher concentration levels. Detailed observations are tabulated below
Treatment [% of filtrate]: Control 6.25 12.5 25.0 50.0 100
Observation Code frequency of observation
Daphnid temporarily
floating on water surface1 a 2 3 10 11 8 8
Daphnid lay on the bottom
of the test vessel b 0 3 0 0 1 2
Daphnid showed reduced
swimming activity c 0 3 0 0 1 0
Aborted eggs d 0 3 2 4 3 6
Algae on antennae/carapace e 0 2 2 1 2 3
Immobile offspring f 2 0 0 0 1 0
Immobile parents M 0 1 0 0 1 0
1: upon observation, floating daphnids were gently pushed under the water surface; afterwards they showed normal swimming behaviour. - Validity criteria fulfilled:
- yes
- Conclusions:
- In a “Daphnia Magna, reproduction test" according OECD TG 211 the toxicity of the Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate on daphnia magna was assessed. Over the course of 21 d no concentration-response relationship was observed for parental daphnid survival/immobility resulting in a NOEC = 26.6 µg/L and a LOEC >26.6 µg/L. For the endpoint "reproduction based on surviving F0 daphnids" the following effect concentrations were observed: EC10 = 4.05 µg/L, EC20 = 10.45 µg/L, NOEC 4.34 µg/L and LOEC = 8.68 µg/L
The test was conducted with a nominal test concentration of max. 10 mg test item/L. The test-item concentration was also measured over the course of the test. - Executive summary:
In a “Daphnia Magna, reproduction test" according OECD TG 211 the toxicity of the Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate on daphnia magna was assessed.
Young female Daphnia, aged less than 24 hours at the start of the test, were exposed to a range of concentrations, nominally in percentages of a filtrate of a stock solution with a concentration of 10 mg/L. The resulting nominal test concentrations are: 0.625 mg/L, 1.25 mg/L, 2.5 mg/L, 5.0 mg/L and 10 mg/L.
Measured concentrations over the course of the study revealed much lower concentrations resulting in effect concentrations in the lower µg/L range.
Over the course of 21 d no concentration-response relationship was observed for parental daphnid survival/immobility resulting in a NOEC = 26.6 µg/L and a LOEC >26.6 µg/L.
For the endpoint "reproduction based on surviving F0 daphnids" the reproductive output of the Daphnia exposed to the test item was compared to that of the control in order to determine the effect concentrations according to Williams Multiple Sequential-t Test Procedure.
Following effect concentrations were observed for "reproduction based on surviving F0 daphnids": EC10 = 4.05 µg/L, EC20 = 10.45 µg/L, NOEC 4.34 µg/L and LOEC = 8.68 µg/L
Reference
For further information on biological endpoints refer to tables 4 – 6 in the attached document "Summary of relevant tables for Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate: A Study on the Chronic Toxicity to Daphnia magna (Egeler, Witte, 2021) Study No. 20AN1DB"
Description of key information
In a “Daphnia Magna, reproduction test" according OECD TG 211 the toxicity of the Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate on daphnia magna was assessed. Over the course of 21 d no concentration-response relationship was observed for parental daphnid survival/immobility resulting in a NOEC = 26.6 µg/L and a LOEC >26.6 µg/L. For the endpoint "reproduction based on surviving F0 daphnids" the following effect concentrations were observed: EC10 = 4.05 µg/L, EC20 = 10.45 µg/L, NOEC 4.34 µg/L and LOEC = 8.68 µg/L
The test was conducted with a nominal test concentration of max. 10 mg test item/L. The test-item concentration was also measured over the course of the test.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- NOEC
- Remarks:
- The derived EC10 lies slightly below the NOEC. As the NOEC is an observed value, this value is chosen for the assessment.
- Effect concentration:
- 4.34 µg/L
Additional information
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.