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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 286-185-0 | CAS number: 85187-95-7
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From April 09 to 12, 2017. Definitive exposure phase from April 10 to 12, 2017.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Determination of the test item
All concentration levels and the control were analytically verified via LC-MS/MS in fresh media at the start of the exposure (0 hours) and in old media at the end of the exposure period (48 hours) as specified below. The analytical method was validated prior to this study according to SANCO 3029/99 rev.4 (2000).
Sampling for the analytical monitoring
At the start of the exposure (0 hours), samples were taken from all freshly prepared concentration levels and the control for analysis. At the end of the exposure (48 hours), samples for the analyses of the old media were taken directly from the test vessels.
Criteria for the analytical monitoring (target)
Recoveries of the active substances should be within ± 20% of the nominal or initially measured concentrations. - Vehicle:
- no
- Details on test solutions:
- Preparation of the stock solution
A stock solution (1.00 mg/L of the test item was weighed out) was prepared with dilution water on day prior to the start of the exposure period (at -24 hours). The test item was mixed with the dilution water by constant stirring with a magnetic stirrer at approximately 1100 rpm for 24 hours at room temperature. After completion of stirring, the stock solution was checked via laser beam (Tyndall effect) for undissolved test item. No Tyndall effect was present in the stock solution. Therefore, the solution was used as the highest concentration level and for the preparation of further concentration levels by dilution with dilution water to get the definitive test concentrations.
Test concentrations
5 test item concentrations in a geometric series with a separation factor of 2, prepared by dilution of the stock solution 1.00 mg/L with dilution water, were tested as follows:
0.0625 - 0.125 - 0.250 - 0.500 - 1.00 mg/L
The test concentrations were selected based on the results of a non-GLP preliminary range finding test.
Control
Dilution water without test item incubated under the same conditions as the test groups - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test system
Daphnia magna STRAUS (Clone 5)
Reason for the selection of the test system
Daphnia magna is the preferred species in accordance with the test guideline and is bred at the test facility.
Origin
Institut für Wasser-, Boden- und Lufthygiene (WaBoLu),
14195 Berlin, Germany
Breeder
Noack Laboratorien GmbH,
Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
Culture
In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 2 °C, in an incubator, 16 hours illumination; light intensity of max. 1500 lx
Culture medium
Elendt M4, according to OECD 202, Annex 3 (2004), modified to a total hardness of 160 to 180 mg CaCO3/L, is used.
Culture feeding
The culture daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 106 cells/mL. The algae were cultured at the test facility.
Origin of the food algae
Sammlung von Algenkulturen (SAG),
Pflanzenphysiologisches Institut der Universität Göttingen, Nikolausberger Weg 18, 37073 Göttingen, Germany - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- see any other information on material and methods incl. tables
- Test temperature:
- see any other information on material and methods incl. tables
- pH:
- see any other information on material and methods incl. tables
- Dissolved oxygen:
- see any other information on material and methods incl. tables
- Conductivity:
- see any other information on material and methods incl. tables
- Details on test conditions:
- Test method
The study was performed under static conditions.
Test duration
48 hours
Test vessels
Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses
Test volume
20 mL in each test replicate (see ‘Application’)
Dilution water
Same as culture medium
Number of daphnids and replicates
20 daphnids, divided into 4 replicates, each with 5 daphnids, were used for each loading level and the control.
Age of the daphnids
Less than 24 hours old daphnids from a healthy stock were used for at the start of the exposure the study. Juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period of max. 24 hours preceding the exposure were used for the test. No first brood progeny was used for the test.
Acclimatization
Acclimatization of the daphnids was not necessary, because the dilution water was equivalent to the culture medium.
Application
20 g test solution per replicate was weighed out into each test vessel. This corresponds to 20 mL per test vessel. The daphnids were inserted with a small amount of dilution water by a pipette.
Test temperature (target)
18 - 22 °C, constant within ± 1 °C
Illumination (target)
Diffuse light, light intensity of max. 1500 lx
Photoperiod (target)
16/8 hours light/dark cycle
Feeding
The daphnids were not fed during the study. - Reference substance (positive control):
- yes
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 0.250 - 1.00
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.266 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 0.227 - 0.319
- Duration:
- 24 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.287 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 0.250 - 1.00
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.145 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: <0.0625 - 0.195
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- The percentage of immobility for the reference item potassium dichromate (SIGMA-ALDRICH, batch number MKBV0900V, purity 99.0%, CAS RN 7778-50-9) was determined after 24 hours from 2017 04-06 to 2017-04-07.
EC50-Value (with 95% confidents limits) of the Reference Item Potassium dichromate
based on nominal concentrations mg/L, (0 - 24 hours)
Current Study Valid Range
EC50 1.72 mg/L
0.6 - 2.4 mg/L, acc. to AQS P 9/2 (02/2000); clone 5
0.6 - 2.1 mg/L, acc. to OECD 202 (2004); clone A
95% confidence limits 1.34 - 1.93 mg/L - Reported statistics and error estimates:
- Methods of evaluation The EC100-values (after 24 and 48 hours) were empirically derived from the observed immobilization rates.
The effect concentrations (EC10 / 50 / 100) were based on the nominal concentrations of the test item, since the test item concentrations were within ± 20% of the nominal concentrations.
EC-values and statistical analyses
The EC10 / 50-values after 24 hours were calculated by linear dose-response regression and the EC10 / 50-values after 48 hours were calculated by sigmoidal dose-response regression. Since only one partial effect was observed after 24 hours, the highest concentration level resulting in 0% immobilization and the lowest concentration level causing 100% immobilization were used as 95% confidence limits for the EC10 / 50-values after 24 hours. The respective 95% confidence limits for the EC10 / 50-values after 48 hours were calculated from the standard error and the t-distribution. All calculations were carried out from the best-fit values with the software GraphPad Prism5. The concentration effect relationships are shown graphically.
The EC50-value with 95% confidence limits for the reference item was calculated accordingly, by sigmoidal dose-response regression.
Software
All data were computer-processed and rounded for presentation. Consequently, minor variations may occur from the original figures if manual calculations based on the original figures are made subsequently. Calculations were made using the following software:
- GraphPad Prism5, GRAPHPAD SOFTWARE, INC.
- Excel, MICROSOFT CORPORATION - Validity criteria fulfilled:
- yes
- Conclusions:
- 48 hour EC50 was 0.266 mg/L (95% confidence limits: 0.227 – 0.319 mg/L).
- Executive summary:
Method
In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item were determined at the test facility according to OECD 202 (2004) from 2017-04-09 to 2014-04-12, with the definitive exposure phase from 2017-04-10 to 2017-04-12.
The study was conducted under static conditions over a period of 48 hours with five nominal concentrations of the test item ranging from 0.0625 to 1.00 mg/l in a geometric series with a separation factor of 2.
The test item is a red powder, which is dispersible with water. All test item concentrations were visually clear throughout the exposure period. The concentration levels 0.250 to 1.00 mg/l showed a concentration-related strong to light orange colour. The concentration level of 0.125 mg/l was slightly orange in fresh medium and colorless in old medium. The orange colour was clearer in fresh media (0 hours) than in old media (48 hours) at the respective concentration levels. The concentration level 0.0625 mg/L was colourless throughout the exposure period.Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration leveland the control.
The concentrations of the test item were analytically verified via LC-MS/MS in fresh media at the start of the exposure (0 hours) and in old media at the end of the exposure period (48 hours) in all tested concentration levels and in the control.
Results
The measured concentrations of the test item in fresh media at the start of the exposure (0 hours) were in the range of 105 to 111 % of the nominal values in all test item concentrations. In old media at the end of the exposure period (48 hours), the measured test item concentrations were in the range of 97 to 104 % of the nominal values of the test concentrations. The measured concentrations of the test item remained stable within ± 20 % of the nominal concentrations throughout the exposure period and no hint for possible degradation products was observed in the respective chromatograms, which indicates that the test item concentrations were successfully maintained for the duration of the test.
All effect concentrations (EC10 / 50 / 100) are based on the nominal concentrations of the test item.
The validity criteria of the test guideline were fulfilled.
EC10-, EC50- (with 95 % Confidence Limits) and EC100-Values
(based on the nominal concentrations of the test item)
Basic Red 18.1 Chloride
Effect concentrations
Test
duration
[hours]
Toxicity endpoint
based on the nominal concentrations of the test item[mg/L]
EC10
(with 95% confidence limits)
24
0.287
(Cl: 0.250 – 1.00)
48
0.145
(Cl:≤0.0625 – 0.195)
EC50
(with 95% confidence limits)
24
0.500
(Cl: 0.250 – 1.00)
48
0.266
(Cl: 0.227 – 0.319)
EC100
24
1.00
48
1.00
Reference
Immobilization Ratesafter 24 and 48 hours ofExposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
Nominal test item concentration [mg/L] |
IMMOBILIZATION [%] |
|||||||||
24 hours |
48 hours |
|||||||||
Replicates |
Replicates |
|||||||||
1 |
2 |
3 |
4 |
MV |
1 |
2 |
3 |
4 |
MV |
|
1.00 |
100 |
100 |
100 |
100 |
100 |
100% mortality after 24 hours |
||||
0.500 |
20 |
60 |
60 |
60 |
50 |
60 |
100 |
100 |
100 |
90 |
0.250 |
0 |
0 |
0 |
0 |
0 |
40 |
60 |
60 |
20 |
45 |
0.125 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
0 |
5 |
0.0625 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Absolute Numbers of immobileDaphnids after 24 and 48 hours ofExposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
Nominal test item concentration [mg/L] |
Number of immobile Daphnids / Total number of Daphnids |
|||||||||
24 h |
48 h |
|||||||||
Replicates |
Replicates |
|||||||||
1 |
2 |
3 |
4 |
MV |
1 |
2 |
3 |
4 |
MV |
|
1.00 |
5 / 5 |
5 / 5 |
5 / 5 |
5 / 5 |
20 / 20 |
5 / 5 |
5 / 5 |
5 / 5 |
5 / 5 |
20 / 20 |
0.500 |
1 / 5 |
3 / 5 |
3 / 5 |
3 / 5 |
10 / 20 |
3 / 5 |
5 / 5 |
5 / 5 |
5 / 5 |
18 / 20 |
0.250 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
2 / 5 |
3 / 5 |
3 / 5 |
1 / 5 |
9 / 20 |
0.125 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
0 / 5 |
0 / 5 |
1 / 5 |
0 / 5 |
1 / 20 |
0.0625 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
Control |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 5 |
0 / 20 |
Additional Observations during the Definitive Test
All test item concentrations were
visually clear throughout the exposure period. The concentration levels
0.250 to 1.00 mg/L showed a concentration-related strong to light orange
colour. The concentration level of 0.125 mg/L was slightly orange in
fresh medium and colorless in old medium. The orange colour was clearer
in fresh media (0 hours) than in old media (48 hours) at the respective
concentration levels. The concentration level 0.0625 mg/L was colourless
throughout the exposure period. Since colour of the test solutions is
observed visually without measurement of wavelength, differences between
Range Finder and Main Study (red – orange) are considered to be
subjective and not test item related.
Water Quality Parameters
The measured water quality parameters(i.e. pH-value, dissolved oxygen concentration, total water hardness and water temperature) were within the acceptable limits.
During the test period, the temperature in the incubator was 19 - 20 °C.
Measured Exposure Concentrations during the Definitive Test
The concentrationsof the test item were analytically verified via LC-MS/MS in fresh media at the start of the exposure (0 hours) and in old media at the end of the exposure period (48 hours) in all tested concentration levels and in the control.
The measured concentrations of the test item in fresh media at the start of the exposure (0 hours)were in the range of 105 to 111% of the nominal values in all test item concentrations. In old media at the end of the exposure period (48 hours), the measured test itemconcentrations were in the range of 97 to 104% of the nominal values of the test concentrations.The measured concentrations of the test itemBasic Red 18.1 Chloride remained stable within ± 20% of the nominal concentrations throughout the exposure period, which indicates that the test item concentrations were successfully maintained for the duration of the test.
Measured Concentrations of the Test ItemBasic Red 18.1 Chlorideduring the Definitive Test
Sampling date |
2017-04-10 Start of the exposure, 0 hours |
2017-04-12 End of the exposure, 48 hours |
||
Start of analysis |
2017-04-10 |
2017-04-12 |
||
Nominal test item concentration [mg/L] |
Basic Red 18.1 Chloride |
|||
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
|
1.00 |
1.11 |
111 |
1.04 |
104 |
0.500 |
0.527 |
105 |
0.503 |
101 |
0.250 |
0.2711) |
108 |
0.249 |
99 |
0.125 |
0.1391) |
111 |
0.126 |
101 |
0.0625 |
0.06881) |
110 |
0.0604 |
97 |
Control |
< LOQ |
< LOQ |
Meas. conc. = measured concentration of the test item, mean value of two injections, dilution factors taken into account
% = percent of the nominal concentration of the test item
LOQ = limit of quantification of the analytical method (0.005 mg/L of thetest item)
1) = reanalyzed on 2017-04-12, mean value of 2 replicates with 2 injections each
Description of key information
EC50 (48h)= 0.266 mg/l
Key value for chemical safety assessment
Additional information
No studies on "short-term toxicity to aquatic invertebrates" are available on the Target Substance in itself. However a study conducted on a Similar Substance has been used for the assessment.Similar Substance 02 differ from the Target one only on the salification. More information are reported in section 13.
In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item were determined at the test facility according to OECD 202 (2004) from 2017-04-09 to 2014-04-12, with the definitive exposure phase from 2017-04-10 to 2017-04-12.
The study was conducted under static conditions over a period of 48 hours with five nominal concentrations of the test item ranging from 0.0625 to 1.00 mg/l in a geometric series with a separation factor of 2.
The test itemis a red powder, which is dispersible with water.All test item concentrations were visually clear throughout the exposure period. The concentration levels 0.250 to 1.00 mg/l showed a concentration-related strong to light orange colour. The concentration level of 0.125 mg/l was slightly orange in fresh medium and colorless in old medium. The orange colour was clearer in fresh media (0 hours) than in old media (48 hours) at the respective concentration levels. The concentration level 0.0625 mg/L was colourless throughout the exposure period.Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration leveland the control.
The concentrations of the test itemwereanalytically verified via LC-MS/MS in fresh media at the start of the exposure (0 hours) and in old media at the end of the exposure period (48 hours) in all tested concentration levels and in the control.
The measured concentrations of the test item in fresh media at the start of the exposure (0 hours) were in the range of 105 to 111 % of the nominal values in all test item concentrations. In old media at the end of the exposure period (48 hours), the measured test itemconcentrations were in the range of 97 to 104 % of the nominal values of the test concentrations.The measured concentrations of the test item remained stable within ± 20 % of the nominal concentrations throughout the exposure period and no hint for possible degradation products was observed in the respective chromatograms, which indicates that the test item concentrations were successfully maintained for the duration of the test.
All effect concentrations (EC10 / 50 / 100) are based on the nominal concentrations of the test item.
The validity criteria of the test guideline were fulfilled.
EC10-, EC50- (with 95 % Confidence Limits) and EC100-Values
(based on the nominal concentrations of the test item)
BasicRed 18.1 Chloride |
|||
Effect concentrations
|
Test duration [hours] |
Toxicity endpoint [mg/L] |
|
EC10 (with 95% confidence limits) |
24 |
0.287 |
(Cl: 0.250 – 1.00) |
48 |
0.145 |
(Cl:≤0.0625 – 0.195) |
|
EC50 (with 95% confidence limits) |
24 |
0.500 |
(Cl: 0.250 – 1.00) |
48 |
0.266 |
(Cl: 0.227 – 0.319) |
|
EC100 |
24 |
1.00 |
|
48 |
1.00 |
|
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.