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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 813-271-2 | CAS number: 439661-46-8
- 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov. 2016 - Feb. 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: ROC-601
CAS Number: 439661-46-8
Appearance: White crystalline powder
Purity: 99.5 %
Storage: at room temperature, avoid exposure to light
Lot no: S23PSG0816
Expiration date: June 28, 2018 - Analytical monitoring:
- yes
- Details on sampling:
- For determination of the test item concentration, four replicate samples were taken from the test item treatment group at the start and end of each renewal period of the test. Two control samples were analysed on each analytical occasions.
The analysis of the test item ROC-601was performed by the analytical laboratory of TOXI-COOP ZRT. according to the results of the analytical method validation (Study number: 888-100-1898) by HPLC method with UV detection. - Vehicle:
- no
- Details on test solutions:
- For preparation of test solution a supersaturated solution (100 mg/L nominal loading) was prepared by adding an amount of 0.05 g test item in 500 mL test medium (ISO medium). This supersaturated solution was shaken for 20 hours and thereafter the non-dissolved test material was removed by filtration through a 0.22 µm membrane filter to obtain the saturated test solution. The test solution was freshly prepared in the testing laboratory just before introduction of the test animals (start of each renewal period of the experiment).
Composition of ISO medium:
Substance:Nominal concentration of the stock solutions (g/L)
CaCl2 x 2 H2O: 11.76 g/L
MgSO4 x 7 H2O: 4.93 g/L
NaHCO3: 2.59 g/L
KCl: 0.23 g/L - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species and strain: Daphnia magna (Straus)
Origin: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection), 2100-Gödöllő, Kotlán S. u. 3. Hungary
Breeding: The Daphnia are bred in the Laboratory of TOXI-COOP ZRT.
Number of animals: Twenty animals in both groups (concentration and untreated control), divided into 4 concurrent batches (5 animals per batch).
Age of animals: Less than 24 h old at the beginning of the test.
Sex: Female
Animal health: Apparently healthy animals were used in this test with a known history
Acclimatization: Test animals were bred under similar (or the same) conditions as that used during the exposure period (holding water, temperature, background colour etc.), therefore additional acclimatisation before the test was not necessary. Brood daphnids were maintained in dilution water at the test temperature for at least 48 hours prior to the start of the test.
Food and Feeding: The Daphnia were fed with concentrated algal suspension of Raphidocelis subcapitata during the holding. Test animals were not fed during the exposure.
Reconstituted water (ISO medium, according to OECD 202) was used as dilution water in the experiment. Separate stock solutions of individual substances were first prepared in deionised water (prepared in TOXI-COOP ZRT. by MILLIPORE ELIX 3 water purification system). The ISO medium was prepared by adding 25 mL from each of four stock solutions to one litre deionised water. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- Standard exposure time according to OECD guideline
- Post exposure observation period:
- None
- Hardness:
- The measured hardness of ISO medium was 237 mg/L.
- Test temperature:
- 19.8 – 20.4 °C measured in the test vessels during the test
- pH:
- The pH was in the range of 7.77 – 8.02 during the test
- Dissolved oxygen:
- 7.56 – 8.37 mg/L during the test
- Conductivity:
- not measured
- Nominal and measured concentrations:
- Based on the results of the non-GLP Preliminary Range-Finding Test (see above), the main test included a nominal concentration of 100 mg/L (limit test) and a concurrent control group. The exposure concentration was calculated as the geometric mean of the start and end values of each renewal period and determined to be 1.97 µg/L analytically.
- Details on test conditions:
- The test item is unstable in light; therefore, the experiment was carried out in complete darkness.
- Reference substance (positive control):
- yes
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 1.97 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Remarks on result:
- other: equivalent to > 100 mg/L nominal
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1.97 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Remarks on result:
- other: equivalent to > 100 mg/L nominal
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.97 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Remarks on result:
- other: equivalent to > 100 mg/L nominal
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 1.97 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Remarks on result:
- other: equivalent to > 100 mg/L nominal
- Details on results:
- Validity of the Study
Immobilisation was not observed in the control group and the dissolved oxygen concentration at the end of the test in control and test vessels was more than 3 mg/L in all cases. All validity criteria were within acceptable limits and therefore the study can be considered as valid.
Analytical Results
A saturated test item solution (limit concentration) and a concurrent control were included in the main test. The concentration of the test item was analytically determined at the start and at the end of each renewal period of the experiment.
The test item was not detected in the untreated control group.
In the treated group mean of the measured concentrations was 1.89 µg/L at the start and 0.98 µg/L at the end of the first renewal period. In the second renewal period the measured test item concentrations were 3.56 µg/L at the start and 2.29 µg/L at the end. The exposure concentration was calculated as the geometric mean of the start and end values of each renewal period and determined to be 1.97 µg/L. This concentration was considered as the saturation concentration in the test medium (equivalent to 100 mg/L nominal concentration).
Biological Results
There was no immobilisation observed in twenty daphnids exposed to either test item treated or control group. In addition to immobility, no abnormal behaviour or appearance of test animals was detected. - Results with reference substance (positive control):
- For the evaluation of the quality of the Daphnia clone and the experimental conditions, Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions. The date of the last study (Study Code: 392-202-1922) with reference item Potassium dichromate was 20 - 21 September 2016.
The 24h EC50 value was determined to be 1.57 mg/L (95% conf. limits: 1.31 – 1.79 mg/L).
Name and data of Reference Item
Name: Potassium dichromate (K2Cr2O7)
Batch No.: MKBN3524V
Description: Orange crystalline powder
Expiry Date: 04 March, 2018
Storage: Room temperature
Supplier: SIGMA-ALDRICH - Reported statistics and error estimates:
- A limit test was performed and toxic effects were not observed. Therefore, statistical analysis was not necessary. The NOEC, LOEC and ECx values of the test item were determined directly from the raw data.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the results of this study, the test item ROC-601 had no toxic effect at aquatic saturation (i.e. water accommodated fraction, WAF) on Daphnia magna; the EC10, EC20, EC50 results and the LOEC are higher than the solubility level of the test item in the test medium (1.97 µg/L on average), which corresponds to a nominal concentration of 100 mg/L.
- Executive summary:
Following a limit test in which daphnia were exposed to the test item for 48 hours at the limit of its solubility in the test medium (i.e.water accommodated fraction, WAF) indicating that the test item has no influence on the mobility of Daphnia up to at least the saturation concentration (equivalent to 100 mg/L nominal concentration), a full study was performed.
The substance ROC-601 was assessed using Daphnia magna in a 48-hour acute immobilisation test. Young Daphnia were exposed to aqueous test media containing the test item for 48 hours in a semi-static test.
The quantification of the test item ROC-601 was performed by a previously validated analytical method. Samples were taken from the test concentration and the control at the start and at the end of each renewal period of the experiment and analysed by HPLC methodwith UV detection. The determined exposure concentration of the test item was 1.97 µg/L which was calculated as the geometric mean of the measured start and end concentrations.
Twenty Daphnia (divided into 4 concurrent batches) were tested each, exposed to the saturated test concentration and in the control (ISO medium). Environmental conditions were recorded and remained within acceptable ranges.
The immobilisation of the test animals was recorded 24 and 48 hours after treatment. There was no immobilisation in twenty daphnids exposed to either test item treated or control group and no abnormal behaviour or appearance of test animals was detected.
All validity criteria were met and therefore the study can be considered as valid.
In conclusion the test item ROC-601 had no toxic effect at aquatic saturation (i.e.water accommodated fraction, WAF) on Daphnia magna; the EC10,EC20,EC50 results and the LOEC are higher than the solubility level of the test item in the test medium (> 1.97 µg/L), which corresponds to a nominal concentration of 100 mg/L.
Reference
ROC-601concentrations measured in the test solutions
Nominal Concentration |
Measured concentrationswith 95% confidence interval, µg/L |
|||
1stRenewal Period |
2ndRenewal Period |
|||
Start |
End |
Start |
End |
|
100 |
1.95 |
0.96 |
3.59 |
2.55 |
2.00 |
1.06 |
3.81 |
2.09 |
|
1.76 |
0.87 |
3.33 |
2.40 |
|
1.85 |
1.01 |
3.53 |
2.10 |
|
Meanwith 95% confidence interval, (µg/L) |
1.89 ± 0.17 |
0.98 ± 0.13 |
3.56 ± 0.31 |
2.29 ± 0.37 |
Immobilization of the test animals
Test Group |
Replicate |
Number of |
Number of immobilised animals |
|
24 h |
48 h |
|||
Control |
1 |
5 |
0 |
0 |
2 |
5 |
0 |
0 |
|
3 |
5 |
0 |
0 |
|
4 |
5 |
0 |
0 |
|
Saturated test |
1 |
5 |
0 |
0 |
2 |
5 |
0 |
0 |
|
3 |
5 |
0 |
0 |
|
4 |
5 |
0 |
0 |
Description of key information
The test item ROC-601 had no toxic effect at aquatic saturation (i.e.water accommodated fraction, WAF) on Daphnia magna; the EC10, EC20, EC50 results and the LOEC are higher than the solubility level of the test item in the test medium (> 1.97 µg/L), which corresponds to a nominal concentration of 100 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- 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.