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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 216-032-5 | CAS number: 1477-55-0
- 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:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted guidelines. OECD Guideline 211. No deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Sampling was conducted every 24 hours
- Vehicle:
- no
- Details on test solutions:
- Nominal concentrations: Control, 0.150, 0.470, 1.50, 4.70, 15.0 mg/L
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- No data
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Post exposure observation period:
- No data
- Hardness:
- 195-255 mg/L of calcium carbonate - see Table 11 (attached)
- Test temperature:
- 20 ± 1 degrees Centigrade - see Table 8 (attached)
- pH:
- pH 7.4 - 8.8 - see Table 10 (attached)
- Dissolved oxygen:
- 7.5 - 8.8 mg/L - see Table 9 (attached)
- Salinity:
- No data
- Nominal and measured concentrations:
- Nominal concentrations: control, 0.150, 0.470, 1.50, 4.70, 15.0 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type: closed with the surace of the water covered with a teflon sheet
- Fill volume: 80 mL
- Renewal rate of test solution: Every 24 hours
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of individuals per dose level: 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 medium - see Table A-1 (attached)
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: 800 lux
EFFECT PARAMETERS MEASURED: Mortality and reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 4.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 15 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 8.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: Unable to calculate 95% confidence limit
- Duration:
- 21 d
- Dose descriptor:
- LC50
- Effect conc.:
- 6.77 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: 95% confidence limit 1.5 - 15.0 mg/L
- Details on results:
- All of the measured concentrations of the test material were within ± 20 % of nominal concentrations, therefore, the nominal concentrations were used for calculation of effect concentration. Representative chromatograms are attached.
No environmental factors which might affect the reliability of the study results were seen.
The mortality of parental Daphnia in the control group was 0 % at the end of the exposure period, and this result fulfilled the validation criteria for the study (20 % or less). The mortality in the highest concentration group was 100 % at the end of the exposure period.
First brood production by parent Daphnia in the control group took place on Day 8 after the start of exposure, which was considered to be within the normal range. All parental Daphnia in the highest concentration group died before first brood production.
Mean cumulative numbers of juveniles produced per one parent Daphnia during 21 days in the control group were 108 animals, and this fulfilled the validation criteria of the study (60 animals). All parental Daphnia in the highest concentration group died before first brood production.
Generation of dormant broods was not observed in the control group or any test concentration group during the exposure period.
The temperatures of the test solutions were 20 ± 1 degrees Centigrade in all concentration groups, and dissolved oxygen concentrations were 60 % or more of the saturated concentration (at 20 degrees Centigrade: 8.8 mg/L). Both of these values fulfilled the study standards. The pH values were within the appropriate range (6.0 ~ 9.0 with a variation of 1.5) for raising Daphnia. In addition, the hardness was considered to be within the appropriate range (approximately 250 mg/L). - Validity criteria fulfilled:
- yes
- Conclusions:
- The median lethal concentration of parent Daphnia (LC50) was determined to be 6.77 mg/L with a 95 % confidence limit of 1.50 ~ 15.0 mg/L.
The 50% reproduction inhibition concentration (EC50) was determined as 8.40 mg/L although the confidence limit could not be calculated.
The maximum No Observed Effect Concentration (NOEC) was calculated as 4.70 mg/L and the Lowest Observed Effect Concentration (LOEC) was calculated as 15.0 mg/L.
Reference
The results of test material measurement in the test solutions during the exposure period are shown in Tables 1 -1 and 1 -2 (below):
Table 1-1 - Measured Concentrations of the Test Substance in Test Water during a 21 -day Exposure Period (Daphnia Reproduction Inhibition Test under Semi-Static Test Conditions)
Nominal Concentration (mg/L) |
Measured Concentration (mg/L) |
TWM *1(mg/L) |
% of Nominal |
||||||
Date |
0 |
1 |
7 |
8 |
14 |
15 |
|||
New |
Old |
New |
Old |
New |
Old |
||||
Control |
|
<0.007 |
<0.007 |
<0.007 |
<0.007 |
<0.007 |
<0.007 |
- |
- |
0.150 |
|
0.172 |
0.150 |
0.163 |
0.150 |
0.157 |
0.148 |
0.157 |
105 |
0.470 |
|
0.542 |
0.484 |
0.536 |
0.498 |
0.523 |
0.497 |
0.513 |
109 |
1.50 |
|
1.70 |
1.55 |
1.71 |
1.60 |
1.60 |
1.56 |
1.62 |
108 |
4.70 |
|
4.84 |
4.71 |
4.85 |
4.78 |
4.81 |
4.71 |
4.78 |
102 |
15.0 |
|
15.4 |
15.3 |
* |
* |
* |
* |
15.3 |
102 |
New |
Freshly prepared test solution |
||||||||
Old |
Old test solution before renewal |
||||||||
*1 |
Time-weighted mean measured concentration during 21 days |
||||||||
* |
No measurement was made because all parental Daphnia were dead |
Table 1 -2 - Measured Concentrations as a Percentage of Nominal
Nominal Concentration (mg/L) |
Measured Concentration as a Percentage of Nominal |
||||||
Date |
0 |
1 |
7 |
8 |
14 |
15 |
|
New |
Old |
New |
Old |
New |
Old |
||
0.150 |
|
115 |
100 |
109 |
100 |
105 |
99 |
0.470 |
|
115 |
103 |
114 |
106 |
111 |
106 |
1.50 |
|
113 |
103 |
114 |
107 |
107 |
104 |
4.70 |
|
103 |
100 |
103 |
102 |
102 |
100 |
15.0 |
|
103 |
102 |
* |
* |
* |
* |
New |
Freshly prepared test solution |
||||||
Old |
Old solution before renewal |
||||||
*1 |
Time-weighted mean measured concentration during 21 days |
||||||
* |
No measurement was made because all parental Daphnia were dead |
Cumulative mortality of parental Daphnia during the exposure period are shown in Tables 2 -1 and 2 -2 (below) and Figure 1 (attached):
Table 2 -1 - Cumulative Number of Dead Parental Daphnia
Days |
Nominal concentration |
|||||
Control |
0.150 mg/L |
0.470 mg/L |
1.50 mg/L |
4.70 mg/L |
15.0 mg/L |
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
1 |
1 |
3 |
0 |
0 |
0 |
0 |
1 |
5 |
4 |
0 |
0 |
0 |
0 |
1 |
9 |
5 |
0 |
0 |
0 |
0 |
2 |
10 |
6 |
0 |
0 |
0 |
0 |
2 |
10 |
7 |
0 |
0 |
0 |
0 |
2 |
10 |
8 |
0 |
0 |
0 |
0 |
2 |
10 |
9 |
0 |
0 |
0 |
0 |
2 |
10 |
10 |
0 |
0 |
0 |
0 |
2 |
10 |
11 |
0 |
0 |
0 |
0 |
2 |
10 |
12 |
0 |
0 |
0 |
0 |
2 |
10 |
13 |
0 |
0 |
0 |
0 |
2 |
10 |
14 |
0 |
1 |
0 |
0 |
2 |
10 |
15 |
0 |
1 |
0 |
0 |
2 |
10 |
16 |
0 |
1 |
0 |
0 |
2 |
10 |
17 |
0 |
1 |
0 |
0 |
2 |
10 |
18 |
0 |
1 |
0 |
0 |
2 |
10 |
19 |
0 |
1 |
0 |
0 |
2 |
10 |
20 |
0 |
1 |
0 |
0 |
2 |
10 |
21 |
0 |
1 |
0 |
0 |
2 |
10 |
Table 2 -2 - Mortality (%) of Parental Daphnia
Nominal concentration
|
Days |
|||||
1 |
2 |
4 |
7 |
14 |
21 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0.150 mg/L |
0 |
0 |
0 |
0 |
10 |
10 |
0.470 mg/L |
0 |
0 |
0 |
0 |
0 |
0 |
1.50 mg/L |
0 |
0 |
0 |
0 |
0 |
0 |
4.70 mg/L |
10 |
10 |
10 |
20 |
20 |
20 |
15.0 mg/L |
10 |
10 |
90 |
100 |
100 |
100 |
The days to the first brood production by parental Daphnia are shown in Table 3 (below) for each concentration:
Table 3 - Time (Days) to First Brood Production
Vessel Number |
Nominal Concentration mg/L |
|||||
Control |
0.150 |
0.470 |
1.50 |
4.70 |
15.0 |
|
1 |
8 |
8 |
8 |
8 |
8 |
* |
2 |
8 |
8 |
8 |
10 |
9 |
* |
3 |
8 |
8 |
8 |
8 |
9 |
* |
4 |
8 |
8 |
8 |
8 |
* |
* |
5 |
8 |
8 |
8 |
8 |
* |
* |
6 |
8 |
8 |
8 |
8 |
8 |
* |
7 |
8 |
8 |
8 |
8 |
8 |
* |
8 |
8 |
8 |
8 |
8 |
10 |
* |
9 |
8 |
8 |
8 |
8 |
8 |
* |
10 |
8 |
9 |
8 |
8 |
9 |
* |
Min |
8 |
8 |
8 |
8 |
8 |
* |
Max |
8 |
9 |
8 |
10 |
10 |
* |
* |
The parental Daphnia died before first brood production |
Mean cumulative numbers of juveniles produced per adult alive for the exposure period in each concentration are shown in Table 4 (below) and Figure 2 (attached):
Table 4 - Mean Cumulative Numbers of Juveniles Produced per Adult Alive for 21 Days (ΣFI/P)
Nominal Concentration |
Days |
|||||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
|
Control |
0.0 |
0.0 |
11.4 |
11.5 |
11.5 |
34.9 |
38.5 |
38.5 |
58.5 |
68.8 |
68.8 |
73.6 |
90.5 |
90.5 |
90.5 |
107.5
|
0.150 mg/L |
0.0 |
0.0 |
9.3 |
10.9 |
10.9 |
31.4 |
38.1 |
38.1 |
55.6 |
68.0 |
68.0 |
74.0 |
90.3 |
90.3 |
90.3 |
102.8 |
0.470 mg/L |
0.0 |
0.0 |
11.2 |
12.3 |
14.0 |
39.7 |
46.8 |
46.8 |
62.8 |
75.5 |
75.5 |
80.4 |
100.4 |
100.4 |
100.4 |
116.9 |
1.50 mg/L |
0.0 |
0.0 |
8.6 |
8.7 |
10.5 |
34.7 |
34.7 |
34.7 |
53.0 |
56.8 |
56.8 |
72.5 |
82.6 |
82.6 |
87.0 |
104.5 |
4.70 mg/L |
0.0 |
0.0 |
6.5 |
10.8 |
12.6 |
33.8 |
36.9 |
40.6 |
54.4 |
70.3 |
74.6 |
80.6 |
97.8 |
97.8 |
103.8 |
118.8 |
15.0 mg/L |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
* |
All parentalDaphniawere dead during the 21-day testing period |
The median lethal concentration (LC50) for parental Daphnia after the 21 -day exposure period is shown in Table 5 (below):
Table 5 - Calculated LC50 value for Parental Daphnia
Exposure Period (Days) |
LC50*1(mg/L) |
95% Confidence Limits (mg/L) |
Statistical Method |
21 |
6.77 |
1.50 – 15.0 |
Binomial |
*1 |
Based on the nominal concentration |
The 50% reproduction inhibition concentration (EC50) after 21 -day exposure is shown in Table 6 (below):
Table 6 - Calculated EC50 Values for Inhibition of Reproduction
Exposure Period (Days) |
EC50*1(mg/L) |
95% Confidence Limits (mg/L) |
Statistical Method |
21 |
8.40 |
-- |
Logit |
*1 |
Based on the nominal concentration |
||
-- |
Could not be determined |
The maximum No Observed Effect Concentration (NOEC) and the Lowest Observed Effect Concentration (LOEC) for cumulative number of juveniles produced per adult alive are shown in Table 7 (attached).
Temperature of the test solution, dissolved oxygen concentration, pH and hardness during the exposure period are shown in Tables 8, 9, 10 and 11 respectively (attached).
Description of key information
LC50 (21 d) 6.77 mg/L for Daphnia magna (OECD 211)
EC50 (21 d) 8.40 mg/L based on Daphnia magna reproduction (OECD 211)
LOEC (21 d) 15.0 mg/L for Daphnia magna (OECD 211)
NOEC (21 d) 4.70 mg/L for Daphnia magna (OECD 211)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 4.7 mg/L
Additional information
According to ECHA guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment, two long-term results (such as EC10 or NOECs) from species representing two trophic levels (fish and/or Daphnia and/or algae) permit an assessment factor of 50 to be applied when calculating the freshwater PNEC.
The availability of a GLP study with analytical monitoring, which describes long-term toxicity to Daphnia magna (Ministry of Environment, Japan, 2000), allows that report to be used in conjunction with the most reliable long-term toxicity data from algae (Ministry of Environment, Japan, 1996) during PNEC calculation.
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.