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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 451-060-3 | CAS number: 122886-55-9
- 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:
- 5-9 May 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The test was conducted according to OECD Guideline 203 and in compliance with GLP. The stock solutions were prepared by agitation for about 22 hours and then filtered twice (porosity of 4-7 µm and then of 0.45 µm). The filtered solution was then further used to prepare the test solutions in the range-finding test. The measured concentrations of test substance in these solutions were below the limit of quantification (0.01 mg/L) at all measurement times. Based on the fact that the substance is highly insoluble in water (< 3 µg/L) and has a high adsorptive potential (Koc > 5.6), it can only be concluded that the LC50 > maximum solubility of the test substance in medium.
- 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
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Samples of 5 mL were taken from the limit test solution (LS) at the beginning of the test, before and after each solution change and at the end of the test. They were kept at -20°C until analysis.
- Vehicle:
- no
- Details on test solutions:
- The stock solutions, for the limit and range-finding tests, were prepared by dispersing the test item directly in test water.
A loading rate of 100 mg/L was used to prepare the stock solutions (1000 mg in 10L) by agitation of more than 22 hours. As test item particles were still in suspension after agitation, each stock solution was filtered through a filter of porosity 4-7 µm and then a filter of porosity 0.45 µm to remove the suspended fraction. The filtered solution, corresponding to the limit of solubility of the test item under the experimental conditions (LS), was then used to prepare the test solutions.
Test solutions were prepared by further dilution of this LS solution with test water to provide a geometric series of concentratons: 0 mg/L, LS/1000, LS/100, LS/10 for the range-finding test and LS for the limit test.. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: rainbow trout
- Source: CIT, animals were cultured from eggs obtained from Viviers de France, Piscicultures des Fontaines, Sarrance, France.
- Length at study initiation (length definition, mean, range and SD): 40-47 mm
- Weight at study initiation (mean and range, SD): mean was 0.786 g
- Feeding during test: no
ACCLIMATION
- Acclimation period: not stated
- Acclimation conditions (same as test or not): yes, but under flow-through system
- Type and amount of food: trout chow
- Feeding frequency: twice daily, ceasing 24 hours before the start of the test. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 156 -161 mg CaCO3/L
- Test temperature:
- 13.7 - 14.4 degrees C
- pH:
- 7.7 - 8.1
- Dissolved oxygen:
- 6.8-10 mg/L
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- LS = limit of solubility obtained from an initial loading rate of 100 mg/L for the limit test
Measured concentrations in the LS solution were below the limit of quantification (0.01 mg/L) throughout the test. - Details on test conditions:
- TEST SYSTEM
- Test vessel: not indicated
- Aeration: not during test
- Renewal rate of test solution (frequency/flow rate): every 24 hours
- No. of organisms per vessel: 5 for the range-finding test; 7 for the limit test
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: less than 1 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: filtered and dechlorinated potable water which is then softened by a Permo® water softening system. Half of the water passes directly into a holding tank attached to the flow-through system while the remaining half passes through a deionizer producing ultra-pure water which is then fed into the holding tank. This results in a 1:1 dilution of potable dechlorinated: deionized water giving a supply of the desirable hardness. The pH of the solution is between 6.0 and 8.5 and the total hardness is 150 ± 20 mg/L as CaC03.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light/8 hours dark
- Light intensity: not stated
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality at 0, 2, 4, 24, 48, 72 and 96 hours.
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: LS/1000, LS/100 and LS/10 (LS = limit of solubility obtained from an initial loading rate of 100 mg/L)
- Results used to determine the conditions for the definitive study: In the range-finding test, the mortality at LS/1000, LS/100 and LS/10 was also 0% after 96 hours. - Reference substance (positive control):
- no
- Key result
- Remarks on result:
- other: LC50 (96h): > maximum soluble concentration of test substance in test medium
- Details on results:
- In the limit test, all animals exposed to the LS solution were alive after 96 hours. No sub-lethal effect was observed in any group.
The report concluded that the 96h LC50 was > 100 mg/L (initial loading rate). The French Authorities reported the 96h LC50 as > 0.01 mg/L (measured initial). - Results with reference substance (positive control):
- None
- Sublethal observations / clinical signs:
Validity of the criteria:
- mortality in the controls did not exceed 10%
- constant conditions were maintained under semi-static conditions
- dissolved oxygen concentrations were above 60% of the air saturation value.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96-h LC50 value in fish is higher than the limit of solubility in test medium at a nominal loading rate of 100 mg/L.
- Executive summary:
The effect of the test substance on the acute toxicity of rainbow trout was assessed according to the OECD 203 guideline and following GLP principles. Under the experimental semi-static conditions, no effects were observed in the limit test, conducted with the filtrate of a 100 mg/L loading rate. The measured concentration of test substance was < LOQ (0.01 mg/L) throughout the test. It is thus assessed that the LC50 is above the maximum solubility limit of the test substance in test medium.
Reference
Description of key information
The 96-h LC50 value in fish is higher than the limit of solubility in test medium at a nominal loading rate of 100 mg/L.
Key value for chemical safety assessment
Additional information
The effect of the test substance on the acute toxicity of rainbow trout was assessed according to the OECD 203 guideline and following GLP principles. Under the experimental semi-static conditions, no effects were observed in the limit test, conducted with the filtrate of a 100 mg/L loading rate. The measured concentration of test substance was < LOQ (0.01 mg/L) throughout the test. It is thus assessed that the LC50 is above the maximum solubility limit of the test substance in test medium.
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.