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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 825-571-0 | CAS number: 60428-79-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Duplicate samples for analysis were taken from the single WAF and the control.
Frequency: at t=0 h and t=96 h
Volume: 2.0 mL
Storage: Not applicable, samples were analysed on the day of sampling - Vehicle:
- no
- Details on test solutions:
- The test item was not completely soluble at the loading rate of 100 mg/L. Thus, preparation of the test solution started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to reach the maximum dissolution of the test item in medium. Thereafter, the Water Accommodated Fraction (WAF) was collected by means of filtration through a 0.45 µm membrane filter (Supor®, Pall Corporation) and used as test concentration. The test solution was clear and colorless at the end of the preparation procedure. No correction was made for the purity/composition of the test item.
The method of preparation of the test medium was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.
- Controls: Test medium without test item or other additives - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.
- Length at study initiation (mean and SD): 2.5 ± 0.1 cm
- Weight at study initiation (mean and SD): 0.52 ± 0.09 g
HOLDING / ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: Pelleted fish food (Essence (300-500 µm), Coppens International bv, Helmond, The Netherlands)
- Feeding frequency during acclimation: Daily
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.
FEEDING DURING TEST
No feeding from 24 hours prior to the test and during the total test period - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 1.8 mM (180 mg CaCO3/L)
- Test temperature:
- 20 - 21 °C
- pH:
- 7.7 - 8.1
- Dissolved oxygen:
- ≥ 6.6 mg/L (>60% oxygen saturation)
- Nominal and measured concentrations:
- nominal loading rate: 100 mg/L (WAF)
measured test concentrations: test start: 0.046 mg/L and < LOQ (0.001 mg/L); test end (96 h): < LOQ
The measured concentration of 0.046 mg/L was regarded as not reliable since the solubility limit of the test item has been shown to be < 0.001 mg/L (the LOQ of the analytical method used) during the range-finding test as well as in an acute toxicity study with daphnia and in an algal growth inhibition test (Test Facility Study No. 20148112 and 20148113). - Details on test conditions:
- TEST SYSTEM
- Test vessel: 10-litres all-glass vessels, containing 8 liters of test medium
- Type (delete if not applicable): open
- Aeration: none
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.46 g fish wet weight/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
Composition: CaCl2.2H2O: 211.5 mg/L, MgSO4.7H2O: 88.8 mg/L, NaHCO3: 46.7 mg/L, KCl: 4.2 mg/L.
- Ca/Mg ratio: 4:1
- Culture medium different from test medium: no
- Intervals of water quality measurement:
temperature, dissolved oxygen and pH: daily in all vessels, beginning at the start of the test (day 0)
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hour photoperiod daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality and sub-lethal effects; recorded at 2½, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 to observe for any dead or severely distressed fish.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study
- Test concentrations: WAFs prepared at loading rates of 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality or clinical effects were observed at any of the WAFs during the test period. Therefore, the expected LL50 was above the concentration obtained in a WAF prepared at 100 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- Pentachlorophenol at 0.10, 0.22 and 0.46 mg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- WAF prepared at a loading rate of 100 mg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- other: mortality and sub-lethal effects
- Remarks on result:
- other:
- Remarks:
- WAF prepared at a loading rate of 100 mg/L
- Details on results:
- - Behavioural abnormalities:
- Other biological observations: none; all fish survived and no visible abnormalities were observed.
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- LC50: 0.15 mg/L (95 % confidence interval between 0.10 and 0.22 mg/L)
- Other: historical range: 0.10 – 0.46 mg/L - Reported statistics and error estimates:
- The NOELR and LL50 were determined directly from the raw data.
- Validity criteria fulfilled:
- yes
- Remarks:
- /no mortality of control animals; concentration of dissolved oxygen in all test vessels >60% of the air saturation; test conditions were maintained constant throughout the test
Reference
Description of key information
effect value for carp (Cyprinus carpio), (OECD 203): 96-h LL50: > 100 mg/L (WAF)
Key value for chemical safety assessment
Additional information
LL50 for freshwater fish: > 100 mg/L.
The results indicate that the test material is not toxic to fish up to the limits of its solubility (<1 μg/L in test water) and a NOEC and thus a PNEC cannot be determined.
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.