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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 09 - 13 Mar 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Measured concentrations were below the limit of quantification.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Version / remarks:
- 1996
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 2017
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National Institute of Pharmacy and Nutrition, Budapest, Hungary (date of issue: 03 August 2018)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and 100 mg/L nominal loading rate WAF was analytically determined at the start and at the end of the first and at the last renewal periods.
- Sampling method: Four samples were taken (2 x 2 x ~15 mL) from the control and at the applied test concentration level at the beginning and at the end of the renewal periods
- Sample storage conditions before analysis: Samples were frozen and kept approximately at -20 °C at the Test Facility. One set of the samples was sent to the Test Site for analysis and one set was retained as a back-up at the Test Facility, if required for any confirmatory analyses. - Vehicle:
- no
- Details on test solutions:
- - Method: The test item is poorly soluble in water, so test solutions were prepared using a saturated solution method (nominal loading rate of 100 mg/L, water accommodated fraction, WAF) according to the Guidance Document on Aqueous-Phase Aquatic Toxicity Testing of Difficult Test Chemicals, OECD No. 23. The saturated test item solution was prepared by dispersing/dissolving the amount of test item into the test medium (aquarium water) two days before the start of the study. This solution was shaken for about 24 hours at approximately 30 °C and then equilibrated for about 24 hours at approximately 20°C. The non-dissolved test material was removed by filtration through a fine (0.22 μm) filter. Prior to treatment of each renewal period, test item solutions were prepared by the method described above.
- Controls: yes, dilution water (circulated and filtered) - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: István Szent University, 2100 Gödöllő, Páter Károly u. 1, Hungary
- Length at study initiation (length definition, mean, range and SD): 2.4 – 2.7 cm
- Weight at study initiation (mean and range, SD): calculated mean weight of 1 fish = 0.25 - 0.27 g
- Method of breeding: Fish were bred in a well-known fish farm, under disease- and parasite-controlled conditions. Fish were observed during the acclimatisation and test periods, the fish were healthy. There was no mortality of the population for seven days before the test.
ACCLIMATION
- Acclimation period: more than 12 days
FEEDING DURING TEST
- Food type: No - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 186 mg/L (as CaCO3)
- Test temperature:
- 21.0 - 22.5 °C
- pH:
- 7.78 – 8.34
- Dissolved oxygen:
- 72 – 100% of the air saturation value
- Nominal and measured concentrations:
- - Nominal concentration: 100 mg/L nominal loading rate WAF
- Measured concentration 0 h (new): < LOQ
- Measured concentration 72 h (new): < LOQ
- Measured concentration 24 h (old): < LOQ
- Measured concentration 96 h (old): < LOQ - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquarium
- Fill volume: 5 L
- Renewal rate of test solution (frequency/flow rate): 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: Control = 0.36 g fish/L, 100 mg/L test concentration = 0.38 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: circulated and filtered water
- Intervals of water quality measurement: The water temperature, oxygen concentration and pH were measured at the beginning and at the end of the renewal periods during the experiment in each test aquarium.
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality or any sub-lethal effects were observed at 3, 6, 24, 48, 72 and 96 hours.
TEST CONCENTRATIONS
- Range finding study: Yes
- Test concentrations: 0.1, 1, 10, 100 mg/L nominal loading rate WAF
- Results used to determine the conditions for the definitive study: No effects in range finding study, NOEC = 100 mg/L nominal loading rate WAF - Reference substance (positive control):
- not required
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- based on nominal loading rate WAF
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- based on nominal loading rate WAF
- Details on results:
- - Behavioural abnormalities: No, there were no clinical signs observed in the fish at any of the concentrations during the experiment.
- Observations on body length and weight: There was no considerable difference observed concerning body weights between the groups. - Reported statistics and error estimates:
- No statistical analysis was performed because of the lack of toxic effects.
- Sublethal observations / clinical signs:
Table 1: Calculation of exposure concentrations
Nominal Loading
rate WAFs
(mg/L)Measured concentrations
1st renewal period (mg/L)Measured concentrations
2nd renewal period (mg/L)start
end
start
end
Control
<LOQ*
<LOQ*
<LOQ*
<LOQ*
100.0
<LOQ*
<LOQ*
<LOQ*
<LOQ*
*0.038 mg/L sample concentration (counting with 50x enrichment and 1.05x dilution during the sample preparation)
Table 2: Cummulative mortality data of danio rerio
Nominal
Loading rate WAF mg/L
Total number of animals
Cummulative mortality of fish
3 h
6 h
24 h
48 h
72 h
96 h
Control
7
0
0
0
0
0
0
100
7
0
0
0
0
0
0
Table 3: Measured and calculated data of bodyweight
Test Group
Measured weight
of 7 fish (g)Calculated mean
weight of 1 fish (g)Loading of testing aquarium
(g fish/L testing liquid)Control
1.79
0.26
0.36
100.0 mg/L
nominal loading rate1.90
0.27
0.38
Table 4: Body length of test fish at mortality or at the end of the test
Loading rate
WAF (mg/L)Body length [cm]
Nominal
Control
2.5
2.7
2.6
2.6
2.7
2.5
2.6
100.0
2.6
2.7
2.5
2.6
2.4
2.7
2.6
Table 5: Validity criteria
Criterion from the guideline
Outcome
Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test
0%
Yes
The dissolved oxygen concentration must have been at least 60 per cent of the air
saturation value throughout the test
72 – 100% air saturation throughout the test
Yes
There must be evidence that the concentration of the substance being tested has been
satisfactorily maintained, and preferably it should be at least 80 per cent of the
nominal concentration throughout the test. If the deviation from the nominal
concentration is greater than 20 per cent, results should be based on the measured
concentration.
The results were based on nominal concentrations, measured concentrations were below the limit of quantitation in this study
No
- Validity criteria fulfilled:
- no
- Remarks:
- See Table 5 at "any other information on results incl. tables".
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Suspensions of the 300 mg test substance were prepared in 3 l drinking water. shaking machine 130 rpm at room temperature for 24 h.
After 24 h the shaking was stopped and the solutions were filtered through paper filters directly into the test vessles used for the test, pH of the test solutions was not justified. The nominal concentration used for the test was 100 mg/l.
- Controls: yes, negative control - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Strain: not applicable
- Source: Aquafarm Ryba, Zeven, Germany
- Age at study initiation (mean and range, SD): not mentioned
- Length at study initiation: approx. 2.4 cm
- Weight at study initiation: not mentioned
- Method of breeding: not mentioned
- Feeding during test: none
ACCLIMATION
- Acclimation period: not mentioned - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- none
- Hardness:
- not mentioned
- Test temperature:
- 22 - 23.4 °C
- pH:
- control: 7.62 - 8.31
test substance: 7.74 - 8.24 - Dissolved oxygen:
- control: 8.0 - 8.3 mg O2/L
test substance: 7.9 - 8.3 mg O2/L - Salinity:
- not mentioned
- Nominal and measured concentrations:
- control / 100 mg/L (nominal)
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 5 L capacity glass tanks
- Aeration: not mentioned
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: not mentioned
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted
- Total organic carbon: not mentioned
- Particulate matter: not mentioned
- Alkalinity: not mentioned
- Ca/mg ratio: not mentioned
- Conductivity: not mentioned
- Culture medium different from test medium: no
- Intervals of water quality measurement: not mentioned
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: day/night-cycle 16 h/8h
- Light intensity: not mentioned
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): 24, 48, 72 and 96 h the test solutions were examined for dead animals. The pH was not adjusted furthermore during the test.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study: not performed - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: not observed
- Observations on body length and weight: no changes in length and body weights compared to the negative controls
- Other biological observations: none
- Mortality of control: 0%
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: test conducted at test concentration above solubility of test substance - Results with reference substance (positive control):
- no reference substance tested
- Reported statistics and error estimates:
- no statisitcs performed
- Sublethal observations / clinical signs:
Table: Mortality (cumulative data)
concentration (nominal)[mg/L] Number of fish Mortality in % 24 h 48 h 72 h 96 h 0 (control) 7 0 0 0 0 100 7 0 0 0 0 - Validity criteria fulfilled:
- yes
- Conclusions:
- Under the present test conditions no toxic effects caused by the test item were observed at a nominal concentration of 100 mg/L exposure medium in a limit test. None of the animals died.
- Executive summary:
In a 96-h acute toxicity study according to OECD 203 and GLP, zebrafish (Danio rerio) were exposed to the test substance (CAS 91744-38-6, Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts) at concentrations of 0 and 100 mg/L nominal (limit test) under semi-static conditions. The 96-h LL50based on mortality was > 100 mg/L. No sublethal effects were observed. Based on the results of this study, the test substance would be classified as non-toxic to Danio rerio.
Although the test substance has a low water solubility and the actual test concentration was not verified, the study is classified as acceptable. In WAF procedure, suspensions of the 300 mg test substance were prepared in 3L drinking water and shaken at room temperature for 24 h. After 24 h the shaking was stopped and the solutions were filtered through paper filters directly into the test vessels used for the test. Therefore it can be concluded that the test substance is not toxic at a loading of 100 mg/L (NOELR = 100 mg/L).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to analogue justification document provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
Referenceopen allclose all
Description of key information
Danio rerio: 96-hour LL50 > 100 mg/L nominal loading WAF (OECD 203, 1992)
Danio rerio: 96-hour LL50 >100 mg/L (OECD 203); read-across
Key value for chemical safety assessment
Additional information
The acute toxicity of Glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7) towards fish was investigated in a 96-h acute toxicity GLP study according to OECD 203 (1992). Zebrafish (Danio rerio) were exposed to the test substance at 0 and 100 mg/L nominal loading rate water accommodated fractions (WAF) (limit test) under semi-static conditions. The 96-h LL50 based on mortality was > 100 mg/L. No sublethal effects were observed. The test item concentration could not be analytically quantified during the whole experiment as all measured concentrations were below the Limit of Quantification (LOQ = 0.038 mg/L). Therefore, all results are expressed as the nominal loading rate WAF.
Additionally, to support the results of the study with the test item in a read-across approach to the structurally and chemically related source substances Glycerides, C16 - 18 (even numbered) mono-, di-, and tri-, hydrogenated, citrates, potassium salt (CAS 917440-38-6), a 96-h acute toxicity GLP study was performed according to OECD 203. Zebrafish (Danio rerio) were exposed to the test substance (CAS 91744-38-6, Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts) at concentrations of 0 and 100 mg/L nominal (limit test) under semi-static conditions. The 96-h LL50 based on mortality was > 100 mg/L. No sublethal effects were observed.
Based on the results of both studies, no acute effects up to the water solubility (129 µg/L) towards fish are expected upon exposure with the target substance Glycerides, C16 - 18, mono- and di-, citrates.
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.