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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 231-185-8 | CAS number: 7443-25-6
- 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:
- 2016-2017
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 126 “Short Guidance on the threshold approach for acute fish toxicity"
- Version / remarks:
- 2010
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Analytical determination
Analytical evaluation of the test concentration of the test substance was carried out after 0 h and 72 h and corresponding 24 h aged test media after 24 and 96 h via UPLC on a reversed phase column using external standard calibration. - Vehicle:
- no
- Details on test solutions:
- Test concentration
2.00 mg/L was tested as a threshold concentration in a limit test.
The selection of the test concentration was based on the derivation of a threshold concentration (TC) from the results of an alga toxicity test (EYC50 (0-72 h) = 1.11 (0.816 – 1.47) mg/L), based on nominal concentrations of the test item (SCHEERBAUM, 2016) and of an acute daphnia toxicity test (EC50 (0-48 h) = 1.68 mg/L) provided by the sponsor.
Preparation of the test medium
An appropriate amount of the test item was weighed and transferred to an aquaria filled with an appropriate volume of the dilution water. The test media was mixed with an ultraturrax (1 min with 17000 rpm, afterwards 45 min with 8500 rpm). This procedure was repeated for each renewal.
Control
7 fish in dilution water (without test item) were tested under the same test conditions as the test replicates. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: All fish used in the test were gained at NOACK LABORATORIEN from a single brood stock. (supplier: Umweltbundesamt, Schichauweg 58, D-12307 Berlin)
- Length at study end (length definition, mean, range and SD): Average body length: 2.74 cm
- Weight at study end (mean and range, SD): Average body weight: 0.284 g
- Method of breeding:Holding was performed at the test facility at 23 +/- 2 °C and diffuse light (0.1 - 10 µmol photons • m-2 • s-1, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value. No disease treatments were administered throughout holding and testing. Food was provided 3 times per week. The amount of food was 4 % of the fish body weight per feeding day. The test fish were not fed 24 h before the test started.
- Feeding during test: No feeding during test
ACCLIMATION
- Acclimation period: Zebrafish with at least 12 days of acclimatisation and mortality < 5 % within these days before the study starts were used in the test.
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: 4 % of the fish body weight per feeding day. The test fish were not fed 24 h before the test started. Food: Sera Vipan; SERA GMBH, D-52518 Heinsberg
- Feeding frequency: 3 times per week.
- Health during acclimation (any mortality observed): No mortality observed, no disease treatments were administered throughout holding and testing.
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- Total Hardness at day 0: 71 mg/L
- Test temperature:
- Please refer to "Any other information on materials and methods"
- pH:
- Please refer to "Any other information on materials and methods"
- Dissolved oxygen:
- Please refer to "Any other information on materials and methods"
- Salinity:
- Not measured, freshwater
- Nominal and measured concentrations:
- Please refer to "Any other information on materials and methods incl. tables"
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Type (delete if not applicable): open, loosely covered by glass plates
- Material, size, headspace, fill volume: Glass aquaria of 13 L were used, filled with 10 L of dilution water (dimensions: 25.5/18/28 cm, depth of water: 20 cm), and covered with glass plates.
- Aeration: The test vessels were gently aerated during exposure.
- Renewal rate of test solution (frequency/flow rate): A semi-static test with daily renewal of the test media was performed.
- Control: 7 fish in dilution water (without test item) were tested under the same test conditions as the test replicates
- Reference item: No reference item is recommended for this test according to the guideline.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control and pH-control (replicates): 1
- Biomass loading rate: 0.199 g fish per L test solution
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin was used for holding and testing. The water was filtered on activated charcoal and aerated for at least 24 h to remove possible chlorine.
Nominal water parameters:
Total hardness: 10 - 250 mg CaCO3/L
pH-value: 6.0 - 8.5
- Culture medium different from test medium: no
- Intervals of water quality measurement:pH-value, temperature and oxygen saturation were measured in all test vessels every 24 hours.
Total hardness of the water was determined at the beginning out of the control. During the test the water temperature was recorded continuously once per hour with a data logger. The light intensity on the surface of the test aquaria was measured at the start of the exposure.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: A photoperiod of 16 h light / 8 h dark corresponding to natural daylight hours occurred during the course of the study.
- Light intensity: 10 - 100 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered dead if there was no visible movement (e.g. gill covers movement) and if touching of the caudal peduncle produced no reaction. Records were kept of visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.). Observations were made after 2, 24, 48, 72 and 96 h.
TEST CONCENTRATIONS
- Range finding study: None - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1.23 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1.23 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 1.23 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1.23 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 1.23 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: Not observed
- Mortality of control: 0%
- Other adverse effects control: Not observed
- Abnormal responses: Not observed
The environmental conditions (pH-value, temperature, O2saturation) were determined to be within the acceptable limits. The continuous measuring of water temperature was in the valid range of 23 ± 2 °C. The measured light intensity was in the given range of 10 – 100 Lux(mean value 82 Lux). - Results with reference substance (positive control):
- No reference substance tested
- Reported statistics and error estimates:
- Evaluation
The LC0 after 96 h was determined directly from the raw data of the limit concentration. LC50-values do not have to be calculated in a limit test.
Software
All data were computer-generated and rounded for presentation from the full derived data. Consequently, if calculated manually based on the given data minor variations may occur from these figures. - Sublethal observations / clinical signs:
Biological Data
All effect levels are given based on the geometric mean measured test item concentration.
The LC0after 96 hours was ≥1.23 mg/L.
Observations in the Test Vessels
Geometric mean measured test item concentration
[mg/L]Effect *
Number of fish effected at observation time [hours]
2
24
48
72
96
1.23
(1)
7/7
7/7
7/7
7/7
7/7
Control
(1)
7/7
7/7
7/7
7/7
7/7
*) The numbers in brackets correspond to the following observations:
(1) = Normal behaviour
Cumulative Mortality [%] in the Test Vessels
Geometric mean measured concentration
[mg/L]
Cumulative mortality at observation time [hours]
2
24
48
72
96
1.23
0
0
0
0
0
Control
0
0
0
0
0
- Validity criteria fulfilled:
- yes
- Conclusions:
- All effect levels are given based on the geometric mean measured test item concentration. The geometric mean measured test item concentration of 1.23 mg/L was found to have no effect on the vitality of zebrafish.
In conclusion, the LC0 corresponds to the geometric mean measured test item concentration ≥ 1.23 mg/L. The LC50 and the LC100 correspond to the geometric mean measured test item concentration > 1.23 mg/L. - Executive summary:
The acute toxicity of the test item to fish (zebrafish) was determined according to the OECD Guideline for Testing of Chemicals No. 203 (1992) from 2016-04-04 to 2017-01-18 at the test facility with the definitive exposure phase from 2016-12-19 to 2016-12-23.
A nominal test item concentration of 2.00 mg/L (corresponding to a geometric mean measured test item concentration of 1.23 mg/L) was tested as a threshold concentration in a limit test under semi-static conditions.The test had a duration of 96 hours. 7 test organisms were exposed to the limit concentration and the control, respectively. The water quality parameters pH-value, temperature and oxygen saturation, measured after 0, 24, 48, 72 and 96 h, were determined to be within the acceptable limits.
The concentration of the test item in the limit concentration and in the control was analytically verified by UPLC analysis in the freshly prepared media after 0 and 72 hours and in the corresponding 24 hours aged media after 24 and 96 hours. The measured concentrations of the test item in freshly prepared media after 0 and 72 hours of exposure were 58 and 74 % of the nominal values. Corresponding 24 h aged test media showed measured concentrations of 50 to 66 % of the nominal values. Therefore all effect levels given were based on the geometric mean measured test item concentration.
No effect on the test organism was observed at the geometric mean measured test item concentration of 1.23 mg/L after 96 hours. Therefore, the LC0 corresponds to ≥ 1.23 mg/L. The NOEC corresponds to ≥1.23 mg/L and the LOEC corresponds to > 1.23 mg/L.
At the geometric mean measured test item concentration of 1.23 mg/L of the test item, no effects on vitality were observed in Danio rerio. The LC0 corresponds to a geometric mean measured test item concentration of ≥ 1.23 mg/L.
Reference
Description of key information
96-LC50 (Danio rerio) > 1.23 mg/L (geom. mean measured, OECD 203, 2017)
Note: A key value was inserted in order to enable the application of the PNEC calculator. The inserted concentration is higher than the effect concentration used as basis for the PNEC derivation (i.e. 48h-EC50 (Daphnia magna, immobilisation) = 1.68 mg/L) and therefore does not bias the PNEC calculation performed by the PNEC calculator. The nominal test concentration used in the fish acute toxicity test was taken as surrogate (2 mg/L), because the measured concentration -- with no mortality observed -- was 1.23 mg/L and thus lower than the actual effect concentration used as basis for the PNEC calculation (i.e. 1.68 mg/L).
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 2 mg/L
Additional information
In a reliable key study, acute toxicity of the submission substance to fish (zebrafish) was determined according to the OECD 203 (1992) and in compliance with GLP (RL1). A nominal test concentration of 2.00 mg/L was tested as a threshold concentration in a limit test under semi-static conditions during 96 hours. A control was run in parallel. The test concentration and control were analytically verified by UPLC analysis. Effect levels given were based on the geometric mean measured test item concentration. No mortality or sublethal effects were observed in neither treatment group nor control during exposure. The derived effect concentrations were therefore: 96h-LC50 > 1.23 mg/L, 96h-NOEC > 1.23 mg/L. The study was considered reliable and adequate for the environmental hazard assessment for aquatic organisms.
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.