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EC number: 915-926-9 | 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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-11-11 to 2013-01-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- adopted October 03, 2008.
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.20 (Daphnia magna Reproduction Test)
- Version / remarks:
- May 30, 2008
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Sampling: One sample from the freshly prepared stock solution and duplicate samples from the freshly prepared test media of all test concentrations and the control were taken at the first treatment period (Day 0) and at a treatment period in the second and third week (Days 10 and 17). For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the renewal periods, duplicate samples of the respective aged test media and controls were sampled at Day 3, 12 and 19. One of these three stability control treatments lasted for 72 hours (weekend), two for 48 hours, corresponding to the different test medium renewal periods.
Analyses: The concentration of the test item Humectol C liq hc was only measured in the highest test concentration of nominal 2 mg/L in all duplicate test medium samples from all sampling times. The other test media were not analysed, since they were below the NOEC determined in this test. From the control samples only one of the duplicate samples was analysed from each sampling date. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
A stock solution was prepared by dissolving 22.2, 23.3, 20.1, 20.8, 20.6, 21.0, 21.8, 20.3 and 20.0 mg test item into 555, 582.5, 502.5, 520, 515, 525, 545, 507.5 and 500 mL test water respectively by intense stirring for 10 minutes. Adequate volumes of this test medium were diluted with test water to prepare the test medium. The appearance of the test item in the test media was determined at each test medium renewal period in the freshly prepared and aged test media of all test concentrations. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Straus / Clone 5
- Justification for species other than prescribed by test guideline: according to guideline
- Stage and instar at study initiation: 4.25 to 21.75 hours old
- Source: IBACON in-house laboratory culture
- Feeding during test: yes
- Food type: green algae (Desmodesmus subspicatus)
- Amount: based on the concentration of total organic carbon (TOC) in the algal food suspension. The approximate daily amounts of algal TOC/Daphnia were as follows:
Days 0-3: 0.1 mg
Days 4-7: 0.15 mg
Days 8-20: 0.2 mg
ACCLIMATION
- Acclimation conditions (same as test or not): same - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 2.5 mmol/L (= 250 mg/L) as CaCO3
- Test temperature:
- 19 - 21 °C in the freshly prepared media;
19 - 21 °C in the aged media - pH:
- 7.4 to 8.3 in the freshly prepared media;
7.4 to 8.5 in the aged media; and thus the pH-value did not vary by more than 1.5 units - Dissolved oxygen:
- 7.7 to 9.7 mg/L in the freshly prepared media;
8.1 to 10.8 mg/L in the aged media - Nominal and measured concentrations:
- Nominal: 2.0, 0.633, 0.2, 0.063 and 0.02 mg test item/L and a control.
Measured: Within ± 20 % of the nominal - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass beaker
- Material, size, fill volume: glass beaker, 100 mL, 60 mL
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: reconstituted water (Elendt "M4")
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light: 8 h dark.
- Light intensity: 1050 - 1360 lux.
EFFECT PARAMETERS MEASURED
Mortality of Adults and Number of Young: The mortality of the test animals and the number of young daphnids were recorded for each day. Dead animals and offspring were removed at the same times. - Reference substance (positive control):
- not required
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Survival
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Survival
- Details on results:
- Biological Results
Reproduction:
21-day NOEC 2.0 mg test item/L
21-day LOEC > 2.0 mg test item/L
21-day EC50 (95 % CI) > 2.0 mg test item/L (n.d.)
21-day EC20 (95 % CI) > 2.0 mg test item/L (n.d.)
21-day EC10 (95 % CI) > 2.0 mg test item/L (n.d.)
CI: Confidence interval
n.d.: Not determinable
Survival:
21-day NOEC 2.0 mg test item/L
21-day LOEC > 2.0 mg test item/L
Survival of Adults: At the test item concentrations of 0.02 and 0.063 mg test item/L, all Daphnia survived until the end of the test. In the control and the test item concentrations of 0.2 to 2.0 mg test item/L, one Daphnia died until the end of the test. Thus, the survival rate of Daphnia magna after 21 days was not significantly reduced in any test concentration.
Reproduction: The total numbers of live offspring produced by all surviving adults for each treatment group and the reproduction is given in Table 1. The reproduction of those Daphnia in the control was 147 ± 30 (mean ± SD) live offspring per adult. The coefficient of variation around the mean number of living offspring produced per parent animal in the control was 20.4 %. According to the results of a Williams-test (one-sided, = 0.05), the lowest concentration showed a significant inhibition when compared to the control. However, since all test concentrations above the LOEC must have a harmful effect equal to or greater than those observed at the LOEC, and all higher test concentration showed no significant effect, this significance was deemed not to be treatment related. Therefore, no significant toxic effect of the test item on the mean reproduction was determined up to and including the highest nominal test concentration of 2.0 mg test item/L. The EC50 of the reproduction was determined to be > 2.0 mg test item/L.
Date of First Brood: The first young Daphnia released from their parent animals were recorded in the nominal test concentrations of 0.633 and 2.0 mg test item/L at the observation on day 8. In the control and the nominal test item concentrations up to and including 0.2 mg test item/L, the first offspring was recorded at the observation on day 9.
Signs of Intoxication: No particular signs of intoxication were observed at the test animals during the test.
Appearance of the Test Item in the Test Media: No remarkable observations. - Reported statistics and error estimates:
- The NOEC and the LOEC for the reproduction and survival were evaluated by the Williams Multiple Sequential t-test and the Fisher's exact, respectively. The EC50, EC20 and EC10 of the reproduction could not be calculated due to absence of toxicity of the test item. The software used to perform the statistical analysis was ToxRat Professional, Version 2.10.05, ToxRat® Solutions GmbH.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The influence of the test item on the survival and reproduction of Daphnia magna was determined during an exposure period of 21 days. The 21 day NOEC was determined to be 2.0 mg test item/L for the reproduction and for the survival of the adult test animals. The 21-day EC50 for the reproduction was > 2.0 mg test item/L.
- Executive summary:
The purpose of this study was to evaluate the toxicity of the test item on the survival and reproduction of Daphnia magna during an exposure period of 21 days according to OECD TG 211 and EU Method C.20. Young Daphnia (< 24 hours old) were exposed in a semi-static test to aqueous test media containing the test item at various concentrations. The study encompassed 5 test concentrations and one control with 10 replicates (2.0, 0.633, 0.2, 0.063 and 0.02 mg test item/L and a control), each containing one Daphnia. A semi-static test was performed. The mortality rate, the reproduction and symptoms of intoxication were compared with corresponding parameters in the control. The quantification of the test item was performed using liquid chromatography (LC-MS-method). In the freshly prepared test media 95 % of the nominal test concentration was found in case of measurement of masses 492.3 and 394.6. In the aged test media 78 % (mass 492.3) and 82 % (mass 394.6) was found (mean values of nominal 2 mg/L, respectively). Correct dosing of the test item could be demonstrated. Therefore, all biological endpoints were based on nominal test concentrations. The purpose of the analytical part of this study was to verify the concentrations of the test item in the test medium. All validity criteria were met. The 21-day NOEC was determined to be 2.0 mg test item/L for the reproduction and for the survival of the adult test animals. The 21-day EC50 for the reproduction was > 2.0 mg test item/L.
Reference
Table 1: Number of Surviving Adult Daphnia magna Exposed to Test Item
Exposure Day |
Nominal concentration [mg test item/L] |
|||||
Control |
0.02 |
0.063 |
0.2 |
0.633 |
2.0 |
|
0 |
10 |
10 |
10 |
10 |
10 |
10 |
1 |
10 |
10 |
10 |
10 |
10 |
10 |
2 |
10 |
10 |
10 |
10 |
10 |
10 |
3 |
10 |
10 |
10 |
9 |
10 |
10 |
4 |
10 |
10 |
10 |
9 |
10 |
10 |
5 |
10 |
10 |
10 |
9 |
10 |
10 |
6 |
10 |
10 |
10 |
9 |
10 |
10 |
7 |
10 |
10 |
10 |
9 |
10 |
10 |
8 |
10 |
10 |
10 |
9 |
10 |
10 |
9 |
10 |
10 |
10 |
9 |
10 |
10 |
10 |
10 |
10 |
10 |
9 |
10 |
10 |
11 |
9 |
10 |
10 |
9 |
10 |
9 |
12 |
9 |
10 |
10 |
9 |
10 |
9 |
13 |
9 |
10 |
10 |
9 |
10 |
9 |
14 |
9 |
10 |
10 |
9 |
10 |
9 |
15 |
9 |
10 |
10 |
9 |
9 |
9 |
16 |
9 |
10 |
10 |
9 |
9 |
9 |
17 |
9 |
10 |
10 |
9 |
9 |
9 |
18 |
9 |
10 |
10 |
9 |
9 |
9 |
19 |
9 |
10 |
10 |
9 |
9 |
9 |
20 |
9 |
10 |
10 |
9 |
9 |
9 |
21 |
9 |
10 |
10 |
9 |
9 |
9 |
% surviving |
- |
111 |
111 |
100 |
100 |
100 |
Table 2: Number of Live Offspring Produced by all Surviving Adults within 21 Days of Exposure (Cumulative Values)
Exposure Day |
Nominal concentration [mg test item/L] |
||||||
Control |
0.02 |
0.063 |
0.2 |
0.633 |
2.0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8 |
0 |
0 |
0 |
0 |
31 |
18 |
|
9 |
129 |
120 |
115 |
43 |
108 |
142 |
|
10 |
129 |
120 |
115 |
135 |
142 |
142 |
|
11 |
129 |
120 |
137 |
135 |
241 |
239 |
|
12 |
376 |
387 |
352 |
223 |
436 |
405 |
|
13 |
376 |
387 |
380 |
379 |
436 |
441 |
|
14 |
376 |
387 |
380 |
423 |
638 |
605 |
|
15 |
624 |
729 |
734 |
469 |
881 |
778 |
|
16 |
624 |
729 |
773 |
606 |
935 |
778 |
|
17 |
636 |
729 |
773 |
705 |
1026 |
967 |
|
18 |
984 |
1059 |
1133 |
837 |
1306 |
1197 |
|
19 |
984 |
1059 |
1133 |
912 |
1306 |
1260 |
|
20 |
984 |
1059 |
1178 |
1095 |
1360 |
1424 |
|
21 |
1321 |
1213 |
1387 |
1183 |
1694 |
1581 |
|
No. of surviving adults |
9 |
10 |
10 |
9 |
9 |
9 |
|
Average number of offspring per surviving adult |
146.8 |
121.3 |
138.7 |
131.4 |
188.2 |
175.7 |
|
Table 3: Total Number of Live Immature Daphnia Produced by All Adults (Cumulative Values)
Exposure Day |
Nominal concentration [mg test item/L] |
|||||
Control |
0.02 |
0.063 |
0.2 |
0.633 |
2.0 |
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
0 |
0 |
31 |
18 |
9 |
143 |
120 |
115 |
43 |
122 |
155 |
10 |
143 |
120 |
115 |
135 |
156 |
155 |
11 |
143 |
120 |
137 |
135 |
292 |
252 |
12 |
390 |
387 |
352 |
223 |
487 |
418 |
13 |
390 |
387 |
380 |
379 |
487 |
454 |
14 |
390 |
387 |
380 |
423 |
736 |
618 |
15 |
638 |
729 |
734 |
469 |
979 |
791 |
16 |
638 |
729 |
773 |
606 |
1033 |
791 |
17 |
650 |
729 |
773 |
705 |
1124 |
980 |
18 |
998 |
1059 |
1133 |
837 |
1404 |
1210 |
19 |
998 |
1059 |
1133 |
912 |
1404 |
1273 |
20 |
998 |
1059 |
1178 |
1095 |
1458 |
1437 |
21 |
1335 |
1213 |
1387 |
1183 |
1792 |
1594 |
% of control |
- |
90.9 |
103.9 |
88.6 |
134.2 |
119.4 |
Table 4: Number of Live Immature Daphnia produced by each surviving Adult after 21 Days
Nominal concentration [mg test item/L] |
||||||
Replicate |
Control |
0.02 |
0.063 |
0.2 |
0.633 |
2.0 |
1 |
- |
144 |
134 |
83 |
191 |
196 |
2 |
178 |
116 |
117 |
135 |
205 |
158 |
3 |
131 |
113 |
124 |
124 |
176 |
166 |
4 |
137 |
0 |
161 |
- |
182 |
- |
5 |
169 |
145 |
127 |
136 |
190 |
167 |
6 |
168 |
165 |
158 |
123 |
- |
190 |
7 |
113 |
146 |
158 |
176 |
161 |
201 |
8 |
179 |
140 |
163 |
154 |
222 |
168 |
9 |
95 |
122 |
106 |
130 |
191 |
163 |
10 |
151 |
122 |
139 |
122 |
176 |
172 |
mean |
146.8 |
121.3 |
138.7 |
131.4 |
188.2 |
175.7 |
SD |
29.9 |
45.7 |
20.4 |
25.2 |
17.7 |
15.7 |
CV |
20.4 % |
37.6 % |
14.7 % |
19.2 % |
9.4 % |
8.9 % |
% of control |
- |
82.6* |
94.5 |
89.6 |
128.2 |
119.7 |
[Williams t_test, a = 0.05; * = significant]
_ = adult died in the course of the study
Table 5: Summary of Analytical Results
Sample description [mg test item/L] |
Mass 492.3 |
Mass 394.6 |
||
% of nominal1 |
RSD [%] |
% of nominal1 |
RSD [%] |
|
control |
n.a. |
n.a. |
n.a. |
n.a. |
2 |
85 |
11 |
87 |
10 |
1mean value of all measured samples per treatment group
RSD: relative standard deviation per treatment group
n.a.: not applicable
n: number of analysed samples
Description of key information
The toxicity of the test item on the survival and reproduction of Daphnia magna was determined during an exposure period of 21 days. The 21 day NOEC was determined to be 2.0 mg test item/L for the reproduction and for the survival of the adult test animals. The 21-day EC50 for the reproduction was > 2.0 mg test item/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 2 mg/L
Additional information
The purpose of this study was to evaluate the toxicity of the test item on the survival and reproduction of Daphnia magna during an exposure period of 21 days according to OECD TG 211 and EU Method C.20. Young Daphnia (< 24 hours old) were exposed in a semi-static test to aqueous test media containing the test item at various concentrations. The study encompassed 5 test concentrations and one control with 10 replicates (2.0, 0.633, 0.2, 0.063 and 0.02 mg test item/L and a control), each containing one Daphnia. A semi-static test was performed. The mortality rate, the reproduction and symptoms of intoxication were compared with corresponding parameters in the control. The quantification of the test item was performed using liquid chromatography (LC-MS-method). In the freshly prepared test media 95 % of the nominal test concentration was found in case of measurement of masses 492.3 and 394.6. In the aged test media 78 % (mass 492.3) and 82 % (mass 394.6) was found (mean values of nominal 2 mg/L, respectively). Correct dosing of the test item could be demonstrated. Therefore, all biological endpoints were based on nominal test concentrations. The purpose of the analytical part of this study was to verify the concentrations of the test item in the test medium. All validity criteria were met. The 21-day NOEC was determined to be 2.0 mg test item/L for the reproduction and for the survival of the adult test animals. The 21-day EC50 for the reproduction was > 2.0 mg test item/L.
The reported effect concentrations refer to the commercial formulation containing 46.2% (w/w) of the REACH registration substance which reflects the test item used in the 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.
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