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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
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:
- key study
- 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 quantitation.
- 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:
- 2009
- 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
- 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 (ISO-medium) 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:
- 20.6 - 22.6°C
- pH:
- 7.59 – 8.32
- Dissolved oxygen:
- 66 – 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: 2.5 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 = 0.77 g fish/L, 100 mg/L test concentration = 0.69 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 - 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
1.92
0.27
0.77
100.0 mg/L
nominal loading rate1.72
0.25
0.69
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
2.6
2.4
2.7
2.6
2.6
2.5
2.6
100.0
2.4
2.5
2.5
2.6
2.7
2.5
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
66 – 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification document provided in IUCLID section 13.
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 2 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: test mat. WAF
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: source, RA-A, CAS 91050-80-5, Emery, 2008, Cyprinodon variegatus, 96h
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 2 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: test mat. WAF
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: source, RA-A, CAS 91050-80-5, Emery, 2008, Cyprinodon variegatus, 96h
- Conclusions:
- No effects are expected up to the limit of water solubility.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Nov - 10 Nov 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given (comparable to guidelines/standards)
- Qualifier:
- according to guideline
- Guideline:
- other: OSPARCOM (2005-11) protocol for a fish acute toxicity test
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Principles of method if other than guideline:
- Test methods were consistent with OECD 203 guideline as adapted by OSPARCOM (2005-11) for marine testing of offshore chemicals.
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test materials were characterised following Opus Plus SOP 402, where a 1000 mg/L stock was prepared and stirred for approximately 3 hours. This preparation was then left undisturbed for approximately one hour before behaviour in seawater classification was assigned and subsequently prepared for testing according to Opus Plus SOP 403. Poorly soluble materials were prepared as water accommodated fractions (WAFs). Solutions of 4 litres were prepared, stirred for 20 hours and then siphoned into the test vessels.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): floating or settled particles at 1000 mg/L in seawater - Test organisms (species):
- Cyprinodon variegatus
- Details on test organisms:
- TEST ORGANISM
- Common name: Sheepshead minnow, killifish
- Source: reared and maintained at Opus Plus Ltd
- Age at study initiation (mean and range, SD):
- Length at study initiation: 1.5-2.5 cm
ACCLIMATION
- Acclimation conditions: Sheepshead minnow were held under flow-through conditions in 50 litre capacity glass tanks, containing 1 µm filtered ultra-violet treated seawater and supplied with gentle aeration.
- Type and amount of food: food in flake form ad libitum
- Feeding frequency: at least twice daily - Test type:
- semi-static
- Water media type:
- saltwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Test temperature:
- 19.7 - 20.4 °C
- pH:
- 7.80 - 8.19 (control)
7.89 - 8.11 - Dissolved oxygen:
- 94 - 97%
- Salinity:
- 34 - 36‰
- Nominal and measured concentrations:
- 2300 mg/L (nominal, WAF)
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 15 litre capacity glass tanks containing 3 litres of test media
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): replacement of media after 48h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural local seawater is pumped to holding tanks from Scapa Flow, Orkney. The treatment process was: sand filtered to remove particulate, filtered to 1 µm, heated to 16 ºC, UV treated, degassed and held at a quantity of 3000 to 5000 litres. The water is constantly pumped through the system and trickle replenished as the water is used.
OTHER TEST CONDITIONS
- Adjustment of pH: yes
TEST CONCENTRATIONS
- Range finding study: Range-finding tests were conducted under static conditions over 96h with five animals exposed per concentration (one replicate); no data on concentrations provided
- Results used to determine the conditions for the definitive study: The test concentration is based on the LC/EC50 of the test material between most sensitive species Skeletonema costatum and Acartia tonsa in other tests. The algal species was noted to be the more sensitive from allied studies. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 2 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: test mat. WAF
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 2 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: test mat. WAF
- Basis for effect:
- mortality (fish)
- Reported statistics and error estimates:
- Mortalities were determined in each vessel every 24h period. The number of dead organisms were expressed as a proportion of the total number exposed. Where sufficient response was observed for Range-finding and definitive tests, the 24h, 48h, 72h and 96h LC50values, 96h LC90and 96h NOEC values were calculated from the proportional response data using an appropriate method (ToxCalc V5, Tidepool Scientific Software).
Referenceopen allclose all
Description of key information
LL50 (96 h) > 100 mg/L (nominal, Danio rerio)
LL50 (96 h) > 2300 mg/L (nominal, Cyprinodon variegatus); read-across
Key value for chemical safety assessment
Additional information
There is one study available in which the short-term toxicity of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers to fish was assessed.
The GLP study was performed according to OECD 203 using Danio rerio as test organism. A limit test with a nominal test concentration of 100 mg/L was conducted in a semi-static exposure regime. This test concentration was prepared as Water Accommodated Fraction (WAF). The test concentration was analytically determined at the start and at the end of the first and at the last renewal periods. 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. No effects were observed after 96 h for the tested concentration. Therefore, a LL50 (96 h) of > 100 mg/L (nominal) was derived.
This result is supported with a study for the structurally and chemically related source substance Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5). This read-across was performed in accordance with Regulation (EC) No 1907/2006 Annex XI, section 1.5 in order to fulfill the data requirements for this substance. The source substance is characterized by comparable chemical structure and similar physico-chemical properties and is therefore considered as suitable representative for the assessment of the short-term toxicity of the target substance to fish. A read-across justification in provided in IUCLID section 13.
The GLP study conducted with the source substance Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5) was performed according to “OSPARCOM (2005-11) protocol for a fish acute toxicity test”, equivalent to OECD 203, using the marine fish Cyprinodon variegatus. A limit test with a nominal test concentration of 2300 mg/L was conducted in a semi-static exposure regime. This test concentration was prepared as Water Accommodated Fraction (WAF). No mortality was observed after 96 h for the tested concentration. Therefore, a LL50 (96 h) of > 2300 mg/L (nominal) was derived.
Based on the available results from the target substance and a structurally related read-across substance (in accordance with 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 target substance Fatty acids, C16-18 (even numbered), esters with glycerol oligomers is not expected to show toxicity to fish up to the limit of its water solubility (91.9 µg/L).
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