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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 448-300-4 | CAS number: 88642-03-9
- 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
- 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)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD series on testing and assessment no. 23 (second edition)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: All concentration levels and the control were analytically verified via GC-MS in the fresh media at the start of exposure and at the renewal of the test solutions (0 and 24 hours) as well as in the 24-hours old media at the renewal and at the end of the exposure (24 and 48 hours).
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: In a glass column an appropriate amount of sea sand (washed twice with acetone) was spiked with an appropriate amount of the test item as follows. An appropriate amount of the test item was dissolved in an apropiate amount of acetone. An appropriate amount of this stock solution were mixed thoroughly with 23.4 g of the sea sand in a glass petri dish. After complete evaporation of the solvent, the dry sea sand was filled into the column. The column was connected with a tubing pump. For preparation of the saturated solution, the generator column was rinsed with demineralized water in a circuit within 95 hours by a tubing pump. After 4 days, an aliquot of 1000 mL of the saturated solution was taken from the center of the water body and was checked for undissolved test item (formation of an emulsion). The Tyndall effect was negative and, thus, undissolved test item was not present. Thereafter, the mineral components of the dilution water were added.
- Preparation test concentrations: The saturated solution containing the mineral components was used as the highest concentration level and as a stock solution for the preparation of further concentration levels by dilution with dilution water. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Age at study initiation: Less than 24 hours
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), Germany
- Feeding during test : non
CULTURE
- Medium: Elendt M4, according to OECD 202, Annex 3 (2004)
- Feeding: at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus
ACCLIMATION
- Acclimation period: Acclimatization was not necessary, composition of the dilution water was equivalent to the culture medium. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 269 - 278 mg CaCO3/L
- Test temperature:
- 20.8 - 21.3 °C
- pH:
- 0 h: 7.6 - 8.4
24 h (old): 7.6 - 8.2
24 h (new): 7.3 - 8.2
48 h: 7.3 - 7.8 - Dissolved oxygen:
- 0 h: 8.19 - 8.74 mg/L
24 h (old): 8.06 - 8.69 mg/L
24 h (new): 7.65 - 8.15 mg/L
48 h: 7.00 - 8.10 mg/L - Conductivity:
- 589 - 592 µS/cm
- Nominal and measured concentrations:
- Nominal dilution levels: control, 6.25 - 12.5 - 25.0 - 50.0 - 100% of the saturated solution
Geometric mean measured concentrations: control, 51.4 – 101 – 192 – 366 – 834 µg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Sealed glass flasks with screw caps
- Type: closed
- Headspace, fill volume: no headspace, 130 ml fill volume
- Volume of solution: 130 ml
- Aeration:none
- Renewal rate of test solution: every 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: no
- Intervals of water quality measurement:
- Temperature was recorded throughout the period of the test.
- Dilution water: pH value, dissolved oxygen concentration, temperature, conductivity and total hardness prior to the start of the exposure (0 hours) and the renewal of the test solutions (24 hours)
Test solution: At 0 and 24 hours (new medium), pH value, dissolved oxygen concentration) were measured in one additional replicate per concentration level and control. At 24 and 48 hours (old medium) in one appropriate replicate (containing daphnids) per concentration level and control. The replicate with the highest immobilization rate per concentration level and control was measured
OTHER TEST CONDITIONS
- Photoperiod: 16/8 hours light/dark cycle
- Light intensity: Diffuse light, light intensity of max. 1500 lx
EFFECT PARAMETERS MEASURED: Immobilization after 24 and 48 hours and any adverse, sub-lethal effects (e.g. discoloration, abnormal behavior etc.)
RANGE-FINDING STUDY
- Test concentrations: control, 1, 10, 100% of saturated solution
- Results used to determine the conditions for the definitive study: 100% immobilization in 100% of the saturated solution - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 265 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% confidence limits: 241 – 292 µg/L
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 192 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 834 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities:
none
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Immobilisation of control: none
- Abnormal responses: none - Results with reference substance (positive control):
- EC50 (24 h) = 2.17 mg/L
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the geometric mean measured concentrations of the test item the 48 hours-EC50 for Daphnia magna was 265 µg/L (95% confidence limits: 241 – 292 µg/L).
Reference
Measured Concentrations of the Test Item during the Definitive Test
Sampling |
Fresh media, |
Old media, |
Fresh media, |
Old media, |
|
||
Dilution level of [%] |
test item |
||||||
Meas. conc. [µg/L] |
Meas. conc. [µg/L] |
% |
Meas. conc. [µg/L] |
Meas. conc. [µg/L] |
% |
Geometric mean Measured concentration [µg/L] |
|
100 |
1060 |
624 |
59 |
1193 |
613 |
51 |
834 |
50.0 |
444 |
297 |
67 |
458 |
298 |
65 |
366 |
25.0 |
242 |
154 |
64 |
230 |
159 |
69 |
192 |
12.5 |
113 |
73.9 |
66 |
147 |
86.2 |
59 |
101 |
6.25 |
57.0 |
40.3 |
71 |
73.1 |
41.6 |
57 |
51.4 |
Control |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
Meas. conc. = measured concentration of the test item
% = percentage of the initially measured concentration of the test item
LOQ = limit of quantification (4 µg test item/L)
Immobilization Rates after 24 and 48 hours of Exposure in the Definitive Test
Geometric mean measured test item concentration |
IMMOBILIZATION [%] |
|||||||||
24 hours |
48 hours |
|||||||||
Replicates |
Replicates |
|||||||||
1 |
2 |
3 |
4 |
MV |
1 |
2 |
3 |
4 |
MV |
|
834 |
100 |
80 |
100 |
100 |
95 |
100 |
100 |
100 |
100 |
100 |
366 |
60 |
60 |
80 |
60 |
65 |
80 |
80 |
100 |
100 |
90 |
192 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
20 |
10 |
101 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
51.4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Description of key information
The 48-hour EC50 for Daphnia magna = 265 µg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 265 µg/L
Additional information
One acute invertebrates toxicity study is available. The short-term toxicity to Daphnia magna was determined in a 48 hour test according to OECD guideline 202 and conducted in compliance with GLP (2019). Organisms were exposed to measured concentrations (geometric mean) of 51.4, 101, 192, 366 and 834 µg/L in a closed system under semi-static conditions. The EC10, EC50 and EC100 based on mobility were determined to be 192, 265 and 834 µg/L, respectively. This study is considered reliable and relevant (Klimisch 1) and is suitable for use as a key study.
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.