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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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- 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 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- 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, 328 and 1050 mg/L
- Sampling method: All the solutions will be analysed taken directly from the starting solutions without fish.
If the analyses are not carried out on time, the solutions are kept in refrigerator or freeze. It is notified in the final report. - Vehicle:
- no
- Details on test solutions:
- According to the sponsor, the test item is soluble in water. The dilution water was the fish test medium, a weakly saline aqueous medium.
The solutions were prepared by adding directly the test item in fish test medium - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Strain: not specified
- Source: Elevage de la Grande Rivière, La Fond Garel, 69490 ST FORGEUX (Approval number : A69-200-1301). Batch Number: 150317
- Age at study initiation (mean and range, SD): not specified
- Length at study initiation (length definition, mean, range and SD): 25 to 30 mm
- Weight at study initiation (mean and range, SD): not specified
ACCLIMATION
- Acclimation period:
Every batch of fish received in the laboratory were held in the dilution water for a minimum time period of 12 days before testing.
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: not specified
- Feeding frequency during acclimation: not specified
- Health during acclimation (any mortality observed): free from any apparent malformations and diseases.
FEEDING DURING TEST
no - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Test temperature:
- 22.8-23.4°C
- pH:
- 6.6-7.9
- Dissolved oxygen:
- 90-98%
- Nominal and measured concentrations:
- nominal: 0, 10, 32, 102, 328, 1050
measured: see table below - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquarium
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 15cm * 15cm * 20 cm containing 2.5L of the test solution
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 8
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: 1.0 g/L
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light / 8 hours darkness
- Light intensity: not specified
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality
TEST CONCENTRATIONS
0, 10, 32, 102, 328, 1050
- Range finding stud: yes
- Test concentrations:
range finding study: 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
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 050 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Results with reference substance (positive control):
- The toxic response obtained on the reference item K2Cr2O7 for the Fish batch number 150317 gives a LC50-24h of 190.6 mg/L [169.9 – 213.7], in accordance with historical data obtained by our laboratory.
- Reported statistics and error estimates:
- See table below.
- Sublethal observations / clinical signs:
The statistical treatment of the data permitted to giveLC50values at different observation times.
LC50values at different observation times (Value expressed in nominal test item concentration) are presented hereafter.
Observation time
24h
48h
72h
96h
LC50in mg/L
>1050 mg/L
>1050 mg/L
>1050 mg/L
>1050 mg/L
Validity criteria conformity
Criteria
Validity for OECD 203
Validity for the test
Control mortality
≤ 1 fish
Ok (0)
Conditions
Constant
Ok (22.8 to 23.4 °C)
Dissolved oxygen concentration
> 60%
Ok (90%)
Concentrations maintaining
± 20%
YES (2.3 to 6.3%)
NA: Not applicable (see § 11.4.5)
All the validity criteria were successful.
- 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 “mortality” give an LC50-96h higher than 1050 mg/L (highest tested concentration), values expressed in nominal test item concentration. - Executive summary:
This study was carried out in accordance with the study plan no.17/1107F/d dated October 23, 2017.
There was no deviation and no amendment 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 fishDanio rerio, according to the OECD 203 guideline, in static conditions.
According to the sponsor, chemical analyses of the test item in the test solutions were performed during the test.
Validity criteria conformity:
Criteria
Validity for OECD 203
Validity for the test
Control mortality
≤ 1 fish
Ok (0)
Conditions
Constant
Ok (22.8 to 23.4 °C)
Dissolved oxygen concentration
> 60%
Ok (90%)
Concentrations maintaining
± 20%
YES (2.3 to 6.3%)
All the validity criteria were successful.
Fish lethality
Nominal test item concentrations
(mg/L)Number of fish exposed at the start
Cumulative number of dead fish
at each observation time (%)24h
48h
72h
96h
Control
8
0 (0%)
0 (0%)
0 (0%)
0 (0%)
10
8
0 (0%)
0 (0%)
0 (0%)
0 (0%)
32
8
0 (0%)
0 (0%)
0 (0%)
0 (0%)
102
8
0 (0%)
0 (0%)
0 (0%)
0 (0%)
328
8
0 (0%)
0 (0%)
0 (0%)
0 (0%)
1050
8
0 (0%)
0 (0%)
0 (0%)
0 (0%)
LC50values at different observation times(Value expressed in nominal test item concentration) are presented hereafter.
Observation time
24h
48h
72h
96h
LC50in mg/L
> 1050 mg/L
> 1050 mg/L
> 1050 mg/L
> 1050 mg/L
The results obtained for the test item « REACTION MIXTURE OF ZnEDTA, ZnDTPA AND ZnHEEDTA» on the toxicological endpoint “mortality” give an LC50-96h higher than 1050 mg/L(highest tested concentration), values expressed in nominal test item concentration.
Reference
Description of key information
Information on the short-term toxicity to fish is available for one category member. 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 the chelating agents.
The 96h LC50 for fish (OECD 203) was determined to exceed 1050 mg/L for the metal chelate with zinc.
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 fish.
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.
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