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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 436-010-0 | CAS number: 422278-61-3 PRIMID V40-32
- 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:
- From July 9th to August 30th, 2001
- 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
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- For the analysis of the actual test item concentrations the following samples were taken:
Just before test start: - duplicate samples from each test medium
- duplicate samples from the control
After 48 and 96 hours (stability samples): - duplicate samples from each test medium
- duplicate samples from the control
All samples were taken from the approximate center of the aquaria and were deep-frozen (at about -20 °C) immediately after sampling. Based on pre-experiments for investigation of the storage stability (non-GLP) the test item is sufficiently stable in the test water under these storage conditions.
The concentration of test item was analyzed in the test medium samples of the highest test concentration from the sampling times at 0 and 96 hours. The lower test concentrations were not analyzed, since they were below the 96-hour NOEC, determined in the test. From the control samples only one of the duplicate samples was analyzed from the corresponding sampling times. - Vehicle:
- no
- Details on test solutions:
- Test solutions for each concentration were freshly prepared by dissolving test item in test water (e.g. for the 100mg/L solution, 1000mg of test item dissolved in 10 liters of test water), using ultrasonic treatment and stirring at room temperature (15 minutes each). Adequate volumes of this intensively stirred medium were added to test water in aquaria and were intensively mixed to prepare test media. Test media were freshly prepared just before introduction of fish.
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Test fish were obtained from Zoohaus Schaub, CH-4410 Liestal, Switzerland. In accordance with testing guidelines, fish were held in the laboratories of RCC for about two weeks without any medication. Prior to test start, they were acclimated for one week to the test water and temperature. During holding and acclimatization until one day before the start of the test, the fish were fed with a commercial fish diet (TETRA MIN Haupfutter, supplied by TETRA-Werke, D-49304 Melle, Germany). During holding and acclimatization no fish died in the test fish batch and all fish were healthy.
From the acclimated test fish batch, 10 fish were measured at the start of the test: the mean body lenght was 2.9 ± 0.2 cm, the mean body wet weight was 0.20 ± 0.04 g. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Not specified
- Hardness:
- 2.5 mmol/L (250 mg/L) as CaCO3
- Test temperature:
- 22-23 °C
- pH:
- 8.0
- Dissolved oxygen:
- 8.2-8.6 mg/L, considering all concentrations and all exposure times.
- Salinity:
- Analytical grade salts were dissolved in purified water to obtain the following nominal concentrations:
CaCl2 * 2H2O: 2.0 mmol/L
MgSO4 * 7H2O: 0.5 mmol/L
NaHCO3: 0.75 mmol/L
KCl: 0.075 mmol/L - Conductivity:
- Not specified
- Nominal and measured concentrations:
- Control: 0 mg/L
Nominal concentrations: 4.6, 10, 22, 46, 100 mg/L - Details on test conditions:
- One glass aquarium with 5 liters test medium was used for each test concentration and the control. Test vessels were labeled with RCC study number and all necessary additional information to assure unmistakable identification. At the start of the test 7 fish were introduced into each aquarium in a random order. The loading rate was lower than 1g fish wet weight per liter of test medium. The test media and the control were slightly aerated during the test period. The fish were not fed during the test.
Light conditions: A 16-hour light to 8-hour darkness photoperiod, with a 30 minutes transition period (light intensity approximately from 50 to 500 Lux). - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Signs of intoxication
- Details on results:
- The analytically determined test item concentrations in the analyzed test media varied in the range from 101 to 107% of the nominal values. Consequently, test item was stable during the test period and the results were reported using nominal concentrations.
All fish survived and no signs of intoxication were observed at any tested concentration, as well as in the control.
No remarkable observations were made concerning the appearance of the test media. All test media were clear solutions throughout the test period. - Results with reference substance (positive control):
- Not performed
- Validity criteria fulfilled:
- yes
- Conclusions:
- The substance is not acutely toxic to fish at a concentration up to 100 mg/L. Therefore, 96-hour LC50 of the substance is higher than 100 mg/L
- Executive summary:
Acute aquatic toxicity to fish was evaluated in a 96 -hour static study on Zebra fish, in accordance with OECD TG 203.
The nominal concentrations tested were 4.6, 10, 22, 46 and 100 mg/L.
The analytically determined test item concentrations in the analyzed test media varied in the range from 101 to 107% of the nominal values (see attached background material). Consequently, test item was stable during the test period and the results were reported using nominal concentrations. All fish survived and no signs of intoxication were observed at any tested concentration, as well as in the control. No remarkable observations were made concerning the appearance of the test media. All test media were clear solutions throughout the test period.
Therefore, the substance is not acutely toxic to fish at a concentration up to 100 mg/L. Thus, 96-hour LC50 of the substance is higher than 100 mg/L.
Reference
Description of key information
In a study according to OECD TG 203, the substance did not show any effect on fish after 96 hours of exposure at concentrations up to 100 mg/L. Therefore, LC50 (96h, Danio Rerio) > 100 mg/L
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
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.