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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 941-634-6 | CAS number: 1228284-78-3
- 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
- Remarks:
- The acute toxicity fish study was conducted solely to comply with a non-EU national registration requirement, and has been provided here in accordance with REACH, Article 22(1)e.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 April 2015 to 14 October 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted under a National quality assurance scheme (HJ/T 155-2004) similar to OECD GLP.
- Qualifier:
- according to guideline
- Guideline:
- other: HJ!f 153-2004, The guidelines for the testing of chemicals [S]. Beijing: SEPA, 2004
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CRC-MEP. The Guidelines for the Testing of Chemicals, Effects on Biotoc Systems [M]. 2nd edition. Beijing: China Environment Press. 2013: 30-36.
- Version / remarks:
- 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: GB/T 27861-2011, Chemicals-Fish acute toxicity test, Beijing: SAC, 2011.
- Version / remarks:
- 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: GB/T 29763-2013, Chemicals-Rare Minnow (Gobiocypris rarus) acute toxicity test Beijing: SAC, 2013.
- Version / remarks:
- 2013.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was conducted under a National quality assurance scheme (HJ/T 155-2004) similar to OECD GLP.
- Analytical monitoring:
- yes
- Details on sampling:
- Sampling and analysis of the test solution
Water samples were taken (at least in duplicate) from each concentration during the definitive test at 0, 24, 48, 72 and 96 h. On each occasion, one sample was analysed after certain pre-treatments; the remaining samples were retained in case further analysis would be required.
Pre-treatment method of the sample
50.0 ml collected water samples were diluted to 100 mL with mobile phase (2-folds diluted), and filtrated by 0.22 fill1 millipore membrane (discarding the initial 10.0 mL filtrates), then the flltrates were analysed by UPLC-PDA. - Vehicle:
- no
- Details on test solutions:
- In the range-finding test, the test solution was prepared by directly adding appropriate amounts of CA5204A in dilution water and then facilitating its dispersion by ultrasonication and stirring for 30 minutes. The amount of the test substance added was converted according to the purity of the test substance. The insoluble test substance settled at the bottom of the solution.
In the definitive test, the test medium was prepared as a slow stir super stock solution. The super stock solution (1 00 mg/L) was prepared by adding 0.3231 g CA5204A in 3 L dilution water. The aqueous test substance mixture was stirred for 24 hrs on a magnetic stirplate and a telfon stirbar at 35°C. The vortex height was set at least 10% of the static liquid height. At the end of the 24 h, stirring was stopped and the test substance was settled down to the bottom. The stock solution stands for 1 hour at room temperature prior to the removal of any undissolved test item by filtration through 0.45 micrometer millipore membrane (first approximate 100 mL discarded) to produce a 100% v/v stock solution of the test item. - Test organisms (species):
- other: Gobiocypris rarus
- Details on test organisms:
- The test species of Rare minnow, Gobiocypris rarus (Batch No.: F20150315G), were obtained from a fish supplier of Institute of Hydrobiology, Chinese Academy of Sciences.
Fish were held at least for 12 days in holding tanks supplied with a continuous flow of aerated water before being used for testing. Fish to be used in the test were held for 7 days in water of the quality and temperature to be used in the test.
A photoperiod of 16 hours light, provided by overhead fluorescent tubes, and 8 hours dark was maintained. The oxygen concentration was more than 80% of the air saturation value.
The fish were fed daily during the holding period on proprietary fish food. They were held without food for approximately 24 hours before being placed into the test vessels. The ingredients of the fish food are given as follows:
Crude Protein > 36.0%
Crude Fat > 2.0%
Crude Fibre < 3.0%
Crude Ash < 12.0%
Moisture < 10.0%
Characteristics of the fish food are measured at least twice a year by Jiangsu Provincial Center for Disease Prevention and Control.
During the holding period the tanks was inspected daily and any debris or unhealthy or dead fish removed.
After the 48 hour settling-in period, no mortality was observed in the following 7 days. So the batch of fish (Batch No.: F20 150315G) was accepted.
The average wet-weight and length of the fish used to the test was 0.226 g and 2.54 cm, and the relative standard deviation (RSD) was 8.66% and 7.07%, respectively - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 10 ~ 250 mg (CaC03)/L
- Test temperature:
- 23 ±2 °C
- pH:
- 6.0 to 8.5
- Dissolved oxygen:
- 75% to 96%
- Nominal and measured concentrations:
- Nominal concentrations of 5%, 10%, 15%, 20% and 30% stock solution were used in the defmitive test.
Measured concentrations were 0.92, 1.85, 2.98, 3.85 and 6.43 mg/L, respectively - Details on test conditions:
- Synchronously blank control was used in the test. No replicate was assigned for each treatment group and control group, while the initial number of testing fish was 10 for each group.
The test fish were randomly chosen and put in different test solutions after the temperature has been adjusted to the required value. This was done in 30 min.
During the test, the following conditions were maintained:
-Light: 16 hours photoperiod daily (light intensity: 1000 lux to 1500 lux);
-Temperature: 23.2°C to 23.SOC;
-Oxygen concentration: 75%- 96% of the air saturation; No aeration.
-Feeding: none.
At 3, 6, 24, 48, 72 and 96 h, the mortalities of the fish were recorded, and observations on individual behaviour were performed. Meanwhile, measurements of pH, dissolved oxygen and temperature were carried out and recorded daily. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate, CAS: 7778-50-9; purity: > 99.8%; Lot number: 10011460037; Nanjing Chemical Reagent Co., Ltd.
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 2.72 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.:
- 1.85 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.:
- 3.85 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- During the test period, all fish in the control and treatment of 5% stock solution (measured concentration was 2.98 mg/L) were alive and appeared normal. Effects (fish lying on side or back) occurred at nominal test concentrations of 10% stock solution (measured concentration was 1.85 mg/L). All fish were dead after 96 h-exposure at nominal test concentration of20% stock solution (measured concentration was 3.85 mg/L).
- Results with reference substance (positive control):
- - Results with reference substance valid: Yes
- LC50 (6h) = 473 mg/L
- LC50 (12h) = 410 mg/L
- LC50 (18h) = 344 mg/L
- LC50 (24h) = 277 mg/L - Sublethal observations / clinical signs:
During the test period, all fish in the control and treatment of 0.92 mg/L were alive and appeared normal.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The results showed that under valid static test conditions, the 96 h-LC50 of CA5204A to fish (Rare minnow, Gobiocypris rarus) is 2.72 mg/L, with 95% confidence limit of 2.43 mg/L ~ 3.05 mg/L (based on the measured concentration). The NOEC (96 h-LC0) is 1.85 mg/L. The minimum concentration causing 100% mortality (96 h-LC100) is 3.85 mg/L.
- Executive summary:
Under static conditions, the acute toxicity of test substance (CA5204A) to Rare mmnow (Gobiocypris rarus) was conducted according to: "The guidelines for the testing of chemicals" (HJ/f 153-2004); and with reference to Procedure 203 of the "Guidelines for Testing of Chemicals" of the OECD: "Fish, Acute Toxicity Test" (1992).
A range-finding test and then a definitive test were performed respectively. Nominal concentrations of 1.0, 10.0 and 100 mg/L were used in the range-finding test. While the nominal concentrations of 5%, 10%, 15%, 20% and 30% stock solution were used in the definitive test. Water samples taken from the blank control and the treatments in the definitive test were analysed. Concentrations of the test substance were quantified using UPLC-PDA of the measured concentrations were 0.92, 1.85, 2.98, 3.85 and 6.43 mg/L, respectively. The analytical results showed that the concentration of the test substance is consistent in the test medium throughout the 96-hour test period (deviation within 20 %). Thus a static procedure was reasonable.
In the range-fmding test, 5 fishes per treatment and no replicates were used. 10 fishes per treatment were used in the definitive test. The test fishes were exposed for 96 hours to the test solution.
During the test period, the pH values of the control medium and test medium were between 7.92 and 8.13, the Dissolved Oxygen (DO) values varied from 75% ~ 96% of the air saturation at the test temperature, and the temperature of the test mediums were maintained in the range of 23.1 oc to 23.5°C. The total hardness was in the range of 142 mg (CaC03)/L to 153 mg (CaC03)/L in the beginning of the test, and all fishes in the control group were normal. With the same conditions, K2Cr2O7 was used as the positive control substance, and the resulting 24 h-LC50 was 277 mg/L. So the study met the acceptability criteria prescribed by the protocol (pH: 6.0 ~ 8.5; dissolved oxygen concentration: > 60% of the air saturation value; total hardness: 10 ~ 250 mg (CaC03)/L; temperature: (23±2) °C; 24 h-LC50 of K2Cr2O7 in the range of 200 mg/L to 400 mg/L). Therefore the test was considered valid.
Reference
Description of key information
The results showed that under valid static test conditions, the 96 h-LC50 of the test substance to fish (Rare minnow, Gobiocypris rarus) is 2.72 mg/L, with 95% confidence limit of 2.43 mg/L ~ 3.05 mg/L (based on the measured concentration). The maximum tested concentration causing no mortality (96 h-LC0 or No Observed Effect Concentration) is 1.85 mg/L. The minimum concentration causing 100% mortality (96 h-LC100) is 3.85 mg/L
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 2.72 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.