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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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- repeated dose toxicity: other route
- Remarks:
- 21 days treatment
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- unsuitable test system
Data source
Reference
- Reference Type:
- publication
- Title:
- The Effect of Antifungal Agents on Pancreatic and Gastric Secretion in Rats
- Author:
- Yoon-Kee Park, Sungnack Lee, Won Joon Kim, and Sa Suk Hong
- Year:
- 1 979
- Bibliographic source:
- Archives of dermatological research 266.2 (1979): 103-108.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was undertaken to investigate the effect of 5-FC on pancreatic and gastric secretion in rats during long-term administration. For the experiment of pancreatico-biliary secretion 5-FC 100 mg/kg was given orally in a distilled water suspension i.p. for 3 weeks.
Measurement of Pancreatico-Biliary Enzymes
Mixed bile and pancreatic juice was collected for 2 h. Amylase, Lipase and the levels of cholate and bilirubin were determined.
Measurement of Gastric Secretion and Acidity
After 48 h a pyloric ligature was placed under light ether anesthesia. The animals were killed 5 h after pyloric ligation, and the gastric juice was collected. The volume was measured (mL/h/100 g body wt.) and pH of the juice was determined by Titrator TTT2b (Radiometer, Copenhagen). Free and total acid was determined by Titrator TTTzb connected to Autoburette ABO 11 (Radiometer). - GLP compliance:
- no
- Limit test:
- no
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:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: hybrid albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 180 g
- Fasting period before study: 24 h
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Details on exposure:
- 5-FC was given i.p. 100 mg/kg bw daily for 3 weeks
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- daily
Doses / concentrations
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- In 25 animals body weight changes were recorded, in 12 animals pancreaticobiliary secretion was measured, in 11 animals gastric secretion was measured
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: weekly, for 2 weeks
- Sacrifice and pathology:
- GROSS PATHOLOGY: No
HISTOPATHOLOGY: No - Other examinations:
- Measurement of Pancreatico-Biliary Enzymes
Amylase, Lipase and the levels of cholate and bilirubin from pancreatic juice were determined.
Measurement of Gastric Secretion and Acidity
The volume of gastric juice was measured (mL/h/100 g body wt.) and pH was determined by Titrator TTT2b (Radiometer, Copenhagen).
Results and discussion
Results of examinations
- Clinical signs:
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The growth rate of rats treated with 5-FC was markedly retarded. This seems to be caused by indigestion and loss of appetite after 5-FC intake.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- dose level: 100 mg/kg bw
- Effect level:
- > 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: There was a significant reduction in body weight gain during the first two weeks of treatment
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In the present study not conducted according to GLP or OECD guidelines male albino rats were administered 100 mg/kg bw, i.p. daily for 3 weeks. Subsequently, the pancreatic and gastric secretions were determined. The test substance revealed no effects on these parameters. However, the body weight was reduced, this effect was considered to be related to loss of appetite and indigestion. Since no mortalities or other adverse effects occurred a NOAEL value could not be established. Due to methodological deficiencies the study cannot be used for classification and labelling according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
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