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EC number: 915-318-3 | CAS number: -
- 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:
- 17 Nov 2017 - 19 Dec 2017
- 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)
- Version / remarks:
- April 13, 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: WAFs prepared at individual loading rates of 10, 18, 32, 56 and 100 mg/L.
- Sampling method: Samples for possible analysis were taken from all test concentrations and the control at t=0 h and t=48 h. 4.0 mL was taken from the approximate centre of the test vessels.
- Sample storage conditions before analysis: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
- At the end of the exposure period, the replicates were not pooled at each concentration before sampling. Instead, samples were taken from one replicate per concentration for all test concentrations. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with loading rates individually prepared ranging between 1.0 and 100 mg/L. A three-day period of magnetic stirring was applied to ensure maximum dissolution of the test item in medium. The obtained mixtures were allowed to settle for a period of one hour. Thereafter, the aqueous Water Accommodated Fractions (WAFs) were collected by means of siphoning and used as test concentrations. All test solutions were clear and colorless at the end of the preparation procedure.
- Controls: Test medium without test item or other additives - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Straus 1820.
- Source: In-house laboratory culture with a known history
- Age of parental stock: > 2 weeks
- Age at test initiation: <24 h
- Feeding during test: no
BREEDING
- Start of each batch: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel.
- Maximum age of the cultures: 4 weeks
- Renewal of the cultures: After 7 days of cultivation half of the medium twice a week.
- Temperature of medium: 18-22°C
- Feeding: Daily, a suspension of fresh water algae.
- Culture medium: M7 - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 180 mg/L CaCO3
- Test temperature:
- 19 - 20°C
- pH:
- At t=0 h: 7.9
At t=48 h: 8.1-8.2 - Dissolved oxygen:
- At t=0 h: 8.4-9.1 mg/L
At t=48 h: 7.8-8.3 mg/L - Nominal and measured concentrations:
- Nominal: WAFs prepared at individual loading rates of 10, 18, 32, 56 and 100 mg/L.
Measured: At t=0 h: 9.6, 12, 13, 38 and 48 mg/L. The measured concentration remained stable throughout the test, i.e. were 95 - 106% relative to initial. Based on these results, effect parameters were expressed as measured initial concentrations. See Table 3 in 'Any other information on results' for measured concentrations for all samples throughout the test. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 50 mL, all-glass, airtight closed with no headspace
- Aeration: no
- No. of organisms per vessel: 5 daphnids
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium, prepared with tap water purified by Reverse Osmosis
- Culture medium different from test medium: yes
- Intervals of water quality measurement: pH and dissolved oxygen: at the beginning and at the end of the test, for all concentrations and the control. Temperature of medium: continuously in a temperature control vessel, beginning at the start of the test.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily
EFFECT PARAMETERS MEASURED
- Immobility (including mortality): at 24 hours and at 48 hours.
RANGE-FINDING STUDY
- Test concentrations: Control, WAFs prepared individually at 1.0, 10 and 100 mg/L.
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (performed Jan 2018)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 11 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% confidence interval: 8.7-13 mg/L
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- < 96 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 9.6 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Details on results:
- No biologically significant immobility was observed in the control throughout the exposure period. After 24 hours of exposure, all daphnids were immobilized in the measured concentrations of 38 and 48 mg/L. At the end of the test, a dose-related increase of immobility was observed at all test concentrations.
- Results with reference substance (positive control):
- - Results with reference substance valid?
yes
- Relevant effect levels: The 48h-EC50 was 0.54 mg/L with a 95% confidence interval between 0.49 and 0.61 mg/L. The responses in this reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations, i.e. the 48h-EC50 was between 0.3 and 1.0 mg/L. Hence, the sensitivity of this batch of D. magna was in agreement with the historical data collected at Charles River Den Bosch. - Reported statistics and error estimates:
- 48h-EC50-value was calculated from the weibits of the percentages of affected daphnids and the logarithms of the corresponding test item concentrations (initially measured) using the maximum likelihood estimation method. ToxRat Professional v 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analysis.
- Validity criteria fulfilled:
- yes
- Remarks:
- See 'Overall remarks' for details on validity criteria.
- Conclusions:
- The 48h-EC50 for Daphnia magna exposed to POLYAMBROL was 11 mg/L based on measured concentrations (95% confidence interval between 8.7 and 13 mg/L).
- Executive summary:
In a 48 h acute toxicity test conducted according to OECD guideline 202, Daphnia magna were exposed to Water Accommodated Fractions of the test item individually prepared at 10, 18, 32, 56 and 100 mg/L. Initial measured concentrations were 9.6, 12, 13, 38 and 48 mg/L, and remained stable throughout the test duration (i.e. 95 -106% relative to initial). Therefore, effect parameters were expressed as initial measured concentrations. No biologically significant immobility or other effects were observed in the control. After 24 h of exposure, all daphnids were immobilized in the measured concentrations of 38 and 48 mg/L. At the end of the test, a dose-related increase of immobility was observed at measured concentrations of 9.6 mg/L and higher. The 48h-EC50 for immobility was calculated to be 11 mg/L (95% confidence interval 8.7 -13 mg/L), the NOEC was < 9.6 mg/L, and the LOEC was 9.6 mg/L. The study is considered to be reliable without restrictions.
Reference
Table 2: Number of Introduced Daphnids and Incidence of Immobility
in the Final Test
Time (h) |
Replicate |
POLYAMBROL; Measured concentration (mg/L) |
|||||
Control |
9.6 |
12 |
13 |
38 |
48 |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
5 |
5 |
5 |
5 |
5 |
|
D |
5 |
5 |
5 |
5 |
5 |
5 |
|
Total introduced |
20 |
20 |
20 |
20 |
20 |
20 |
|
24 |
A |
0 |
0(5) |
0(2) |
0 |
5 |
5(4) |
B |
0 |
0(3) |
0(3) |
0 |
5 |
5 |
|
C |
0 |
1 |
0 |
0 |
5 |
5 |
|
D |
0 |
0 |
0 |
0 |
5 |
5 |
|
Total immobilised |
0 |
1 |
0 |
0 |
20 |
20 |
|
Effect % |
0 |
5 |
0 |
0 |
100 |
100 |
|
|
|
|
|
|
|
||
48 |
A |
0 |
0(1) |
1 |
4 |
5 |
5 |
B |
0(1) |
3# |
3 |
3 |
5 |
5 |
|
C |
0 |
2 |
2 |
5 |
5 |
5 |
|
D |
0 |
2 |
3 |
5 |
5 |
5 |
|
Total immobilised |
0 |
7 |
9 |
17 |
20 |
20 |
|
Effect % |
0 |
35 |
45 |
85 |
100 |
100 |
( ) between brackets: number of daphnids observed trapped at the surface of the test solutions. These organisms were reimmersed into the respective solutions before recording of mobility.
#Microscopic observation revealed no test item attached to the daphnids.
Table 3: Final Test: Test Samples
Time of sampling |
Date of sampling |
Date of |
Loading rate2 |
Concentration |
Relative to |
0 |
11 Dec 2017 |
18 Dec 2017 |
0 |
n.d. |
|
|
|
|
10 |
9.55 |
|
|
|
|
18 |
11.8 |
|
|
|
|
32 |
12.9 |
|
|
|
|
56 |
37.9 |
|
|
|
|
100 |
48.2 |
|
48 |
13 Dec 2017 |
18 Dec 2017 |
0 |
n.d. |
n.a. |
|
|
|
10 |
9.10 |
95 |
|
|
|
18 |
11.4 |
97 |
|
|
|
32 |
13.1 |
102 |
|
|
|
56 |
39.0 |
103 |
|
|
|
100 |
50.9 |
106 |
1 Samples were stored in the freezer (≤ -15°C) until the day of analysis.
2 Awater accommodated fraction (WAF)prepared at the loading rate.
n.d. Not detected.
n.a. Not applicable
Description of key information
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 11 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.
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