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EC number: 902-532-7 | 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See the documentation in support for the category approach.
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See the documentation in support for the category approach. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- Non critical deviation
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: the control, the lowest, the highest concentrations and a concentration around the expected EC50 concentration: 0, 2, 20.7 and 100 mg/L
- Sampling method: All the solutions will be analysed taken directly from the starting solutions without daphnids.
- Sample storage conditions before analysis: All the solutions were kept in refrigerator or freeze in order to be analyzed if necessary or relevant. - Vehicle:
- no
- Details on test solutions:
- According to the sponsor, the test item is soluble in water. The dilution water was the daphnids test medium, a weakly saline aqueous medium.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name:
- Strain/clone: clone number 5
- Justification for species other than prescribed by test guideline: not relevant
- Source: laboratory culture
- Age of parental stock (mean and range, SD): not specified
- Feeding during test: no
- Food type: not specified
- Amount: not specified
- Frequency: not specified
ACCLIMATION
no acclimation
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Test temperature:
- 19.8 – 20.0°C
- pH:
- 7.6-7.9
- Dissolved oxygen:
- 8.9-9.3 mg/L
- Nominal and measured concentrations:
- Nominal concentration (mg/L): 2.0, 4.3, 9.4, 20.7, 45.5, 100.0.
Measured concentrations: see table below - Details on test conditions:
- TEST SYSTEM
- Test vessel: tube
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass tubes of 10 ml
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not relevant
- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): not relevant
- Biomass loading rate: not specified
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ultrapure water
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Adjustment of pH: not needed
- Photoperiod: total darkness
- Light intensity: not relevant
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilization (24 and 48 hours)
VEHICLE CONTROL PERFORMED: no
RANGE-FINDING STUDY
- Test concentrations: 0, 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 64.74 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 18.05 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- No sign of stress was observed on the mobile daphnids after 48 hours of exposure to the highest concentration.
- Results with reference substance (positive control):
- The last toxic response obtained on the reference item K2Cr2O7 (November 2, 2017) gives an EC50-24h of 1.38 mg/L (1.26 – 1.51), indicating that the daphnids sensitivity is correct (within the accepted interval of 0.6 – 2.1 mg/L fixed by the International Standard ISO 6341 December 2012 as mentioned in the OECD 202 Guideline) and in accordance with historical data obtained by the laboratory.
- Reported statistics and error estimates:
- See table.
- Validity criteria fulfilled:
- yes
- Conclusions:
- All the validity criteria were successful.
The results obtained for the test item “REACTION MIXTURE OF CuDTPA and CuHEEDTA” on the toxicological endpoint “immobilisation” give an EC50-24h = 64.74 mg/L [53.84 – 78.15] and an EC50-48h = 18.05 mg/L [14.53 22.66] based on nominal test item concentrations. - Executive summary:
This study was carried out in accordance with the study plan no.17/1108F/d dated November 6, 2017.
There was one deviation (cf. 9.3) to the study plan during this study.
There was no amendment during this study.
The aim of this study was to assess the effects of the test item “REACTION MIXTURE OF CuDTPA and CuHEEDTA”on the daphnidsDaphnia magna, according to the OECD 202 guideline, in static conditions.
The concentrations which immobilise 50% of the daphnids exposed to the test item after 24 and 48 hours, reported as EC50-24h and EC50-48h were evaluated, relative to the tested concentrations.
According to the sponsor, chemical analyses of “REACTION MIXTURE OF CuDTPA and CuHEEDTA” in the test solutions was performed by ICP/OES in order to check the test item stability throughout the study.
The test item « REACTION MIXTURE OF CuDTPA and CuHEEDTA» was considered stable under test conditions because the measured concentrationsof Copper (Cu) in samples containing the test itemdid not vary more than ± 20 % during the test.
The values are based on nominal test item “REACTION MIXTURE OF CuDTPA and CuHEEDTA” concentration.
Validity criteria conformity:
Values for OECD 202
Validity criteria for the test
Immobilised daphnids in control
<10%
Yes (0%)
Dissolved Oxygen concentration
>3 mg/L
Yes (8.9 mg/L)
All the validity criteria were successful.
Daphnids immobilisation
Nominal test item concentrations in mg/L
Number of daphnids exposed at the start
Immobilised daphnids (%)
at 24h
at 48h
Control
20
0 (0%)
0 (0%)
2.0
20
0 (0%)
0 (0%)
4.3
20
0 (0%)
0 (0%)
9.4
20
0 (0%)
3 (15%)
20.7
20
0 (0%)
10 (50%)
45.5
20
3 (15%)
20 (100%)
100.0
20
18 (90%)
20 (100%)
EC50values at different observation times
Observation time
24h
48h
EC50in mg/l
[Confidence interval]
64.74 mg/L
[53.84 – 78.15]
18.05 mg/L
[14.53 – 22.66]
The results obtained for the test item “REACTION MIXTURE OF CuDTPA and CuHEEDTA” on the toxicological endpoint “immobilisation” give an EC50-24h = 64.74 mg/L [53.84 – 78.15] and an EC50-48h = 18.05 mg/L [14.53 - 22.66]based on nominal test item concentrations.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See the documentation in support for the category approach.
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See the documentation in support for the category approach. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- Non critical deviation
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: the control, the lowest, the highest concentrations and a concentration around the expected EC50 concentration: 0, 10, 231 and 1118 mg/L
- Sampling method: All the solutions will be analysed taken directly from the starting solutions without daphnids.
- Sample storage conditions before analysis: All the solutions were kept in refrigerator or freeze in order to be analyzed if necessary or relevant. - Vehicle:
- no
- Details on test solutions:
- According to the sponsor, the test item is soluble in water. The dilution water was the daphnids test medium, a weakly saline aqueous medium.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name:
- Strain/clone: clone number 5
- Justification for species other than prescribed by test guideline: not relevant
- Source: laboratory culture
- Age of parental stock (mean and range, SD): not specified
- Feeding during test: no
- Food type: not specified
- Amount: not specified
- Frequency: not specified
ACCLIMATION
no acclimation
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Test temperature:
- 19.8 – 20.0°C
- pH:
- 6.5-7.9
- Dissolved oxygen:
- 8.8-9.1 mg/L
- Nominal and measured concentrations:
- Nominal concentration (mg/L): 0, 10, 20, 48, 105, 231, 508, 1118
Measured concentrations: see table below - Details on test conditions:
- TEST SYSTEM
- Test vessel: tube
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass tubes of 10 ml
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not relevant
- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): not relevant
- Biomass loading rate: not specified
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ultrapure water
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Adjustment of pH: not needed
- Photoperiod: total darkness
- Light intensity: not relevant
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilization (24 and 48 hours)
VEHICLE CONTROL PERFORMED: no
RANGE-FINDING STUDY
- Test concentrations: 0, 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 118 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 118 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- No sign of stress was observed on the mobile daphnids after 48 hours of exposure to the highest concentration.
- Results with reference substance (positive control):
- The last toxic response obtained on the reference item K2Cr2O7 (November 2, 2017) gives an EC50-24h of 1.38 mg/L (1.26 – 1.51), indicating that the daphnids sensitivity is correct (within the accepted interval of 0.6 – 2.1 mg/L fixed by the International Standard ISO 6341 December 2012 as mentioned in the OECD 202 Guideline) and in accordance with historical data obtained by the laboratory.
- Reported statistics and error estimates:
- See table.
- Validity criteria fulfilled:
- yes
- Conclusions:
- All the validity criteria were successful.
The results obtained for the test item “REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA ” on the toxicological endpoint “immobilisation” give an EC50-24h and an EC50-48h higher than 1118 mg/l (highest tested concentration) based on nominal test item concentrations. - Executive summary:
This study was carried out in accordance with the study plan no.17/1107F/f dated October 24, 2017.
There was no deviation and no amendment to the study plan during this study.
The aim of this study was to assess the effects of the test item “REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA” on the daphnids Daphnia magna, according to the OECD 202 guideline, in static conditions.
The concentrations which immobilise 50% of the daphnids exposed to the test item after 24 and 48 hours, reported as EC50-24h and EC50-48h were evaluated, relative to the tested concentrations.
According to the sponsor, chemical analyses of “REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA” in the test solutions was performed by ICP/OES in order to check the test item stability throughout the study.
The test item « REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA» was considered stable under test conditions because the measured concentrationsof Zinc (Zn) in samples containing the test itemdid not vary more than ± 20 % during the test.
The values are based on nominal test item “REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA”concentration.
Validity criteria conformity:
Values for OECD 202
Validity criteria for the test
Immobilised daphnids in control
<10%
Yes (0%)
Dissolved Oxygen concentration
>3 mg/L
Yes (8.9 mg/L)
All the validity criteria were successful.
Daphnids immobilisation
Nominal test item concentrations in mg/L
Number of daphnids exposed at the start
Immobilised daphnids (%)
at 24h
at 48h
Control
20
0 (0%)
0 (0%)
10
20
0 (0%)
0 (0%)
22
20
0 (0%)
0 (0%)
48
20
0 (0%)
0 (0%)
105
20
0 (0%)
0 (0%)
231
20
0 (0%)
0 (0%)
508
20
0 (0%)
0 (0%)
1118
20
0 (0%)
0 (0%)
EC50values at different observation times
Observation time
24h
48h
EC50in mg/l
>1118 mg/L
>1118 mg/L
The results obtained for the test item “REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA” on the toxicological endpoint “immobilisation” give an EC50-24h and an EC50-48h higher than 1118 mg/L (highest tested concentration) based on nominal test item concentrations.
Referenceopen allclose all
Validity criteria for the test
|
Criteria for OECD 202 |
Validity criteria conformity |
Immobilised daphnids in the Control |
<10% |
Yes (0%) |
Dissolved Oxygen at the end of the test |
>3 mg/L |
Yes (8.9 mg/L) |
EC50 values for immobilization
Observation time |
24h |
48h |
EC50in mg/l [Confidence interval] |
64.74 mg/L [53.84 – 78.15] |
18.05 mg/L [14.53 – 22.66] |
Validity criteria for the test
|
Criteria for OECD 202 |
Validity criteria conformity |
Immobilised daphnids in the Control |
<10% |
Yes (0%) |
Dissolved Oxygen at the end of the test |
>3 mg/L |
Yes (8.9 mg/L) |
All the validity criteria were successful.
EC50 values for immobilization
Observation time |
24h |
48h |
EC50in mg/l |
>1118 mg/L |
>1118 mg/L |
Description of key information
Information on the short-term toxicity to aquatic invertebrates is available for two category members: metal chelates with copper and zinc. The result is in line with the expectations i.e. that the aquatic toxicity is the result of the free (metal) ion that is complexed and that this ion is much less bioavailable and thus less toxic to aquatic life when complexed with chelating agents. As expected, the order of aquatic toxicity of the metal chelates follows the order of toxicity of the metal ions: copper chelate is more toxic than zinc chelate. Therefore, it is reasonable to assume that the aquatic toxicity of KCa2DTPA will be lower than that of zinc chelate.
The EC50 for Daphnia magna (OECD 202) was determined to exceed 1118 mg/L for the zinc chelate.
Considering that the aquatic toxicity is determined by the metal ion and that K and Ca are orders of magnitude less toxic than Zn, the substance is not considered toxic to aquatic invertebrates.
Key value for chemical safety assessment
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.
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.