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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 217-968-7 | CAS number: 2022-85-7
- 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
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-05-27 - 2004-08-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Flucytosine
- EC Number:
- 217-968-7
- EC Name:
- Flucytosine
- Cas Number:
- 2022-85-7
- Molecular formula:
- C4H4FN3O
- IUPAC Name:
- flucytosine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Please refer to Test material information
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: Preliminary test samples were prepared, analysed initially and then after storage in sealed glass vessels at ambient temperature in light and dark conditions for approximately 24 hours (equivalent to the period of media renewal). The test material was stable in the test medium for the period of media renewal.
- Solubility and stability of the test substance in the solvent/vehicle: The concentration and stability of the test material in the test preparations were verified by chemical analysis at 0 hours (fresh media), 24 and 96 hours (old media). Analysis of the test preparations at 0, 24 and 96 hours (see Appendix 1) showed measured test concentrations to be near nominal.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: see below
- Final preparation of a solid: the test material was dissolved directly in dechlorinated tap water. An amount of test material (4000 mg) was dissolved in dechlorinated tap water with the aid of ultrasonication for approximately 5 minutes and the volume adjusted to 1 litre to give a 4000 mg/l stock solution. An aliquot (500 ml) of this 4000 mg/l stock solution was then added to a final
volume of 20 litres of dechlorinated tap water to give the 100 mg/l test concentration. This method of preparation was conducted in duplicate to give replicates R1 and R2 . The stock solution was inverted several times to ensure adequate mixing and homogeneity.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
see above
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Range finding test: 1.0, 10 and 100 mg/L; Definitive test: 100 mg/mL
-- Physico-chemical measurements: The water temperature, pH and dissolved oxygen concentrations were recorded daily throughout the test. The measurements at 0 hours, and after each test media renewal at 24, 48 and 72 hours, represent those of the freshly prepared test preparations while the measurements taken prior to each test media renewal, and on termination of the test after 96 hours, represent those of the used or 24-Hour old test preparations. The pH was measured using a WTW pH 320 pH meter, the dissolved oxygen concentration was measured using a YSI 550 dissolved oxygen meter and the temperature was measured using a Hanna Instruments HI 93510 digital thermometer.
-- Verification of test concentrations: Water samples were taken from the control and each replicate test vessel at 0 hours (fresh media), 24 and 96 hours (old media) for quantitative analysis. Duplicate samples and samples at 24 (fresh media), 48 and 72 hours (fresh and old media) were taken and stored at approximately -20°C for further analysis if necessary.
- Sample storage conditions before analysis: -20°C
Test solutions
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: For the purpose of the definitive test the test material was dissolved directly in dechlorinated tap water. An amount of test material (4000 mg) was dissolved in dechlorinated tap water with the aid of ultrasonication for approximately 5 minutes and the volume adjusted to 1 litre to give a 4000 mg/l stock solution. An aliquot (500 ml) of this 4000 mg/L stock solution was then added to a final
volume of 20 litres of dechlorinated tap water to give the 100 mg/L test concentration. This method of preparation was conducted in duplicate to give replicates R1 and R2 . The stock solution was inverted several times to ensure adequate mixing and homogeneity.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): A test sample was tested for stability without prior mixing (sonication) the test sample bottle to assess for losses due to adsorption and/or insolubility.The unsonicated stability vessel showed no evidence of insolubility or adherence to glass.
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: rainbow trout (Oncorhynchus mykiss)
- Source: Fish were obtained from Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Age at study initiation (mean and range, SD): juvenile
- Length at study initiation (length definition, mean, range and SD): mean standard length of 4.5 cm (sd = 0.3) at the end of the definitive test.
- Weight at study initiation (mean and range, SD): mean weight of 1.31 g (sd = 0.37) at the end of the definitive test.
- Method of breeding:
- Maintenance of the brood fish: in-house since 14 July 2004. Fish were maintained in a glass fibre tank with a "single pass" water renewal system.
ACCLIMATION
- Acclimation period: Fish were acclimatised to test conditions from 11 August 2004 to 23 August 2004.
- Acclimation conditions (same as test or not): The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.
- Type and amount of food during acclimation: The stock fish were fed commercial trout pellets which was discontinued 24 hours prior to the start of the definitive test.
- Health during acclimation (any mortality observed): There was zero mortality in the 7 days prior to the start of the test
FEEDING DURING TEST
none
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Remarks:
- Laboratory tap water, dechlorinated and softened
- Limit test:
- yes
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- approximately 100 mg/L as CaCO3
- Test temperature:
- approximately 14°C
- pH:
- mean pH = 7.6 prior to dechlorination and softening. There was no treatment related difference for pH.
- Dissolved oxygen:
- there was no treatment related difference for oxygen concentration
- Conductivity:
- mean 439 µS/cm prior to dechlorination and softening
- Nominal and measured concentrations:
- Analysis of the test preparations at 0, 24 and 96 hours (see Appendix 1) showed measured test concentrations to be near nominal.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: see below
- Type (delete if not applicable): The test vessels were covered to reduce evaporation
- Material, size, headspace, fill volume: 20 litre glass exposure vessels
- Aeration: The test vessels were aerated via narrow bore glass tubes.
- Renewal rate of test solution (frequency/flow rate):
A semi-static test regime was employed in the test involving a daily renewal of the test preparations to ensure that the concentrations of the test material remained near nominal and to prevent the build up of nitrogenous waste products.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The test water used for both the range-finding and definitive tests was the same as that used to maintain the stock fish.
Laboratory tap water was dechlorinated by passage through an activated carbon filter (Purite Series 500) and partly softened (Elga Nimbus 1248D Duplex Water Softener) giving water with a total hardness of approximately 100 mg/L as CaCO3. After dechlorination and softening the water was passed through a series of computer controlled plate heat exchangers to achieve the required temperature.
- Total organic carbon: 1.700 mg C/L prior to dechlorination and softening
- Pesticides: <0.010 µg/L prior to dechlorination and softening
- Chlorine: 27.000 mg Cl/L prior to dechlorination and softening
- Alkalinity: 113.000 mg HCO3/L prior to dechlorination and softening
- Ca/Mg ratio: 51.000 mg Ca/L; 8.000 mg Mg/L prior to dechlorination and softening
- Intervals of water quality measurement: The water temperature, pH and dissolved oxygen concentrations were recorded daily throughout the test. The measurements at 0 hours, and after each test media renewal at 24, 48 and 72 hours, represent those of the freshly prepared test preparations while the measurements taken prior to each test media renewal, and on termination of the test after 96 hours, represent those of the used or 24-Hour old test preparations.
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation.
TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Range finding study test concentrations: 1.0, 10 and 100 mg/L
- Definitive test test concentration: 100 mg/l
- Results used to determine the conditions for the definitive study: After 3, 6, 24, 48, 72 and 96 hours any mortalities or sub-lethal effects of exposure were determined by visual inspection of the test fish. There were no sub-lethal effects of exposure during the range-finding test. The results showed no mortalities at the test concentrations of 1.0, 10 and 100 mg/L.
Based on this information, a single test concentration, in duplicate, of 100 mg/L was selected for the definitive test.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: based upon mortalities and any sub- lethal effects
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: based upon mortalities and any sub- lethal effects
- Remarks on result:
- other:
- Remarks:
- nominal test conc. analytically verified
- Details on results:
- There were no sub-lethal effects of exposure observed in the test.
- Results with reference substance (positive control):
- -
- Reported statistics and error estimates:
- Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to be near nominal and so it was considered justifiable to estimate the LC 50 values in terms of the nominal test concentrations only.
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Range-finding Test
There were no sub-lethal effects of exposure during the range-finding test.
The results showed no mortalities at the test concentrations of 1.0, 10 and 100 mg/l.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of the test material to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LC 50 of greater than 100 mg/L. Correspondingly the No Observed Effect Concentration was 100 mg/L. No sub-lethal effects were observed.
Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to be near nominal and so the results are based on nominal test concentrations.
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.