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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 824-772-0 | CAS number: 2060540-82-9
- 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 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:
- 2018
- 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
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name PROCHINOR B657
CAS Number 2060540-82-9
Reference PROCHINOR B657
Batch number EP7377
Purity (%) 10
Expiry date 21/11/19 - Analytical monitoring:
- yes
- Details on sampling:
- Description of the protocol
For CHA: One to three steps of dilution into a 90:10 water:acetonitrile solution acidified with 0.1% formic acid or 100% acetonitrile with 0.2% formic acid, addition of an internal standard before filtration through a 0.2 µm x 13 mm PTFE filter into a vial for LC-MS/MS analysis. 5 µL were injected into the LC-MS/MS system.
For DDBS: One or two steps of dilution into a 30:70 water:acetonitrile solution acidified with 0.1% formic acid or 100% acetonitrile with 0.013% formic acid. 1 µL was injected into the LC-MS/MS system. - Vehicle:
- no
- Details on test solutions:
- Test solution preparation
The test solutions were prepared by dilution of a primary stock solution or by directly dissolving the test item in the test solution
Treatment Control PROCHINOR B657
ID C06 C07 C08 C09 C10 C11 C14
Target rate [mg test item.L-1] NA 3.1 6.25 12.5 25 50 100
Actual amount of test item weighed for preparation of SS [mg] NA 51.2 51.2 51.2 51.2 51.2 54.7
Actual volume of SS [mL] NA 500 500 500 500 500 500
Actual volume sampled from SS [mL] NA 7.8 15.6 31.25 62.5 125 250
Final volume [mL] NA 250 250 250 250 250 250
SS= Stock Solution; NA= Not Applicable - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia, Daphnia magna Strauss clone 5, between 6 and 24 hours old and produced from parthenogenically reproducing brood female population were used. Daphnia are issued from the breeding lab. The selection of the juvenile was daily realized by filtration. The juvenile stemming at least from the second litter were used to start the test.
Culture conditions:
Medium: Elendt M4
Temperature: 20 °C ± 2
Light/dark cycle: 16 h/8 h
pH: Between 6 and 9
Hardness (CaCO3): Between 140 and 250 mg.L-1
Daily feeding: Pseudokirchneriella subcapitata and Chlorella vulgaris suspensions, spirulin - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Test temperature:
- 20.4 - 20.5 (°C)
- pH:
- 8.0 - 8.2
- Dissolved oxygen:
- 9.0 - 9.2 (mg O2/L)
- Nominal and measured concentrations:
- Nominal concentrations: 3.1 ; 6.25 ; 12.5 ; 25 ; 50 and 100 mg test item.L-1
Measured concentrations: 2.16 ; 3.02 ; 9.16 ; 18.36 ; 41.58 ; 90.99 mg test item. L-1 - Details on test conditions:
- Based on the results of the no-GLP range-finder, concentrations were prepared in OECD medium at 6 rates equivalent to: 3.1 ; 6.25 ; 12.5 ; 25 ; 50 and 100 mg test item.L-1. A control was set up with the test medium only. There were 4 replicates for each treatment and for the control. 5 daphnids were introduced in each replicate (each one containing 50 mL of test solution).
Organisms were maintained at temperature of 20°C ± 2°C and light intensity under 300 lux with a light:dark cycle of 16 hours light and 8 hours dark.
After 24 and 48 hours, the number of immobile daphnids in each replicates were recorded. pH dissolved oxygen and temperature were recorded at the beginning and the end of the test. - Reference substance (positive control):
- yes
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 40.64 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Details on results:
- cf Table 1
- Results with reference substance (positive control):
- 24-hour EC50: 1.428 mg.L-1
cf details in Table 2 - Validity criteria fulfilled:
- yes
- Conclusions:
- CONCLUSION
EC50-48h (95% confidence limits) 40.64 mg.L-1 (33.03– 49.83 mg.L-1)
The acute effects of PROCHINOR B657 diluted in OECD test medium at the definitive rates of 3.1 ; 6.25 ; 12.5 ; 25 ; 50 and 100 mg.L-1 to Daphnia magna were investigated under laboratory conditions.
The study is valid since
- immobilization in the control was less than 10% (actual values: 0% in the definitive test)
- dissolved oxygen in the lowest concentration producing the maximum effect at the end of the test was = 3 mg.L-1 (actual values: 9.1 mg.L-1 mg.L-1 in the definitive test)
- the EC50 with reference item over a period of 24 hours was between 0,6 and 2,1 mg.L-1 (actual value: 1.43 mg.L-1). - Executive summary:
The objective of this study was to assess the effects of the test item PROCHINOR B657 on the mobility of Daphnia magna over a period of 48 hours under static conditions according to OECD Guideline 202 (April 2004).
The test item is a soluble substance under the test conditions and the test solutions were prepared by dilution of a primary stock solution or by directly dissolving the test item in the test solution.
Test item quantification was performed according to a validated analytical method using a LC-MS/MS from Sciex (Exion LC and MS QTRAP 5500) as mass spectrometry detection to measure both DDBS and CHA from PROCHINOR B657 concentrations at 0 and 48 hours.
Results are the following:
PROCHINOR B657
EC10-48h(95% confidence limits)
24.06 mg.L-1(15.34 – 30.17 mg.L-1)
EC50-48h(95% confidence limits)
40.64 mg.L-1(33.03– 49.83 mg.L-1)
EC = effect concentration
The acute effects of PROCHINOR B657 diluted in OECD test medium at the definitive rates of 3.1 ; 6.25 ; 12.5 ; 25 ; 50 and 100 mg.L-1to Daphnia magna were investigated under laboratory conditions.
The study is valid since immobilization in the control was less than 10% (actual values: 0% in the definitive test), dissolved oxygen in the lowest concentration producing the maximum effect at the end of the test was = 3 mg.L-1(actual value: 9.1 mg.L-1in the definitive test) and the EC50with reference item over a period of 24 hours was between 0,6 and 2,1 mg.L-1(actual value: 1.43 mg.L-1).
Reference
TABLE 1:
ID |
Target rate |
Immobilized daphnids 48 hours after exposure |
Total of immobilized daphnids |
Mean of immobilized daphnids (%) |
|||
[mg test item.L-1] |
Replicates |
||||||
A |
B |
C |
D |
||||
C06 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C07 |
3.1 |
0 |
0 |
0 |
0 |
0 |
0 |
C08 |
6.25 |
0 |
0 |
0 |
0 |
0 |
0 |
C09 |
12.5 |
0 |
0 |
0 |
0 |
0 |
0 |
C10 |
25 |
1 |
0 |
0 |
0 |
1 |
5 |
C11 |
50 |
2 |
3 |
3 |
1 |
9 |
45 |
C14 |
100 |
5 |
5 |
5 |
5 |
20 |
100 |
TABLE 2:
ID |
Rate |
Immobilized daphnids 24 hours after exposure |
Total of immobilized daphnids |
Mean of immobilized daphnids (%) |
|||
[mg reference item.L-1] |
Replicates |
||||||
A |
B |
C |
D |
||||
T |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C1 |
0,5 |
0 |
0 |
0 |
0 |
0 |
0 |
C2 |
0,9 |
0 |
1 |
0 |
0 |
1 |
5 |
C3 |
1,35 |
3 |
1 |
2 |
2 |
8 |
40 |
C4 |
2,025 |
5 |
4 |
4 |
5 |
18 |
90 |
C5 |
3,0375 |
5 |
5 |
5 |
5 |
20 |
100 |
Description of key information
The objective of this valid study was to assess the effects of the test item on the mobility of Daphnia magna over a period of 48 hours under static conditions according to OECD Guideline 202 (April 2004).
The test item is a soluble substance under the test conditions and the test solutions were prepared by dilution of a primary stock solution or by directly dissolving the test item in the test solution.
Test item quantification was performed according to a validated analytical methodusing a LC-MS/MS from Sciex (Exion LC and MS QTRAP 5500) as mass spectrometry detection to measure both DDBS and CHA from PROCHINOR B657 concentrations at 0 and 48 hours.
The acute effects of the test item diluted in OECD test medium at the definitive rates of 3.1 ; 6.25 ; 12.5 ; 25 ; 50 and 100 mg.L-1to Daphnia magna were investigated under laboratory conditions.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 40.64 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.