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EC number: 265-025-3 | CAS number: 64704-23-0
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study from supporting substance (structural analogue)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- - Principle of test:
The test materials cystenosine, inosine, an cystine were administered orally, and symptom and weight changes were observed.
- Short description of test conditions: Experiment was carried out on 4-week-old male and female rats fasted for 16 hours before drug administration via feeding tube. The animals still alive after seven days post-drug were sacrificed and autopsy was performed.
- Parameters analysed / observed: Symptom and weight changes were observed for seven days after drug administration. - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cystine
- EC Number:
- 200-296-3
- EC Name:
- Cystine
- Cas Number:
- 56-89-3
- Molecular formula:
- C6H12N2O4S2
- IUPAC Name:
- cystine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test materials Cystenosine, Inosine, and Cystine were suspended in 5% gum arabic aqueous solutions
- Cystenosine is a blend of Inosine and Cystine at a weight ratio of 10:1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- JCL
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan CREA
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: 4 weeks
- Weight at study initiation: not reported
- Fasting period before study: 16 hours
- Housing: males and females housed separately; dose groups housed separately
- Diet (e.g. ad libitum): CA-1 pellets (Japan CREA) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 5%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: gum arabic aqueous solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5% gum arabic aqueous solution
- Amount of vehicle (if gavage): 5 mL/100 g body weight
- Justification for choice of vehicle: not specified
- Lot/batch no. (if required): not reported
- Purity: not reported
MAXIMUM DOSE VOLUME APPLIED: 25,000 mg/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 25,000 mg/kg body weight was the maximum allowable administration quantity. - Doses:
- 10,000 and 25,000 mg/kg of body weight
- No. of animals per sex per dose:
- 10 males, 10 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: at least once a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- none
Results and discussion
- Preliminary study:
- none
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Remarks:
- Cystenosine, Inosine, and Cystine (separately)
- Effect level:
- >= 25 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- One (female) rat died after 28 hours in the 25,000 mg/kg Cystine group
- Clinical signs:
- Drop in body temperature, dirtying around the lower abdomen, and a decrease in spontaneous exercise seen in 2 or 3 females 24-48 hours after administration of 25,000 mg/kg Cystine. One rat died, but remaining rats returned to normal by 72 hours.
- Body weight:
- In the 25,000 mg/kg Cystine group, suppression of weight increase was found 1 to 2 days after administration in males and females, but a progressive increase in body weight was subsequently exhibited.
- Gross pathology:
- In the 25,000 mg/kg Cystine group, the results of autopsy showed punctate bleeding on the stomach fundus and hematuria in the bladder, but there were no particularly abnormal findings in the living specimens.
Any other information on results incl. tables
Table 1. The acute toxicity of Cystenosine, Inosine, and Cystine
Compound | Doses (mg/kg) | Dead / Total Treated | |
Male | Female | ||
Cystenosine | 10000 | 0/10 | 0/10 |
25000 | 0/10 | 0/10 | |
Inosine | 10000 | 0/10 | 0/10 |
25000 | 0/10 | 0/10 | |
Cystine | 10000 | 0/10 | 0/10 |
25000 | 0/10 | 1/10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No particular abnormalities or all-encompassing adverse effects were seen in this 7-day acute toxicity test of Cystenosine, Inosine, and Cystine (administered separately). One female rat died during the observation period. The LD50 of each of three substances is at least 25,000 mg/kg body weight.
- Executive summary:
Cystenosine, inosine and cystine were suspended in 5% gum arabic aqueous solutions and administered separately by oral gavage to four-week old Wistar JCL male and female rats at doses of 10,000 mg/kg or 25,000 mg/kg bw. No particular abnormalities or all-encompassing adverse effects were seen in this 7-day acute toxicity test of Cystenosine, Inosine, and Cystine (administered separately). One female rat died during the observation period. The LD50 of each of three substances is at least 25,000 mg/kg body weight.
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