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EC number: 422-120-6 | CAS number: 166432-53-7
- 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:
- 16-08-2000 to 29-09-2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met with acceptable deviations.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- No positive control conducted as part of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- yes
- Remarks:
- No positive control conducted as part of the study.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: February 2000 ; signature: April 2000
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0 (control), 0.600, 1.23, 2.19, 4.11, 7.70 mg/L analytically confirmed initial concentration
Time Weighted Mean Measured equivalent concentrations: 0 (control), of 0.255, 0.430, 0.747, 1.34 and 2.41 mg/L (measured ; based on measured concentrations in the definitive test taken at 24 hour intervals in old/fresh media respectively pre-/post- renewal)
- Sampling method: Water samples were taken from the control and all surviving test groups at 0 (fresh media); 24, 48, 72 (old and fresh media) and 96 (old media) hours for quantitative analysis. Where possible all samples were prepared for analysis on the day of sampling. Duplicate samples were taken and stored frozen (approximately -20°C) for further analysis if necessary.
- Sample storage conditions before analysis: See above. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct dissolution of test item in culture medium to prepare stock; serial dilution of stock to prepare test media. The test concentrations used in the definitive study were prepared by adding an amount of test item to the vortex created in a volume of water to give an initial dispersion at a concentration of 1000 mg/L. Stirring periods of 23 hours and 95 hours were employed, both with 1 hour standing periods. Vortex depths of 5% and 25% were used for both stirring periods and samples taken by mid-depth siphon for chemical analysis. This work showed that increasing the stirring period and/or the vortex depth did not significantly increase the measured test concentration of the saturated solution. Therefore, a stirring period of 23 hours with a 5% vortex depth was used for all further stirring work. To ensure that saturated solutions prepared by this method contained only dissolved test item, samples were removed by mid-depth siphon and analysed with and without filtration (0.2 micron
filters). A sample prepared as above was also subject to centrifugation at approximately 17000 G for periods of 10, 20 and 30 minutes prior to chemical analysis. Based on the results of the range-finding study the test item solutions for the definitive study were prepared by stirring an excess of test item (equivalent to 1000 mg/L) in dechlorinated tap water for a period of time and then removing the aqueous phase by siphon to produce a saturated solution with a measured concentration of 7. 7 mg/L. This saturated solution was then further diluted, as necessary, to produce the remaining measured test concentrations of 0.600, 1.23, 2.19 and 4.11 mg/L.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable.
- Concentration of vehicle in test medium (stock solution and final test solution): Not applicable.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No precipitate reported. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow Trout (Oncorhynchus mykiss)
- Strain: Not reported.
- Source: Recognised supplier (listed in full study report).
- Age at study initiation (mean and range, SD): Not reported.
- Length at study initiation (length definition, mean, range and SD): 4.3 cm (SD = 0.2)
- Weight at study initiation (mean and range, SD): 1.04 g (SD = 0.16) i.e. ca. 0.52 g bw/L loading rate
- Method of breeding: Not reported.
- Maintenance of the brood fish: Not reported.
ACCLIMATION
- Acclimation period: 12 days.
- Acclimation conditions (same as test or not): Yes.
- Type and amount of food during acclimation: certified pelleted diet
- Feeding frequency during acclimation: daily (until 24 hours prior to test).
- Health during acclimation (any mortality observed): < 1% mortality in 7 days pre-test
QUARANTINE (wild caught)
- Duration: Not applicable.
- Health/mortality: Not applicable.
FEEDING DURING TEST
- Food type: Not applicable.
- Amount: Not applicable.
- Frequency: Not applicable. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Remarks on exposure duration:
- According to OECD TG 203 guidelines.
- Post exposure observation period:
- none.
- Hardness:
- ca. 100 mg/L (expressed as CaCO3)
- Test temperature:
- 14 ºC to 14.5 ºC
- pH:
- 7.7 fresh media); 7.8-8.0 (expired media)
- Dissolved oxygen:
- 8.8-8.9 mgO2/L (fresh media); 8.2-8.4 mgO2/L (expired media)
- Salinity:
- not applicable.
- Nominal and measured concentrations:
- Concentrations: 0 (control), 0.600, 1.23, 2.19, 4.11, 7.70 mg/L analytically confirmed initial concentration
Time Weighted Mean Measured equivalent concentrations: 0 (control), of 0.255, 0.430, 0.747, 1.34 and 2.41 mg/L (measured ; based on measured concentrations in the definitive test taken at 24 hour intervals in old/fresh media respectively pre-/post- renewal) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 20 L for test and control vessels, glass fibre
- Type (delete if not applicable): open, covered to reduce evaporation
- Material, size, headspace, fill volume: 20L fill volume test media per test vessel
- Aeration: Yes.
- Renewal rate of test solution (frequency): 24 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: 0.52 g/L (mean)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Drinking water; chlorine removed by activated carbon filtration and partial softening (DI).
- Total organic carbon: Not reported
- Particulate matter: Not reported
- Metals: Not reported
- Pesticides: Not reported
- Chlorine: Not reported
- Alkalinity: Not reported
- Ca/mg ratio: Not reported
- Conductivity: Not reported
- Culture medium different from test medium: No.
- Intervals of water quality measurement: 24 hours.
OTHER TEST CONDITIONS
- Adjustment of pH: No.
- Photoperiod: 16 h light / 8 h darkness
- Light intensity: Not reported.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and visible abnormality recorded at 3 h, 24 h, 48 h, 72 h and 96 h.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable. Concentrations justified from the results of the range finding study.
- Range finding study: yes (semi-static) ; 3 organisms per concentration.
- Test concentrations: blank control, 0.12, 1.2 and 12 mg/L nominal
- Results used to determine the conditions for the definitive study: Yes. No mortalities at 0 (control), 0.12 or 1.2 mg/L. Complete mortality at 24 hours in 12 mg/L. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.6 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: (95% CL: 1.4 - 1.9 mg/L) ; time weighted mean measured concentrations
- Details on results:
- - Behavioural abnormalities: See table 1 and 2
- Observations on body length and weight: Not reported
- Other biological observations: Not reported
- Mortality of control: 0%
- Other adverse effects control: No abnormalities observed in the control.
- Abnormal responses: increased pigmentation, loss of equilibrium, loss of equilibrium with increased pigmentation, swimming at the bottom, Moribund
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The reason for the decline in test item concentrations exposure period is speculated to be due to adsorption and/or biological factors.
- Effect concentrations exceeding solubility of substance in test medium: Not applicable - Sublethal observations / clinical signs:
Table 1.0 - Cumulative mortality
Time Weighted Mean Measured Concentration (mg/L)
Cumulative mortality (n=10)
Total mortality %
3h
6h
24h
48h
72h
96h
0.00
0
0
0
0
0
0
0
0.255
0
0
0
0
0
0
0
0.430
0
0
0
0
0
0
0
0.747
0
0
0
1
1
1
10
1.34
0
0
7*
10
10
10
100
2.41
10
10
10
10
10
10
100
* the remaining 3 fish were observed as moribund and humanely terminated. Included in 24h LC50 determination as mortality.
Table 2.0 – Sub-lethal effects/responses
Time Weighted Mean Measured Concentration (mg/L)
Sub-lethal effects
Time
3h
6h
24h
48h
72h
96h
0.00
No abnormalities
0.255
No abnormalities
0.430
No abnormalities
0.747
Increased pigmentation
Loss of equilibrium
Loss of equilibrium with increased pigmentation
Swimming at bottom with increased pigmentation
Moribund
4/10
5/10
1/10
8/10
8/10
1/10
9/10
1/10
3/9
6/9
4/9
4/9
4/9
4/9
1/9
1.34
Loss of equilibrium
Loss of equilibrium with increased pigmentation
Moribund
4/10
6/10
1/10
9/10
3/3**
CM
2.41
loss of equilibrium and gasping, moribund
2/4
2/4**
CM
Where:
** = humanely euthanized and indicated as mortalities
CM = complete mortality
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96 hour LC50 for the test item to Rainbow Trout (Oncorhynchus mykiss) was determined to be 1.6 (C.I. 1.4 - 1.9) mg/L based on time weighted mean measured concentrations.
- Executive summary:
The acute toxicity of the test item to Rainbow Trout (Oncorhynchus mykiss) was determined in a 96 hour semi-static test according to OECD TG 203 and EU Method C.1 guidelines under GLP. Following a preliminary range-finding test, fish were exposed, in groups often, to an aqueous solution of the test item at time-weighted mean measured test concentrations of 0.255, 0.430, 0.747, 1.34 and 2.41 mg/L for a period of 96 hours under semi-static test conditions. Based on the results of the range-finding study the test item solutions for the definitive study were prepared by stirring an excess of test item (equivalent to 1000 mg/L) in dechlorinated tap water for a period of time and then removing the aqueous phase by siphon to produce a saturated solution with a measured concentration of 7. 7 mg/L. This saturated solution was then further diluted, as necessary, to produce the remaining measured test concentrations of 0.600, 1.23, 2.19 and 4.11 mg/L.Chemical analysis of the freshly prepared test media throughout the study showed measured concentrations ranging from 0.646 to 8.24 mg/L for the uncentrifuged samples and from 0.522 to 7.70 mg/L for the centrifuged samples. A marked decline was shown in the measured concentrations of the old or expired test media with values ranging from less than the limit of quantitation (LOQ) to 4.53 mg/L for uncentrifuged samples and less than the LOQ to 4.04 mg/L for the centrifuged samples. The reason for the decline in test item concentrations exposure period is speculated to be due to adsorption and/or biological factors. On this basis the test item was not maintained at ±20% of the initial concentrations therefore the effect levels were estimated based on time weighted mean measured concentrations. Under the conditions of this study, the 96h LC50 was 1.6 (C.I. 1.4 – 1.9) mg/L based on time weighted mean measured concentrations.
Reference
Description of key information
LC50 (fish) = 1.6 (C.I. 1.4 – 1.9) mg/L based on time weighted mean measured concentrations, 96hour, freshwater, OECD TG 203, 2000
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 1.6 mg/L
Additional information
Key study : OECD TG 201, 2000 : The acute toxicity of the test item to Rainbow Trout (Oncorhynchus mykiss) was determined in a 96 hour semi-static test according to OECD TG 203 and EU Method C.1 guidelines under GLP. Following a preliminary range-finding test, fish were exposed, in groups often, to an aqueous solution of the test item at time-weighted mean measured test concentrations of 0.255, 0.430, 0.747, 1.34 and 2.41 mg/L for a period of 96 hours under semi-static test conditions. Based on the results of the range-finding study the test item solutions for the definitive study were prepared by stirring an excess of test item (equivalent to 1000 mg/L) in dechlorinated tap water for a period of time and then removing the aqueous phase by siphon to produce a saturated solution with a measured concentration of 7. 7 mg/L. This saturated solution was then further diluted, as necessary, to produce the remaining measured test concentrations of 0.600, 1.23, 2.19 and 4.11 mg/L.Chemical analysis of the freshly prepared test media throughout the study showed measured concentrations ranging from 0.646 to 8.24 mg/L for the uncentrifuged samples and from 0.522 to 7.70 mg/L for the centrifuged samples. A marked decline was shown in the measured concentrations of the old or expired test media with values ranging from less than the limit of quantitation (LOQ) to 4.53 mg/L for uncentrifuged samples and less than the LOQ to 4.04 mg/L for the centrifuged samples. The reason for the decline in test item concentrations exposure period is speculated to be due to adsorption and/or biological factors. On this basis the test item was not maintained at ±20% of the initial concentrations therefore the effect levels were estimated based on time weighted mean measured concentrations. Under the conditions of this study, the 96h LC50 was 1.6 (C.I. 1.4 – 1.9) mg/L based on time weighted mean measured concentrations.
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