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EC number: 268-608-0 | CAS number: 68131-04-4
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
Long-term toxicity to fish
Administrative data
- Endpoint:
- long-term toxicity to fish, other
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. Long-term toxicity test on invertebrates (Daphnia) was performed for source substance Humic acids potassium salts. The result of this test shows no toxicity based on long-term exposure. The results of short-term toxicity tests (fish, invertebrates, algae) for source substance show also no toxicity. Based on results of aquatic toxicity tests for Humic acids sodium salts no classification is required as well.
Based on all results the performing of long-term toxicity study on fish is scientifically not necessary. Moreover, this would mean unnecessary testing on vertebrates.
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 04.11.2019 - 18.12.2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable guideline study, tested with the source substance Humic acids, potassium salts. According to the ECHA guidance “Practical guide 6 the reliability was changed to RL2 to reflect the f act that this study was conducted on a read-across substance.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
See attached document in IUCLID Section 13 - Read across_fin
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See attached document in IUCLID Section 13 - Read across_fin
3. ANALOGUE APPROACH JUSTIFICATION
Using a technique Read across to predict endpoint information for Humic acids, sodium salts by using data from the same endpoint from source chemicals – Humic acids, potassium salts is appropriate based on similarities in general molecular structure of humic acids (the source of substances) as such and functionality of their water soluble salts. Production of sodium or potassium salts is only necessary for increase of bioavailability of humic acids. Given that both the source substance and the target substance is produced entirely in the same manner (source of oxyhumolite for both registered substances is the same and substances are manufactured exactly in the same manner) and
have comparable results in available studies, which did not lead to classification, it is expected that the results from long-term study on the target substance will not provide significantly different information. Therefore it is concluded as unnecessary to perform long-term toxicity study for Humic acids, sodium salts.
4. DATA MATRIX
See attached document in IUCLID Section 13 - Table 1: Data matrix - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- Adopted: October 2, 2012
- Deviations:
- yes
- Remarks:
- see Any other information
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Preliminary test: The analytical determination of the test item concentrations was performed once a week in the preparation of solutions (fresh solutions) and in the renewal of solutions (old solutions). The samples for analysis were taken from the highest (10 mg·L-1) and the lowest test concentration (1.0 mg·L-1). The samples for analysis (0 hours – fresh solution) were prepared once a week and immediately delivered in transport box to analytical laboratory. The samples for analysis in renewal (old solution) were taken in defined time intervals and delivered in transport box to analytical laboratory.
Definitive test: The analytical determination of the test item concentrations was performed once a week in the preparation of solutions (fresh solutions) and in the renewal of solutions (old solutions). The samples for analysis were taken from the concentrations 10 mg·L-1, 5 mg·L-1 and 1.2 mg·L-1. The samples for analysis (0 hours – fresh solution) were prepared once a week and immediately delivered in transport box to analytical laboratory. The samples for analysis in renewal (old solution) were taken in defined time intervals and delivered in transport box to analytical laboratory.
Sample storage conditions before analysis: all samples were stored at laboratory temperature. The samples were analyzed in the day of delivery. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The stock solution of the test item was prepared in M4 medium. 20 mg of the test item was weighed into 2000 mL of the M4 medium for the preliminary test and 50 mg of the test item was weighed into 1000 mL of the M4 medium for the definitive test. The fresh stock solutions were prepared three times per week.
The concentrations of solutions used in the preliminary and the definitive test were obtained by dilution of the stock solution with M4 medium.
Preliminary test: 10, 5, 1, 0 mg·L-1
Definitive test: 10, 5.9, 3.5, 2.1, 1.2, 0 mg·L-1 - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
Daphnia magna Straus
- Source, method: aperiodic parthenogenesis from own laboratory breeding
The grow-up gravid females are separated into M4 medium. Young daphnia born in 24 hours are segregated by observation under a microscope. Only the females are transferred to the test containers.
- Feeding during test, type, amount, frequency:
daily (out of 09.11., 10.11., 16.11., 17.11., 23.11., 24.11. in preliminary test and 30.11., 1.12., 07.12., 08.12., 14.12., 15.12. in the definitive test), the mixture of two algae (Desmodesmus subspicatus and Raphidocelis subcapitata 1:1), ration levels 0.5 mg C/daphnia/day at all times.
Volume of the mixture of algae for feeding: 430 µL/100 mL in preliminary test and 570 µL/100 mL in definitive test - Test type:
- semi-static
- Water media type:
- freshwater
- Remarks:
- The stock solutions of the M4 medium were prepared by adding measured amounts of the individual chemicals to deionized water.
- Limit test:
- no
- Total exposure duration:
- 21 d
- Post exposure observation period:
- none
- Hardness:
- Preliminary test: 2.44 – 2.51 mmol Ca+Mg /L
Definitive test: 2.43 – 2.49 mmol Ca+Mg /L - Test temperature:
- 20 ± 2°C, with a variation of ± 2°C at each individual test
- pH:
- Preliminary test: 8.1 – 8.5
Definitive test: 8.0 – 8.5 - Dissolved oxygen:
- Preliminary test: 7.5 – 8.5
Definitive test: 7.1 – 8.6 - Salinity:
- not applicable
- Conductivity:
- Preliminary test: 1.22 – 2.60 µS·cm-1
Definitive test: 1.54 – 1.98 µS·cm-1 - Nominal and measured concentrations:
- Preliminary test: 10, 5, 1 mg·L-1
Definitive test: 10, 5.9, 3.5, 2.1, 1.2, 0 mg·L-1 - Details on test conditions:
- TEST SYSTEM
- Material, size, headspace, fill volume: 100 ml
- Aeration: without
- Renewal rate of test solution (frequency/flow rate): 3× per week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Volume of the mixture of algae for feeding: 430 µL/100 mL in preliminary test and 570 µL/100 mL in definitive test
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionized water
- Test medium: M4
- Conductivity of the deionized water:
Preliminary test: 1.22 – 2.60 µS·cm-1
Definitive test: 1.54 – 1.98 µS·cm-1
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light
- Light intensity: 1568 – 1575 lx (not exceeding 1250 – 1670 lx in general) - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- The following data were recorded during the test: numbers of living offspring by each parent animal, presence of dead offspring and mortality parent animals. The total number of offspring per parent animal was calculated for each test vessel. If in any test vessel the parent animal died during the test, then the test vessel was excluded from the analysis.
The mean reproductive output for each concentration and control were calculated. Reduction of reproductive output was expressed in %.
- Mortality of control: 0 parent animal; 0 offspring
- Results with reference substance (positive control):
- a) Reference test
The sensitivity of the test species and correctness of test performance is periodically verified by testing with the reference substance, potassium dichromate. The results of the verification test with K2Cr2O7 are the following:
21 days – EC50 = 0.26 mg/L (95% confidence limit: 0.25 – 0.27 mg/L)
b) Data in the literature
HERMENS, JOOP, et al. Joint effects of a mixture of 14 chemicals on mortality and inhibition of reproduction of Daphnia magna. Aquatic Toxicology, Volume 5, Issue 4, November 1984, Pages 315-322.
21 days – EC50 = 0.27 mg/L
c) Method validity evaluation
The reduction in reproductive output of the test organism by the reference substance (21d – EC50) obtained from our reference test is conformable to the values stated in the literature (Hermens et al., 1984). - Reported statistics and error estimates:
- Analytical method (spectrophotometric method) - Data acquisitions and data processing were performed by using of the WinAspect Plus Version: 4.2.0.0. Statistical assessment of experimental data was carried out in Excel (Microsoft Corporation).
The value of EC50 and confidence intervals of the EC50 were calculated using the software ToxRat Professional Version 3.2.1. - Validity criteria fulfilled:
- yes
- Remarks:
- see Overall remarks
- Conclusions:
- The nominal concentrations of the test item were used for all evaluations and results.
21 days – EC50 = 3.2 mg/L (95% confidence limit: 1.9 – 5.2 mg·L-1)
21 days – EC10 = 0.3 mg/L (95% confidence limit: 0.2 - 0.4 mg·L-1)
Approach function: Non-linear Regression
21 days – NOEC < 1.2 mg·L-1, resp. 21 days – NOEC = 1.2 mg·L-1 for CSA - Executive summary:
The test item, Humic acids, potassium salts, was tested in reproduction test on Daphnia magna.
The test was performed according to OECD Test Guideline No. 211 - Daphnia magna Reproduction Test. Adopted: October 2, 2012.
The preliminary test was performed in a range of the test item concentrations 1 – 10 mg·L-1. The test was performed as semi-static, frequency of the test solutions renewal was three times a week.
The highest calculated reduction in reproductive output was 74.9 %. On the basis of the preliminary test results the definitive test was performed.
The definitive test was performed in a range of the test item concentrations 1.2 – 10 mg·L-1. The test was performed as semi-static, frequency of the test solutions renewal was three times a week.
The samples for analytical determination were taken once a week in the preparation of solutions (fresh solutions) and in the renewal of solutions (old solutions).
For all evaluations and results the nominal concentrations of the test item were used.
Test results, based on nominal concentration:
21 days – EC50 = 3.2 mg/L (95% confidence limit: 1.9 – 5.2 mg·L-1)
21 days – EC10 = 0.3 mg/L (95% confidence limit: 0.2 - 0.4 mg·L-1)
Approach function: Non-linear Regression
21 days – NOEC < 1.2 mg·L-1
The total number of living and dead daphnia
Concentration mg·L-1 |
Living offspring Total |
Living offspring of survived parents |
Dead parent animals |
Dead offspring Total |
10 |
156 |
156 |
0 |
0 |
5.9 |
224 |
224 |
0 |
0 |
3.5 |
305 |
305 |
0 |
0 |
2.1 |
350 |
350 |
0 |
0 |
1.2 |
411 |
411 |
0 |
0 |
K |
602 |
602 |
0 |
0 |
The evaluation of reduction in reproductive output of daphnia
Concentration mg·L-1 |
The mean number |
Reduction in reproductive output versus control % |
10 |
15.6 |
74.1 % |
5.9 |
22.4 |
62.8 % |
3.5 |
30.5 |
49.3 % |
2.1 |
35.0 |
41.9 % |
1.2 |
41.1 |
31.7 % |
K |
60.2 |
- |
Detailed information on offspring per individual replicate, concentration-response curve and results of chemical analyses are provided by file in section Attached bacround material.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
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