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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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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
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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)
- Deviations:
- yes
- Remarks:
- (the temperature varied by ± 1.25°C during the study, thus being slightly above the accepted variation. However, this was considered not to have affected either the integrity or validity of the study.)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- yes
- Remarks:
- (the temperature varied by ± 1.25°C during the study, thus being slightly above the accepted variation. However, this was considered not to have affected either the integrity or validity of the study.)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: nominal 100 mg/L and control
- Sampling intervals: start and end of the renewal periods
- Sampling method: two samples (50 mL) were taken from each vessel of the freshly prepared (0 and 72 hours) and expired (24 and 96 hours) control and test media.
- Sample storage conditions before analysis: no storage prior to analysis - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fractions (WAFs)
In duplicate, the test substance was added to dilution water (dechlorinated and softened tap water) in an aspirator, and then made up to volume (30 L) whilst magnetically stirring. The bulk preparation was stirred for approximately 24 hours in the dark and then left to stand for approximately 24 hours in the dark. An aliquot (21 L) of the mid-vessel content was syphoned into a fish tank (the first litre of medium having been discarded), to give a 20 L aliquot of Water Accommodated Fraction (WAF) which was used as test medium with a nominal loading rate of 100 mg/L. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: rainbow trout
- Source:commercial fish farm in the UK
- Length at study initiation: 6.3-7.8 cm
- Weight at study initiation: 3.52 g (mean wet weight)
- Feeding during test: none
ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: commercial fish food (TROUW (UK) Ltd. Nutra Fry 02); amount equivalent to 1% of the total wet-weight of fish in the holding tank; no food was given during the 24-hour period immediately before exposure.
- Health during acclimation: no mortality, no medication - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- control: 153 mg/L as CaCO3
treatment: 140mg/L as CaCO3 - Test temperature:
- 13.45°C ± 1.25°C (continuously monitored in one control and one treatment vessel).
Although the temperature was slightly outside the specification of ± 1°C during the study this deviation from guidelines was considered not to have affected either the integrity or validity of the study. - pH:
- 7.4-8.0
- Dissolved oxygen:
- 80-105% air saturation value
- Nominal and measured concentrations:
- nominal loading rate: 100 mg test material/L
mean measured TOC levels in fresh media: 1.5 mgC/L
mean measured TOC levels in expired media (24 h): 0.85-0.99 mgC/L
overall geometric mean value: 1.2 mgC/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass aquaria, containing 20 litres of medium
- Type: open
- Aeration: yes
- Renewal rate of test solution: daily
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.88 g body weight/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water, dechlorinated and softened by passage through a water purification system consisting of activated carbon filter, water softener and reverse osmosis treatment.
Total organic carbon: 1.1 mg C/L
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light : 8 hours dark with periods of subdued lighting at the beginning and end of each light phase
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and sub-lethal effects; recorded at approx. 2, 4, 24, 48, 72 and 96 hours
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study
- Test concentrations: nominal loading rates 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: no mortality or treatment-related effects were noted after 96 hours - Reference substance (positive control):
- not required
- Key result
- 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: results are expressed in terms of loading rates
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality and sub-lethal effects
- Remarks on result:
- other: results are expressed in terms of loading rates
- Details on results:
- - Other biological observations: none
- Mortality of control: zero
- Other adverse effects control: none
The test medium was a grey hazy emulsion. - Reported statistics and error estimates:
- The “no observed effect loading rate” (NOELR) was derived by direct inspection of the data for lethal and sub-lethal effects. An incidence rate of more than one fish out of ten was considered to be significant.
- Validity criteria fulfilled:
- yes
- Remarks:
- mortality of control animals <10%; concentration of dissolved oxygen in all test vessels >60% saturation
Reference
Description of key information
96-h LL50 (based on loading rates) >100 mg/L for Oncorhynchus mykiss (OECD TG 203, EU C.1)
Key value for chemical safety assessment
Additional information
The results indicate that the test material is not toxic to fish up to the limits of its water solubility (<1 mg/L) 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.
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