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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-329-1 | 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:
- 2016/05/19 - 2017/03/21
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- 100 mL of test samples from each replicates were drawn and mixed together for each group at 0 and 48 h. The samples were divided into two equal portions. One portion (200 mL) was sent for test concentration analysis and the second portion (200 mL) was stored at -20+-5°C temperature till the study completion.
- Vehicle:
- no
- Details on test solutions:
- An amount of 1000 mg DABQUEL COMPLEX ZnP was transferred in 100 mL volumetric flask and the volume was made up to the mark with reconstituted water to obtain the nominal concentration of 10.0 mg/mL (stock A). Volumes of 247.5, 370.0, 555.0, 832.5 and 1250.0 µL from the stock A were taken and diluted to 250 mL with reconstituted water in respective glass beakers of 600 mL capacity to obtain the nominal test concentrations of 9.9, 14.8, 22.2, 33.3 and 50.0 mg DABQUEL COMPLEX ZnP/L, respectively.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Source: Daphnids used for the study were cultured in the test facility. The master culture was procured from MicroBio Test Inc, Kleimoer 15, 9030 Mariakerke (Gent), Belgium.
- Age of parental stock: < 24h
- Feeding during test: no
ACCLIMATION
- Acclimation period: minimum of 48 h
- Acclimation conditions: same as test
- Type and amount of food:live algal cells (Pseudokirchneriella subcapitata)
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES
Freshly hatched daphnids were collected with the help of a micropipette and were used for the study. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 190.4 mg/L as CaCO3
- Test temperature:
- 20+-1°C
- pH:
- 7.63 - 7.93
- Dissolved oxygen:
- 8.40 - 8.91
- Nominal and measured concentrations:
- nominal 9.9, 14.8, 22.2, 33.3, 50 mg ZnP/L (measured active ingredient concentration was >80 % of nominal concentration)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass beaker (600 mL capacity)
- 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 diluent water was aerated, prior to use, so that dissolved oxygen concentration has reached saturation. Reconstituted water was prepared by adding different nutrients to the distilled water.
OTHER TEST CONDITIONS
- Photoperiod: 16:8 (light:dark cycle)
- light intensity: 1310 - 1330 lux
RANGE-FINDING STUDY
- Test concentrations: 0, 0.1, 1, 10, 50, 100 mg ZnP/L
- Results used to determine the conditions for the definitive study: percent immobilisation were 0,0,0,0,100 and 100% for the respective concentraions - Reference substance (positive control):
- yes
- Remarks:
- The test system was previously validated in the test facility using potassium dichromate as positive control.
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 9.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Remarks on result:
- other: measured active ingredient concentration was >80 % of nominal concentration
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 14.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Remarks on result:
- other: measured active ingredient concentration was >80 % of nominal concentration
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Remarks on result:
- other: measured active ingredient concentration was >80 % of nominal concentration
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 24.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Remarks on result:
- other: measured active ingredient concentration was >80 % of nominal concentration
- Details on results:
- The percent immobilisation observed at 24h were 0, 0, 0, 0 and 5 at the test concentrations of 9.9, 14.8, 22.2, 33.3 and 50 mg ZnP/L, respectively. No immobility was observed in any of the replicates of the control group.
The percent immobilisation observed at 48h were 0, 10, 50, 70 and 100 at the test concentrations of 9.9, 14.8, 22.2, 33.3 and 50 mg ZnP/L, respectively. No immobility was observed in any of the replicates of the control group.
At 24 h, No behavioural symptoms were observed in concentration 6 (50.0 mg/L). No immobility and behavioural symptoms were observed in concentration 5 (33.3 mg/L), concentration 4 (22.2 mg/L). Concentration 3 (14.8 mg/L), concentration 2 (9.9 mg/L) and control groups.
At 48 h, lethargy was observed in concentration 5 (33.3 mg/L), concentration 4 (22.2 mg/L), concentration 3 (14.8 mg/L). No immobility and behavioural symptoms were observed in concentration 2 (9.9 mg/L) and coontrol groups.
No signs of disease or stress, e.g., discoloration or unusual behaviour such as trapping at the surface of water were observed in any of the replicates of the control group - Results with reference substance (positive control):
- The percent immobilisation observed at 24h were 0, 0, 15, 40 and 55 at the test concentrations of 0.09, 0.2, 0.44, 0.96 and 2.11 mg potassium dichromate/L, respectively. No immobility was observed in any of the replicates of the control group.
The percent immobilisation observed at 48h were 0, 15, 40, 60 and 100 at the test concentrations of 0.09, 0.2, 0.44, 0.96 and 2.11 mg potassium dichromate/L, respectively. No immobility was observed in any of the replicates of the control group.
At 24 h, in concentration 6 (2.11 mg/L) and concentration 5 (0.96 mg/L) lethargy, floating at surface of water and at bottom of test vessel were observed. In concentration 3 (0.20 mg/L) floating at bottom of test vessel was observed. No behavioural symptoms were observed in concentration 4 (0.44 mg/L). No immobility and behavioural symptoms were observed in concentration 2 (0.09 mg/L) and control groups.
At 48 h, complete immobilisation was observed in all replicates of concentration 6 (2.11 mg/L). In concentration 5 (0.96 mg/L) and concentration 3 (0.20 mg/L) lethargy and floating at surface of water were observed. In concentration 4 (0.44 mg/L) lethargy and floating at bottom of test vessel were observed. No immobility and behavioural symptoms were observed in concentration 2 (0.09 mg/L) and control groups.
The highest tested concentration of potassium dichromate causing no immobilisation and the No Observed Effect Concentration (NOEC) was 0.09 mg/L and the lowest tested concentration causing 100% immobilisation within the 48 h test period was 2.11 mg/L.
The Lowest Observed Effect Concentration (LOEC) was 0.20 mg/L over the 48 h exposure period of potassium dichromate.
The 24 and 48 h EC50 of potassium dichromate were determined 1.63 and 0.67 mg/L, respectively. - Validity criteria fulfilled:
- yes
- Conclusions:
- Acute immobilisation study with D. magna (48 h) exposed to DABQUEL ZnP:
EC50 (48h): 24.9 mg ZnP/L
NOEC: 9.9 mg ZnP/L
LOEC: 14.8 mg ZnP/L - Executive summary:
A GLP-compliant key study on DABQUEL ZnP according to the OECD Guideline 202 (Acute Immobilisation of D. magna (48 h)) was performed. It had the following results:
EC50 (48h): 24.9 mg ZnP/L
NOEC: 9.9 mg ZnP/L
LOEC: 14.8 mg ZnP/L
Reference
Description of key information
Key study
A key study according to the OECD guideline 202 was performed to assess the toxic effects of the registered substance on Daphnia magna under static conditions.
Based on the results of the preliminary range finding study, the concentrations selected for the main study were 9.9, 14.8, 22.2, 33.3 and 50.0 mg/L. In the main study, a 48 h static toxicity test procedure was followed, comprising six groups. Each group consisted of four replicates with 5 daphnids per replicate.
The stability of the test item in test media was performed during method validation. The test item in test media was stable up to 48 h (>80% of nominal concentration). Test media was analysed for the active ingredient concentration and stability to monitor the concentration and stability of test solution at 0 and 48 h during main study. The active ingredient concentration of the registered substance in test media was within acceptable limit (>80% of nominal concentration).
The highest tested concentration of the registered substance causing no immobilisation and the No Observed Effect Concentration (NOEC) was 9.9 mg/L and the lowest tested concentration causing 100% immobilisation within the 48 h test period was 50.0 mg/L. The Lowest Observed Effect Concentration (LOEC) was 14.8 mg/L over the 48 h exposure period.
The EC50 (48 h) was determined to be 24.9 mg/L. As the test item has a zinc content of 14.2 %, the EC50 (48 h) for zinc is 3.536 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 24.9 mg/L
Additional information
Impact of environmental conditions on zinc toxicity
In the key study an EC50 (48 h) value of 24.9 mg ZnGHA/L was obtained for Daphnia magna (Kamle, 2017). When comparing to EC50 (48 h)-values for D. magna found in literature converted to the target substance ZnGHA, the value obtained in the key study exceeds the other values (table 1). There are several studies underlining the fact, that aquatic zinc toxicity significantly depends on environmental factors like pH-value (Schubauer-Berigan et al. 1993, Hyne et al. 2005), water hardness (Hyne et al. 2005,Barata et al. 1998) and dissolved organic carbon (DOC) content (De Schamphelaere et al. 2005).
pH-value
Decreasing pH was shown to decrease the zinc toxicity toD. magna(De Schamphelaere et al. 2005) andCeriodaphnia cf dubia(Hyne et al. 2005, Schubauer-Berigan et al. 1993), significantly.
Dissolved organic Carbon (DOC)
Zinc toxicity toCeriodaphnia cf dubiawas not affected significantly by increasing DOC concentration (Hyne et al., 2005). De Schamphelaere et al. (2005), in contrast, concluded that zinc toxicity is reduced by DOC, due to its complexing activity. However, there is a great variation between DOC referring their zinc-binding characteristics (De Schamphelaere et al., 2005).
Water hardness
There is a significant impact of water hardness on zinc toxicity, due to inorganic complexation. Ceriodaphnia cf dubiaexposed to zinc in U.S. EPA synthetic soft water (hardness 44 mg CaCO3/L) at a pH of 7.5, gave a 48-h EC50 value of 155 µg/L. When water hardness was increased (374 mg CaCO3/L) at the same pH of 7.5, zinc toxicity toC. cf dubiawas decreased significantly by two- to three-fold with a 48-h EC50 value of 390 µg/L (Hyne et al. 2005). Comparable results were found forD. magna(Barata et al. 1998, De Schamphelaere et al., 2005).
Genetic factors
The intra-species variability between differentD. magnaclones regarding sensitivity to zinc was studied. The different clones were exposed to single-metal solutions of varying concentration at two or three levels of water hardness (soft, moderate–hard and hard) for periods ranging from 12–96 h (12 h increments). There was a 2-fold difference in the EC50 values between the least sensitive and the most sensitive clone.
Conclusion
As a conclusion, several factors have been shown to influencing the zinc toxicity in field which are not accounted for in standardized toxicity tests.
Table 1: Effect concentration (EC)-values from studies performed with elemental zinc (Zn2+) converted to ZnGHA under consideration of the molecular weight and the purity
Species |
Duration of exposure |
Dose descriptor |
Basis for effect |
elemental Zn in source substance [mg/L] |
ZnGHA (75%) [mg/L] |
Impact |
Reference |
Daphnia magna |
48 h |
EC50 |
Immobilisation |
3.536 |
24.9 |
key study Kamle, 2017 |
|
D. magna |
48 h |
NOEC |
Immobilisation |
1.406 |
9.9 |
||
D. magna |
48 h |
LOEC |
Immobilisation |
2.102 |
14.8 |
||
D. magna |
48 h |
EC50 |
Immobilisation |
0.259 |
1.63 |
soft water 125 +- 6.2 mg/L CaCO3 clone C |
Barata et al. 1998 |
D. magna |
48 h |
EC50 |
Immobilisation |
0.131 |
0.83 |
soft water clone A |
|
D. magna |
48 h |
EC50 |
Immobilisation |
1.060 |
6.69 |
moderate-hard water (203 +- 8.2 mg/L CaCO3) clone C |
|
D. magna |
48 h |
EC50 |
Immobilisation |
0.457 |
2.88 |
moderate-hard water clone A |
|
D. magna |
48 h |
EC50 |
Immobilisation |
0.962 |
6.07 |
hard water (357 +- 12.5 mg/L CaCO3) clone C |
|
D. magna |
48 h |
EC50 |
Immobilisation |
0.601 |
3.79 |
hard water clone A |
|
D. magna |
48 h |
EC50 |
Immobilisation |
1.833 |
11.57 |
laboratory clone |
Muyssen et al. 2005 |
D. magna |
48 h |
EC50 |
Immobilisation |
2.650 |
16.73 |
natural clone acclimized to natural water with pH8.2 and 7.2 mg DOC/L |
|
D. magna |
48 h |
EC50 |
Immobilisation |
2.909 |
18.36 |
natural clone acclimized to natural water with 7.3 mg Zn/L, pH 8.3 and 8.2 mg DOC/L |
|
D. magna |
48 h |
EC50 |
Immobilisation |
3.29 |
20.77 |
pH 8, DOC 7.49 mg/L, Ca 52.7 |
De Schamphelaere et al. 2005 |
D. magna |
48 h |
EC50 |
Immobilisation |
0.354 |
2.23 |
pH 7.3, DOC 2.53 mg/L, Ca 5 mg/L |
|
Tetrahymena pyriformis |
1 h |
EC50 |
activity of nonspecific esterase |
0.2 |
1.26 |
Bogaerts et al. 1998 |
|
Ceriodaphnia sp. |
48 h |
EC50 |
Immobilisation |
0.382 |
2.41 |
pH 5.5 |
Hyne et al. 2005 |
Ceriodaphnia sp. |
48 h |
EC50 |
Immobilisation |
0.413 |
2.61 |
pH 6.5 |
|
Ceriodaphnia sp. |
48 h |
EC50 |
Immobilisation |
0.2 |
1.26 |
pH7.5 |
|
Ceriodaphnia sp. |
48 h |
EC50 |
Immobilisation |
0.155 |
0.98 |
hardness of 44 mg CaCO3/L at pH7.5 |
|
Ceriodaphnia sp. |
48 h |
EC50 |
Immobilisation |
0.39 |
2.46 |
hardness of 374 mg CaCO3/L at pH7.5 |
|
D. magna |
NOEC/EC10 |
reproduction |
0.1517 |
0.96 |
ARCHE 2011 |
||
Rhithrogena hageni |
96 h |
LC50 |
mortality |
50.5 |
318.75 |
Brinkman and Johnston 2008 |
|
C. dubia |
48 h |
LC50 |
mortality |
>0.53 |
>3.35 |
pH 6-6.5 |
Schubauer-Berigan et al. 1993 |
C. dubia |
48 h |
LC50 |
mortality |
0.36 |
2.27 |
pH 7-7.5 |
|
C. dubia |
48 h |
LC50 |
mortality |
0.95 |
0.6 |
pH 8-8.5 |
|
C. dubia |
48 h |
EC50 |
mortality |
0.67 |
4.23 |
acclimation to 3 µg Zn/L for 10 generations |
Muyssen and Janssen 2002 |
C. dubia |
48 h |
EC50 |
mortality |
0.8 |
5.05 |
acclimation to 13 µg Zn/L for 10 generations |
|
C. dubia |
48 h |
EC50 |
mortality |
0.507 |
3.2 |
acclimation to 50 µg Zn/L for 10 generations |
|
C. dubia |
48 h |
EC50 |
mortality |
0.507 |
3.2 |
acclimation to 100 µg Zn/L for 10 generations |
|
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.