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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
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:
- from 2018-10-15 to 2019-04-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The Guidelines for the Testing of Chemicals, Effects on Biotic Systems, 211 "Daphnia magna Reproduction Test", China Environment Press
- Version / remarks:
- second edition, 2013.8
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The concentrations of test item were determined at 0, 2, 7, 9, 14, 16 d in fresh media and 2, 5, 9, 12, 16, 19 d in old media, in the control and test concentrations. 20 mL solution were sampled directly and filtered with 0.45 μm membrane to sample vial and the rest was stored in refrigerator (2 - 8 °C) for possible re-analysis and until the end of the test.
- Vehicle:
- no
- Details on test solutions:
- 0.02000 ~ 0.02002 g of the test item were weighed out and directly dissolved in 2 L test water (tap water treated with Aquapro Pure Warer System). Afterwards, the test item was thoroughly dissolved by stirring to get the solution of nominal concentration of 10 mg/L. The solution was used for exposure and as stock solution to prepare lower test concentrations. About 100 mL of each solution were dispensed into each test vessel for each concentration.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia of stock culture were originally obtained from Applying Chemistry Department Pesticide Environmental Evaluation Laboratory of China Agricultural University. The test Daphnia were derived from a same healthy pre-cultured population (i.e. showing no signs of stress such as high mortality, presence of males and ephippia, delay in the production of the first brood, discoloured animals, etc.). The pre-cultured animals were maintained under culture conditions (light, temperature, and medium) similar to those that were in the test. The test animals were less than 24 hours old and not the first brood progeny.
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 180 mg CaCO3 /L (dilution water)
- Test temperature:
- 18.3 - 21.6°C
- pH:
- 7.7 - 8.2
- Dissolved oxygen:
- 8.6 - 9.6 mg/L
- Salinity:
- N/A
- Nominal and measured concentrations:
- Nominal: 0.625, 1.25, 2.5, 5, 10 mg/L
Measured (geometric mean): 0.637, 1.323, 3.011, 6.020, 10.747 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Type: loosely covered
- Material, size, headspace, fill volume: glass, 250 mL total volume, 100 mL fill volume
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): three times a week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water
- Total organic carbon: < 2 mg/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: every three months
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light : 8 h dark
- Light intensity: 1000 - 1500 lux cool white light
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, reproductive output per surviving parent animal, length of living parent animals, total number of broods per parent, first brood time
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10 mg/L (21 d)
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- K2Cr2O7
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.195 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.195 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 11.016 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality
- Remarks:
- parental animals
- Details on results:
- - Behavioural abnormalities:
None
- Observations on body length and weight: NOEC (length of parent) = 11.016 mg/L
- Other biological observations: None
- Mortality of control: None - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: 24-h EC50 = 1.34 mg/L corresponding to a normal sensitivity - Reported statistics and error estimates:
- N/A
- Validity criteria fulfilled:
- yes
- Conclusions:
- The substance showed a 21-d NOEC (reproduction) of 1.195 mg/L to Daphnia magna in an OECD 211 guideline study. The substance concentration were analytically verified. The substance is not considered to be chronically toxic to aquatic invertebrates.
- Executive summary:
A Daphnia magna Reproduction Test was conducted with Daphnia magna over a 21 days exposure period.
Based on the results of the preliminary test, the definitive test was carried out at concentrations of 0.625, 1.25, 2.5, 5 and 10 mg/L (nominal concentration). A concurrent blank control was performed in parallel. 10 daphnids individually held were used for each test group and the control group. The actual concentrations of test solutions were measured with an HPLC method.
Based on the results of the preliminary test, a semi-static system with solution renewed at three times a week, on every Monday, Wednesday and Friday was used in the definitive test.Oxygen concentration and pH values weremeasured twice a week, in fresh and old media,duringthe 21 days exposure periodin the control and in the testitemconcentration.Total hardnesswasmeasured in the controlonce a week.Temperature was continuously monitored and recorded by an automatic temperature monitoring system.
The concentrations ofthe test itemwere determined in samples of the test media by HPLC method. The results showed thatfor the test solutions of 0.625, 1.25, 2.5, 5 and 10 mg/L,the geometric mean determined concentrations in fresh media were 0.637, 1.323, 3.011, 6.020 and 10.747 mg/L. The geometric mean determined concentrations in old media were 0.250, 1.080, 2.429, 5.289 and 11.291 mg/L. The overall geometric mean determined concentrations were 0.399, 1.195, 2.551, 5.325 and 11.016 mg/L corresponding to 63.8% for 0.625 mg/L and 95%-110% of the nominal values for other concentrations.
Total number ofliving offspring per parent, body length of parent, maternal mortality, first brood time and total number of broods per parent wereanalyzed by a two-sided Student´s T-test using a 5% significancelevel to obtain the no observed effect concentration (NOEC) and the lowest observed effect concentration (LOEC).
The 21-day NOEC and LOEC for all the parameters based on the measured concentration were as below:
Parameter
NOEC
(Measured concentration)
LOEC
(Measured concentration)
Total number ofliving offspring per parent
1.195 mg/L
2.551 mg/L
Body length of parent
11.016 mg/L
> 11.016 mg/L
Mortality parent
11.016 mg/L
> 11.016 mg/L
First brood time
11.016 mg/L
> 11.016 mg/L
Total number of broods per parent
1.195 mg/L
2.551 mg/L
The EC10 of test item to total living offspring per parent was calculated by using EPA PROBIT ANALYSIS PROGRAM USED FOR CALCULATION LC/EC VALUES (Version 1.5). The EC10 of test item to total living offspring per parent was 1.187 mg/L, with 95% confidence limit of 0.767-1.591 mg/L based on measured concentration.
Reference
Description of key information
The substance showed a 21-d NOEC (reproduction) of 1.195 mg/L to Daphnia magna in an OECD 211 guideline study. The substance concentration were analytically verified. The substance is not considered to be chronically toxic to aquatic invertebrates.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 1.195 mg/L
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.