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EC number: 603-973-5 | CAS number: 136673-12-6
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 48 h
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lithium 3[(8R,9S,10R,13S,14S,17S)-17-hydroxy-10-13-dimethyl-1,2,4,7,8,9,10,11,12,13,14,15,16,17-tetrahydrospiro[cylopenta[a]phenantrene-3,2´-[1,3]dioxolan]-17-yl]prop-2-ynoate
- EC Number:
- 603-973-5
- Cas Number:
- 136673-12-6
- Molecular formula:
- C24H31O5Li
- IUPAC Name:
- Lithium 3[(8R,9S,10R,13S,14S,17S)-17-hydroxy-10-13-dimethyl-1,2,4,7,8,9,10,11,12,13,14,15,16,17-tetrahydrospiro[cylopenta[a]phenantrene-3,2´-[1,3]dioxolan]-17-yl]prop-2-ynoate
- Test material form:
- solid: crystalline
1
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Details on test solutions:
- The test organism was bred and held in Elendt M4 medium which was also used for preparing of test item solutions. Young daphnids aged less than 24 hours at the start of the experiment were exposed to the test item for a period of 48 hours and acute toxic effect displayed as immobilization of test organism recorded at 24 and 48 hours after the start of test. The stock solution was prepared by measuring 100.11 mg of test item into 1 000 ml Elendt M4 growth medium. The suspension was ultrasonicated for 15 minutes. After it the suspension was filtered through a 0.2 μm WhatmanTM ME24 (Mixed cellulose ester) filter. The first 50 ml filtrate was disposed. The clear filtrate was the stock solution. The concentration of stock solution was 16.60 mg/L.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test species: Daphnia magna Straus
Age: < 24 hours neonates
Origin: National Institute of Environmental Health
Date of arriving: 16 May 2013
Culture conditions: The test species is maintained in Elendt M4 medium with culture conditions at 21±1 °C and a light/dark cycle of 16/8 hours with light intensities of less than 1000 Lux. The cultures are fed with centrifugalized green alga (Pseudokirchneriella subcapitata) cells daily at weekdays.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Nominal and measured concentrations:
- The toxic property of test item was investigated at six concentrations which were prepared by different dilutions of stock solution of test item. Elendt M4 medium was used for dilution of stock solution. In the test the following nominal concentrations were applied: 16.60; 11.62; 8.30; 6.64; 4.98 and 4.15 mg/L.
The concentration of test item was measured at each concentration level at start and at the end of the test by a validated HPLC method. The geometric means of measured concentrations were determined. The following actual concentrations were calculated from the measured values in the test: 16.33; 13.56; 9.55; 7.54; 5.50 and 4.53 mg test item/L. - Details on test conditions:
- Selection of young daphnids: On the first day of the test, all of juvenile daphnids were removed from the selected breeding cultures by sieving. Juvenile daphnids were disposed. Next day the neonates (which are younger than 24 hours) were separated from the parental culture by filtering and were transferred into test vessels.
Preparation of stock solution:
The preparation of stock and test solutions was based on the preliminary non GLP range finding test [9]. As the Range Finding Test was not performed in compliance with the GLP-Regulations it is excluded from the Statement of Compliance in the final report, but the raw data of this test are archived under the study code of present study. The stock solution was prepared by measuring 100.11 mg of test item into 1 000 ml Elendt M4 growth medium. The suspension was ultrasonicated for 15 minutes. After it the suspension was filtered through a 0.2 μm WhatmanTM ME24 (Mixed cellulose ester) filter. The first 50 ml filtrate was disposed. The clear filtrate was the stock solution. The concentration of stock solution was 16.60 mg/L.
Preparation of test solutions:
Seven dilution levels were prepared by mixing appropriate volume of Elendt M4 medium and stock solution of the test item. The maximum separation factor between of test vessels was 1.43.
Test procedure:
The test was maintained under static conditions for a period of 48 hours. At the start of the study each test vessels contained 50 ml of test solutions and five
young daphnids. In the test four replicates total of 20 animals at each test concentration level were investigated. The test vessels were covered with plastic lids and were kept in thermostat at 21 ± 1 °C with a 16/8 hours light/dark cycle. Each control vessels containing five young daphnids in Elendt M4 medium were
prepared in four replicates and kept under the same static conditions. The number of immobilised and abnormally behaved daphnids was recorded after 24
and 48h. A daphnia is considered to be immobile if it is not able to swim within 15 seconds after a gentle agitation of the test vessel. The daphnids were not fed during the test.
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The effective concentrations (ECx) were calculated with Probit analysis using linear max. Likelihood regression. The EC10, EC20 and EC50 were calculated for immobility at both 24 h and 48 h period. The No Observed Effect Concentration (NOEC) and Lowest Observed Effect Concentration (LOEC) of the test item were determined with Fisher’s exact binominal test with Bonferroni correction by ToxRat® software. The results were not conclusive
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Acute toxic effect of Prak-Li was investigated in Daphnia sp. Acute Immobilisation test (according to OECD 202 guideline). According to the test results Prak-Li has no toxic effect on mobility of Daphnia sp., even at its saturated concentration (16.33 mg/L). In this Daphnia sp., Acute Immobilisation Test for Prak-Li the results indicated that the test item is not hazardous to the aquatic environment [48 hr EC50 (for Crustacea) > saturated concentration of Prak-Li (16.33 mg/L)]
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