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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-635-0 | CAS number: 98-08-8
- 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:
- from 2005-05-12 to 2005-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Methods of Testing New Chemical Substances (Algae growth inhibition test, Daphnia acute immobilization test, and Fish acute toxicity test) (Yakushokuhatsu No. 1121002, Heisei 15・ 11・13 Seikyoku No. 2, Kampo Kihatsu No. 031121002, 2003)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Remarks:
- Gas chromatography-mass spectrometry (GC/MS)
- Details on sampling:
- The test substance deteriorates by light, therefore, sampling was done under yellow lamp, at the preparation of stock solution. For all test groups, test solution was sampled from one test vessel for analysis.
- Vehicle:
- no
- Details on test solutions:
- Stock solution (concentration of 60 mg/L) was prepared by diluting the test chemical with water using ultrasonic treatment (3 minutes). Test chemical was stored at room temperature, darkness and light-interception. IR absorption spectrum of the chemical was measured at the start and the end of the test, and both spectra were not contradictory to each other.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- - Common name: water flea
- Age at study initiation: less then 24 hours old.
- Supplier/Source: Test organism was obtained from National Institute of Environmental Studies (Japan) and had been reproduced in testing laboratory.
- Pretreatment: Parental daphnids were acclimated for 23 days on test condition before testing. Daphnids were fed with Chlorella vulgaris, 0.2 mg carbon/day/individual. During acclimatization, mortality of parental daphnia was 0 % and resting eggs and males were not shown.
- Feeding during test: none - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 250 mg/L as CaCO3
- Test temperature:
- 20.0 - 20.4 °C
- pH:
- 8.2 – 8.4
- Dissolved oxygen:
- 60 % above saturation, 8.3 - 8.8 mg/L
- Nominal and measured concentrations:
- Nominal Concentrations: control, 1.50, 2.70, 4.80, 8.40, and 15.0 mg/L
Time-weighted Mean Concentrations (TWA): control, 0.77, 1.29, 3.11, 5.70 and 9.65 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Type: covered water surface with PTFE sheet to avoid evaporation of test solutions and volatilization of test substance (closed system)
- Material, size, headspace, fill volume: 100 mL glass beaker
- Volume of solution: 100 mL
- Aeration: no
- Renewal rate of test solution: every 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 medium
OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16 h light / 8 h dark
- Light intensity: less than 800 lux
VEHICLE CONTROL PERFORMED: no
RANGE-FINDING STUDY
- Test concentrations: 1st test: 0.577, 5.77, 57.7 mg/L; 2nd test - 2, 5, 12, 30 mg/L
- Results used to determine the conditions for the definitive study: 1st test - 20 % immobilisation at 5.77 mg/L and 100% immobilisation at 57.7 mg/L after 48 h; 2nd test - 10 % immobilisation at 5 mg/L and 100 % immobilisation at 12 and 30 mg/L after 48 h. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.11 mg/L
- Nominal / measured:
- meas. (TWA)
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CI: 1.29 – 5.70 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 1.29 mg/L
- Nominal / measured:
- meas. (TWA)
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 5.7 mg/L
- Nominal / measured:
- meas. (TWA)
- Basis for effect:
- mobility
- Details on results:
- The ratio of measured concentration to nominal concentration of the test solutions at the test solution preparation was 47 - 73%, and 38 - 66% after 24 hours. The main cause of the decrease was assumed to be due to the volatilization from water.
In the control, the percent immobility during the exposure was 0%, and no trapping daphnids were observed on the water surface, satisfying the criterion for the validity of the test.
The 24-h EC50 was determined to be 3.94 mg/L (95 % CI: 3.11 - 5.70 mg/L). - Results with reference substance (positive control):
- The EC50 (48 hr, immobility) for the reference substance was 0.75 mg/L.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50 after 48-h exposure was determined to be 3.11 mg/L.
- Executive summary:
In the acute immobilisation test with Daphnia magna, the effects of the test item were determined according to OECD 202. The study was conducted in a semi-static system over a period of 48 hours with a renewal of the test medium after 24 hours. The following concentrations were tested - control, 1.50, 2.70, 4.80, 8.40, and 15.0 mg/L. 20 daphnids per test concentration and control were tested. The test item concentration was determined at the start and at the end of each renewal period GC-MS. As the concentrations differed with more than ± 20 % to the nominal concentration, time-weighted mean (TWA) concentrations were calculated and biological endpoints were based on the TWA concentrations. The validity criteria of the test guideline were fulfilled. Immobilisation of the daphnids was observed in the preliminary tests. After 48-h exposure 50 % immobilization was observed at concentration level 3.11 mg/L and 100 % at 8.40 mg/L. Therefore, the estimated EC50 value (48 hours) of the test item is 3.11 mg/L.
Reference
Test substance concentration in test solutions
The ratio of measured concentration to nominal concentration was 47 - 73% at the test solution preparation, and 38 - 66% after 24 hours. The main cause of the decrease was assumed to be due to the volatilization from water.
0.1 mL acetone was added to 10 mL of analytical sample (test solutions were diluted by purified water; by two times for 1.50 mg/L group, by five times for 2.70 and 4.80 mg/L groups, by 10 times for 8.40 mg/L group and 20 times for 15.0 mg/L group), mixed and analyzed by using GC/MS.
Table 1. Concentration of the Test Substance in the test medium
Nominal Conc. (mg/L) |
Measured Concentration (mg/L) (Percent of Nominal, %) |
Time-weighted Mean* Conc. (mg/L) |
|||
0 h (new) |
24 h (old) |
24 h (new) |
48 h (old) |
||
Control |
- |
- |
- |
- |
- |
1.50 |
0.816 (54) |
0.686 (46) |
0.826 (55) |
0.767 (51) |
0.770 (51) |
2.70 |
1.26 (47) |
1.02 (38) |
1.53 (57) |
1.37 (51) |
1.29 (48) |
4.80 |
3.35 (70) |
2.75 (57) |
3.28 (68) |
3.08 (64) |
3.11 (65) |
8.40 |
5.87 (70) |
5.38 (64) |
5.98 (71) |
5.58 (66) |
5.70 (68) |
15.0 |
11.0 (73) |
8.98 (60) |
10.0 (67) |
8.72 (58) |
9.65 (64) |
* as described in OECD TG 211
Table 2. The numbers of Immobile Daphnia magna (Percent Immobility)
Nominal Conc. (mg/L) |
Mean Measured Conc. (TWA) (mg/L) |
Cumulative Number of Immobilised Daphnia (Percent Immobility, %) |
|
0hour |
48 hours |
||
Control |
- |
0 (0) |
0 (0) |
1.50 |
0.770 |
0 (0) |
0 (0) |
2.70 |
1.29 |
0 (0) |
0 (0) |
4.80 |
3.11 |
2 (10) |
10 (50) |
8.40 |
5.70 |
20 (100) |
20 (100) |
15.0 |
9.65 |
20 (100) |
20 (100) |
Description of key information
The EC50 after 48-h exposure was determined to be 3.11 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 3.11 mg/L
Additional information
In the acute immobilisation test with Daphnia magna, the effects of the test item were determined according to OECD 202 (reference 6.1.3-1). The study was conducted in a semi-static system over a period of 48 hours with a renewal of the test medium after 24 hours. The following concentrations were tested - control, 1.50, 2.70, 4.80, 8.40, and 15.0 mg/L. 20 daphnids per test concentration and control were tested. The test item concentration was determined at the start and at the end of each renewal period GC-MS. As the concentrations differed with more than ± 20 % to the nominal concentration, time-weighted mean (TWA) concentrations were calculated and biological endpoints were based on the TWA concentrations. The validity criteria of the test guideline were fulfilled. Immobilisation of the daphnids was observed in the preliminary tests. After 48 h exposure 50 % immobilization was observed at concentration level 3.11 mg/L and 100 % at 8.40 mg/L. Therefore, the estimated EC50 value (48 hours) of the test item is 3.11 mg/L.
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.