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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:
- 27 Nov - 01 Dec 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Analytical method was not sensitive enough to detect test item at limit loading rate.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control and 100 mg/L
- Sampling method: Samples were taken at test start and end. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The weighed test sample (0.28 g) and dilution water (2.8 L) were mixed to prepare the nominal concentration of 100 mg/L. The solution was stirred with a magnetic stirrer für 48 h to prepare the test solution.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Precipitate was recorded at the exposure vessel at test start and test end. Particles were floating on top of the water layer.
- Appearance of test solutions: Test solution at start: white, at the end: colorless and clear - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: medaka
- Source: CERI Kurume (in-laboratory production)
- Length at study initiation (length definition, mean, range and SD): 2.0 ± 1.0 cm
- Weight at study initiation (mean and range, SD): 0.14 ± 0.02 g
ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: Feed of Medaka fry for education (KYORIN); Amount corresponding to 3% of body weight
- Feeding frequency during acclimation: daily (fish were not fed 24 h before test initiation)
- Health during acclimation (any mortality observed): 0%; no external medication was provided
FEEDING DURING TEST
- None - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Test temperature:
- 23.2 - 23.9 °C
- pH:
- 7.8 - 8.0
- Dissolved oxygen:
- 8.3 - 8.7 mg/L
- Nominal and measured concentrations:
- nominal: control, 100 mg/L
measured: < LOD for control and limit concentration - Details on test conditions:
- TEST SYSTEM
- Test vessel: 3 L glass tank filled with 2.8 L of test medium (diameter: 16 cm, depth: 16 cm) stored in a temperature controlled water bath
- Type: covered with a transparent plastic lid
- Aeration: yes, gentle aeration
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water, aerated sufficiently and temperature-controlled
- Total organic carbon: < 0.5 mg/L
- Particulate matter: < 1 mg/L
- Pesticides: < LOQ
- Chlorine: < LOQ
- Alkalinity: 36 mg/L
- Culture medium different from test medium: same as test
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h darkness
- Light intensity: room light
EFFECT PARAMETERS MEASURED
- Mortality and visible abnormality were observed after 3, 24, 48, 72 and 96 h after the start of exposure.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable, limit test
- Range finding study
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality was observed after 96 h. - Reference substance (positive control):
- yes
- Remarks:
- Copper (Il) sulfate pentahydrate was periodically tested.
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: 0%
- Abnormal responses: No abnormal response was observed in the exposure level and control during exposure.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The exposure solutions were colorless and clear with floating particles on the surface. The solution in the control was colorless and clear. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- LC50 (96 h): 0.33 mg/L (standard deviation: 0.14 - 0.90 mg/L)
- Other: Study was performed from 13-17 Nov 2017 - Sublethal observations / clinical signs:
Table 1: Validity criteria for OECD 203.
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
8.3 - 8.7 mg/L
(saturation level: 8.26 - 8.58 mg/L)yes
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Analytical method is not considered to be appropriate.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control, 1000 mg/L
- Sampling method: Water samples were taken from the middle of the test chamber by pipetting approx. 20 mL into a screw-neck glass bottle at study start, and after 48 and 96 h. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was weighed into a beaker. Water for dilution was added, the mixture was homogenized using an Ultra-Turrax and poured into the chamber under stirring with a glass rod. The chamber contents were then stirred for approximately 30 min with a KPG-stirrer and a glass rod.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): The tested concentration showed a turbidity. Additionally substance deposits at the water surface and on the bottom of the test chamber were observed. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Source: Charles River Aquatics, Someren, Netherlands (date of hatching: 15 Dec 1995; date of delivery: 13 Mar 1996)
- Length at study initiation (length definition, mean, range and SD): 2.7 - 3.0 cm (mean: 2.8 cm)
ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): 22 ± 1 °C, oxygen content >= 80% of the saturation value, 12 h light daily
- Type and amount of food during acclimation: commercial fish food (Tetra Min, Tetra Werke, Melle)
- Feeding frequency during acclimation: twice daily ad libitum
FEEDING DURING TEST
- None - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Test temperature:
- 21.6 - 21.8 °C (test concentration)
21.2 - 21.9 °C (control) - pH:
- 7.8 - 8.1 (test concentration)
8.0 - 8.2 (control) - Dissolved oxygen:
- 6.9 - 9.5 mg/L (test concentration)
8.0 - 9.9 mg/L (control) - Nominal and measured concentrations:
- nominal: control, 1000 mg/L
measured: < 1 (control), 342 mg/L (geometric mean; 1000 mg/L) - Details on test conditions:
- TEST SYSTEM
- Test vessel: The test chambers, which were calibrated to 10 L, were made of glass (length 30 cm, width 22 cm, height 24 cm) and stood in a water bath with a plexiglas viewing panel.
- Aeration: no
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water, composition according to ISO/DIS 7346/1 was used as water for dilution.
- Hardness: 2.3 - 2.5 mmol Ca2+ + Mg2+/L
- Culture medium different from test medium: same as test
- Intervals of water quality measurement: Water parameters were measured regularly.
OTHER TEST CONDITIONS
- Photoperiod: 12 h light / 12 h darkness
- Light intensity: 700 lux
EFFECT PARAMETERS MEASURED
- Mortality was recorded after 3, 6, 24, 48, 72 and 96 h - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Other biological observations: Recording of symptoms was disturbed because of the turbidity of the test water until 24 h after study start. Ouring this first 24 h the fish showed slight, reversible symptoms as swimming posture tail-heavy and projecting opercula.
- Mortality of control: 0% - Sublethal observations / clinical signs:
Table 1: Validity criteria for OECD 203.
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
6.9 - 9.5 mg/L (test concentration)
8.0 - 9.9 mgL (control)
8.8 mg/L (=100% saturation)
yes
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Referenceopen allclose all
Description of key information
LL50 (96 h) > 100 mg/L (nominal, OECD 203)
Key value for chemical safety assessment
Additional information
Two experimental studies are available investigating short term
toxicity of Fatty acids C16-18 (even numbered), oligoesters with sucrose
to freshwater fish.
The key study was performed according to OECD 203 (GLP) with Oryzias
latipes. A limit loading rate of 100 mg/L was tested and mortality of
fish was determined after 96 h. The actual concentration in the test
vessels was tried to analyze using HPLC. However, the analytical method
was not sensitive enough (limit of detection: 0.505 mg/L) to detect the
substance in test solutions. This result reflects the very low water
solubility of the test item. After 96 h no mortality was recorded and
the LL50 was derived to be > 100 mg/L (nominal).
In the supporting study Danio rerio was exposed to the test item for 96
h at a limit concentration of 1000 mg/L. The study was performed
according to OECD 203 (GLP). The test item was directly added to the
test vessels without any further processing step (e.g. filtration). HPLC
analysis of the test item concentration in test medium resulted in a
geometric mean measured concentration of 342 mg/L. This result is
unexpectedly high and does not fit to the very low water solubility of
the test item which was reported to be < 0.509 mg/L. Thus, the applied
analytical method is not considered to be robust and the results are
based on the nominal concentration. After 96 h no mortality was recorded
and a LC50 of > 1000 mg/L was derived.
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