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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-479-5 | 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:
- 2012-12-16 to 2013-01-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol
- EC Number:
- 701-479-5
- Molecular formula:
- C42H82O7
- IUPAC Name:
- C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol
- Details on test material:
- - Name of test material (as cited in study report): Diglycerol diisostearate
- Physical state: Viscous liquid, light yellow
- Analytical purity: 100 % (w/w) UVCB
- Purity test date: 2012-02-29
- Lot/batch No.: ESD0012304
- Expiration date of the lot/batch: 2013-06-09
- Stability under test conditions: Stable
- Storage condition of test material: Keep container tightly closed and dry.
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
- Details on sampling:
- - Concentrations: 6.25 - 12.5 - 25 - 50 - 100 mg/L (WAF)
- Sampling method: All tested loading levels of the test item and the control were analytically verified by analysis of total organic carbon (TOC, according to DIN EN 1484) at the start of the exposure (0 h) and at the end of the exposure (48 h).
For the old media, an additional replicate of each loading level and the control was prepared, with test media, but without daphnids, and incubated under test conditions until sampling.
- Sample storage conditions before analysis: The samples were stored at 6 ± 2 °C until analysis, if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Five water accommodated fractions (WAF) were prepared with nominal loadings of the test item in the range of 6.25 to 100 mg/L, set up in a geometric series with a separation factor of 2.
For each loading level, an appropriate amount of the test item was weighed out and transferred into a measuring flask with an appropriate amount of dilution water. For details, see the table below.
These dispersions were stirred for 72 h with 1100 rpm at room temperature. After a separation phase of 1 h, the WAFs were taken from the homogeneous liquid phase (the approximate centre of the glass flask) and used for testing.
The test loadings are based on the results of a non GLP preliminary range finding test under static conditions.
- Eluate: Dilution water
- Differential loading: 6.25 - 12.5 - 25 - 50 - 100 mg/L
- Controls: Dilution water without test item, tested under the same conditions as the test goups
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- Lufthygiene (WaBoLu), further own breeding
- Age at study initiation (mean and range, SD): 2 to 24 h
- Method of breeding: In 2-3 L glass vessels with appr. 1.8 L culture medium, at 20 +/- 2 °C, in an incubator, 16 h illumination, illumination strength max. 20 µExm-2 x s-1
- Feeding during test: No feeding
ACCLIMATION
- Acclimation period: 2 h
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: No feeding
- Health during acclimation (any mortality observed): Healthy, no mortality observed
DILUTION WATER:
Dilution water ISO test water, according to OECD 202, Annex 3:
Component Concentration [mg/L]
KCl 5.76
NaHCO3 64.8
CaCl2 2 H2O 294
MgSO4 7 H2O 123
pH-value: 7.8 0.2
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- No
Test conditions
- Hardness:
- Dilution water at test start: 246 (mg CaCO3/L)
- Test temperature:
- 21.5 °C (Water)
- pH:
- Water Quality Parameters at the Start of the Exposure (0 h)
(measured in one additional replicate per concentration level and control)
Diglycerol diisostearate
Nominal Loading Rate
of the Water Accommodated
Fraction (WAF)
[mg/L] pH-Value
100 7.64
50.0 7.68
25.0 8.02
12.5 8.03
6.25 7.99
Control 7.87
Water Quality Parameters at the End of the Exposure (48 h)
(measured in all replicates)
Diglycerol diisostearate
Nominal Loading Rate
of the Water Accommodated
Fraction (WAF)
[mg/L] pH-Values
Replicates
1 2 3 4
100 7.69 7.68 7.67 7.67
50.0 7.70 7.68 7.68 7.66
25.0 7.71 7.71 7.71 7.71
12.5 7.72 7.73 7.72 7.72
6.25 7.74 7.73 7.74 7.72
Control 7.81 7.76 7.75 7.76 - Dissolved oxygen:
- Water Quality Parameters at the Start of the Exposure (0 h)
(measured in one additional replicate per concentration level and control)
Diglycerol diisostearate
Nominal Loading Rate
of the Water Accommodated
Fraction (WAF)
[mg/L] Dissolved
O2-Concentration
[mg/L]
100 8.48
50.0 8.57
25.0 8.44
12.5 8.55
6.25 8.68
Control 8.52
Water Quality Parameters at the End of the Exposure (48 h)
(measured in all replicates)
Diglycerol diisostearate
Nominal Loading Rate
of the Water Accommodated
Fraction (WAF)
[mg/L] Dissolved O2 –Concentration [mg/L]
Replicates
1 2 3 4
100 8.46 8.43 8.41 8.39
50.0 8.28 8.32 8.36 8.37
25.0 8.35 8.31 8.35 8.43
12.5 8.43 8.45 8.39 8.36
6.25 8.39 8.45 8.34 8.40
Control 8.67 8.33 8.42 8.44 - Salinity:
- Not measured, freshwater
- Nominal and measured concentrations:
- please refer to "Any other information on materials and methods"
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers, 50 mL
- Type (delete if not applicable): closed with parafilm
- Material, size, headspace, fill volume: Glass beakers (4 cm ID x 7 cm H), 50 mL
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): static test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): None
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: see above
- Conductivity: Dilution water at test start:632 µS/cm
- Culture medium different from test medium: Elendt M4 acc. to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
- Intervals of water quality measurement: At test start and test end
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16:8 light:dark cycle
- Light intensity: Diffuse light, illumination strength max. 20 µE x m-2 x s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility was determined in all groups after 24 h and 48 h.
TEST CONCENTRATIONS
- Range finding study:
Immobilization Rates in the non GLP Preliminary Range Finding Test
(n = 20, divided into 2 replicates with 10 daphnids each)
Diglycerol diisostearate
Nominal Loading Rate
of the Water Accommodated
Fraction (WAF)
[mg/L] IMMOBILIZATION [%]
24 h 48 h
Replicates Replicates
1 2 MV 1 2 MV
100 60 70 65 100 100 100
10 0 0 0 0 0 0
1 0 0 0 0 0 0
Control 0 0 0 0 0 0 - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 12.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: Loading rate is > water solubility
- Details on results:
- - Mortality of control: 0 %
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50/LC50: 1.60 (CI 1.40 - 1.80) mg/L
Any other information on results incl. tables
Immobilization Rates in the Definitive Test after 24 and 48 hours of Exposure
(n = 20, divided into 4 replicates with 5 daphnids each)
Diglycerol diisostearate Nominal Loading Rate [mg/L] |
IMMOBILIZATION [%] |
|||||||||
24 h |
48 h |
|||||||||
Replicates |
Replicates |
|||||||||
1. |
2. |
3. |
4. |
MV |
1. |
2. |
3. |
4. |
MV |
|
100 |
60 |
40 |
20 |
60 |
45 |
80 |
100 |
80 |
80 |
85 |
50.0 |
0 |
20 |
20 |
0 |
10 |
20 |
40 |
80 |
40 |
45 |
25.0 |
0 |
0 |
0 |
0 |
0 |
20 |
20 |
20 |
40 |
25 |
12.5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6.25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the nominal loading rates of the test item Diglycerol diisostearate, the NOELR after 48 h was 12.5 mg/L.. This loading rate is above water solubility based on TOC measurements (see EP Summary Aquatic toxicity). This no hazards were identified up to the water solubility. Effects observed at higher loading rates are most likely effects related inhibition of filtration by the micro droplet of the test emulsion. This assumption is backed by the fact that no toxicity is observed in acute tests of fish and algae up to loading rates of 100 mg/L respectively 250 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.
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.