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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 277-288-1 | CAS number: 73138-39-3
- 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:
- 02 - 04 Nov 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- Apr 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD monograph No. 23
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Secrétariat général du GIPC, Ivry-sur-Seine, Cedex, France (15 Nov 2018)
- Analytical monitoring:
- yes
- Remarks:
- GC-MS/MS
- Details on sampling:
- - Concentrations: Control, 0.88, 1.94, 4.27, 9.39, 20.66, 45.45 and 100 mg/L (after 0 and 48 h)
- Sample storage conditions before analysis: Samples were immediately analysed. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was poorly soluble under the test conditions. Therefore, the test solutions were prepared as Water Accommodated Fractions (WAF) according to OECD guideline 23. The WAFs were prepared individually. The respective test item amounts were directly added to the test medium and mixed for 72 h to achieve an equilibrated concentration of dissolved and dispersed or emulsified components in the aqueous phase.
- Differential loading: Yes
- Controls: Test medium only, without test item.
- Evidence of undissolved material: Since the test solutions were not filtered, the test solutions were therefore emulsions of the test element. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Clone 5
- Source: bred at test laboratory
- Age at test start: Between 6 and 24 h old, produced from parthenogenically reproducing brood female population
- Breeding conditions: Juveniles were selected daily by filtration. The juveniles from at least the 2nd litter were used for the test. Culture medium: Elendt M4; Temperature: 20 ± 2 °C; Lighting: 16 h light/8 h dark; pH: 6 - 9; CaCO3 concentration: 140 - 250 mg/L; Feeding: Daily; Food type: Pseudokirchneriella subcapitata and Chlorella vulgaris suspensions - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 140 - 250 mg/L CaCO3 (Elendt M4 medium)
- Test temperature:
- 20 ± 2 °C
- pH:
- 7.4 - 8.0
- Dissolved oxygen:
- 7.4 - 8.8 mg/L
- Nominal and measured concentrations:
- Control, 0.88, 1.94, 4.27, 9.39, 20.66, 45.45 and 100.30 mg/L (nominal loading rates of WAF, for analytical results see field any other information on results incl. tables)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL glass flasks filled with 50 mL test solution
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The test medium used was OECD medium, prepared according to OECD guideline 202. It was reconstituted with chemical reagents and deionised water.
OTHER TEST CONDITIONS
- Adjustment of pH: Between 6 and 9
- Photoperiod: 16 h light/ 8 h dark
- Light intensity: 231-235 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mobility after 24 and 48 h
RANGE-FINDING STUDY
- Test concentrations: nominal loading rates: 1, 10, 100, mg/L (WAF)
- Results used to determine the conditions for the definitive study: 100% immobiliatiosation at a loading rate of 100 mg/L (WAF) - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- 37.59 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% confidence interval: 34.59 - 40.98 mg/L
- Details on results:
- - Behavioural abnormalities: None
- Other biological observations: None
- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test item was poorly soluble and test solutions were prepared as Water Accommodated Fractions (WAFs). However, chemical analysis detected very low amounts of test item in the WAFs.
- Effect concentrations exceeding solubility of substance in test medium: Yes - Results with reference substance (positive control):
- EC50 (24 h): 1.851 mg/L (95% confidence limits: 1.753 – 1.948 mg/L, starting date19 September 2018)
- Reported statistics and error estimates:
- The probits method was used to estimate the EC50 after 24 and 48 h.
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Reference
BIOLOGICAL RESULTS
Table 1: Immobilized Daphnids after 24 and 48 h.
Loading rate [mg/L] |
Immobilized Daphnids |
|
24 h |
48 h |
|
0 |
0 |
0 |
0.88 |
0 |
0 |
1.94 |
0 |
0 |
4.27 |
0 |
0 |
9.39 |
0 |
0 |
20.66 |
0 |
1 |
45.45 |
9 |
14 |
100 |
16 |
20 |
VALIDITY CRITERIA
The study fulfilled the validity criteria defined by the guideline and is thus considered valid and reliable (Table 1).
Table 2: Validity criteria for OECD 202.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized. |
Actual value: 0% |
Yes |
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels. |
Actual value: 7.8 mg/L |
Yes |
ANALYTICAL RESULTS
Analytical findings are summarized in Table 2.
Table 2. Analytical results.
|
|
Nominal loading rate [mg/L] |
|||||||
Time |
Analyte |
0 |
0.88 |
1.94 |
4.27 |
9.39 |
20.66 |
45.45 |
100 |
0 h |
[mg monoester/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
[mg diester/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
1.13 |
2.08 |
|
[mg diester2/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
0.90 |
1.32 |
|
[mg diester3/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
0.95 |
|
[mg diester4/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
0.82 |
|
48 h |
[mg monoester/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
[mg diester/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
1.23 |
2.64 |
|
[mg diester2/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
0.75 |
1.68 |
|
[mg diester3/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
1.04 |
|
[mg diester4/L] |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
0.99 |
Limit of Quantification (LOQ) = 3.02 mg/L for monoester
LOQ = 0.52 mg/L for diester1
LOQ = 0.73 mg/L for diester2
LOQ = 0.79 mg/L for diester3
LOQ = 0.74 mg/L for diester4
BIOLOGICAL RESULTS
Based on the number of immobilized daphnids, the derived EC50 after 24 h was 51.56 mg/L (95% confidence limits: 42.88 – 60.25 mg/L) and the derived EC50 after 48 h was 37.59 mg/L (95% confidence limits: 34.59 – 40.98 mg/L).
Description of key information
EL50 (48 h) = 37.59 mg/L (nominal loading rate, OECD 202)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 37.59 mg/L
Additional information
One study is available testing the toxicity of the substance towards aquatic invertebrates. The study was conducted according to the OECD guideline 202 and GLP standards. Daphnia magna was used as the test organism and was exposed in a static testing regime to nominal loading rates of 0.88, 1.94, 4.27, 9.39, 20.66, 45.45 and 100 mg/L for 48 h. Since the substance fulfils the UVCB criteria and is partly poorly water soluble the test solutions were prepared as water-accommodated fractions (WAF). The test item quantification was performed by GC-MS/MS at 0 and 48 h. The analytical recovery of the constituents was mostly below the quantification limit. The test resulted in an EL50 (48 h) of 37.59 mg/L (nominal loading rates). All validity criteria were met and the study is considered valid.
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.