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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-08-03 to 2004-10-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- May 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- 1993
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
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
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8-12 weeks
- Weight at study initiation: 200 g - 350 g
- Fasting period before study: no
- Housing: in group of five animals by sex in solid-floor polypropyleene cages with stainless steel lids, furnished with softwood flakes (Datesand Ltd., Cheshire, UK) and cardboard "fun tunnels" (Datesand ltd., Cheshire, UK)
- Diet (e.g. ad libitum): ad libitum, except for exposure time (EU Rodent Diet 5LF2, BCM IPS Limited, London, UK)
- Water (e.g. ad libitum): ad libitum, except for exposure time
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- 5.5 µm
- Geometric standard deviation (GSD):
- 2.79
- Remark on MMAD/GSD:
- Inhalable fraction [% < 4 µm]: 37.7
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Exposure chamber (ADG Developments Ltd, Hitchin, Herts, UK)
- Exposure chamber volume: 30 L
- Method of holding animals in test chamber: individually, in a tapered, polycarbonate restraining tube fitted onto a tier of the exposure chamber and sealed by means of a rubber ‘O’ ring. Only the nose of each animal was exposed to the test atmosphere.
- System of generating particulates/aerosols: SAG 419 Solid Aerosol Generator
- Method of particle size determination: Samples were collected from the chamber, the samples and the back up filter were weighed before and after sampling and the weight of the sample was determined by calculating the difference. The mean amount for each stage was used to determine the cumulative amount below each cut-off point size. In this way, the proportion (%) of aerosol less than 9.3, 6.2, 3.2, 1.6, 1.00 and 0.33 µm was calculated. The resulting values were converted to probits and plotted against Log10 cut-point size.
- Treatment of exhaust air: extracts passed through a "scrubber" trap which is connected with a high efficiency filter to a metered exhaust system.
- Temperature, humidity, pressure in air chamber: 19°C, 31-65%, pressure not specified
TEST ATMOSPHERE
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: see table 1
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 5.50/2.79
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: The concentration used is the maximum attainable. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- The test atmosphere was sampled at approximately fifteen minute intervals during the exposure period and the actual concentration of the test material calculated.
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration: 20.4 mg/L
Mean analytical concentration: 5.17 mg/L - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on day of exposure and on day 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: incidence and severity of all abnormalities including behavioural and clinical observations, necropsy findings, bodyweight changes, mortality and any other toxicological effects. - Statistics:
- Probit analysis of particle size
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.17 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- not observed
- Clinical signs:
- other: hunched posture, piloerection, wet fur, increased respiratory rate were commonly seen in animals for short periods on removal from the chamber following 4h inhalation studies. These observations are considered to be associated with the restraint procedure
- Body weight:
- Variations in bodyweight gain are frequently seen for female animals of this strain and age during this type of study and, in isolation, are considered not to be significant.
One male showed reduced bodyweight gain during week 1 but recovered to show normal development during week 2. Normal development was noted for all other animals. - Gross pathology:
- Apart from one instance of dark patches on the lungs, no macroscopic abnormalities were detected amongst animals at necropsy.
Any other information on results incl. tables
Table 1: Particle size distribution
Impactor Stage number |
Cut point (µm) |
Mean Amount collected (mg) |
Mean cumulative Amount less than cut point [%] |
3 |
9.3 |
0.78 |
77.9 |
4 |
6.2 |
0.93 |
51.6 |
5 |
3.2 |
0.99 |
23.5 |
6 |
1.6 |
0.57 |
7.37 |
7 |
1.00 |
0.13 |
3.68 |
8 |
0.33 |
0.10 |
0.85 |
Backup filter |
< 0.33 |
0.03 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study conducted according to OECD guideline 403 (1981) 5 female and 5 male rats of the Crl:SD strain were exposed to 5.17 mg/L using a nose-only apparatus for 4h. There were no signs of toxicity and thus, 5-fluorocytosine does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with regard to acute inhalation toxicity.
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