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Diss Factsheets
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EC number: 215-818-5 | CAS number: 1420-53-7
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION
- Author:
- Delatte MS
- Year:
- 2 010
- Bibliographic source:
- NDA 202245, DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH
Materials and methods
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Codeine
- EC Number:
- 200-969-1
- EC Name:
- Codeine
- Cas Number:
- 76-57-3
- Molecular formula:
- C18H21NO3
- IUPAC Name:
- Codeine
1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Methylcellulose USP and Reverse Osmosis/Deionised Water
- Duration of treatment / exposure:
- three consecutive days
- Frequency of treatment:
- daily
- Post exposure period:
- bone marrow harvest occurred ca. 3 hours after the last dose administration (test material treated rats)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 other: mg/kg
- Dose / conc.:
- 100 other: mg/kg
- Dose / conc.:
- 200 other: mg/kg
- Dose / conc.:
- 400 other: mg/kg
- No. of animals per sex per dose:
- 5 with the exception of the 50 mg/kg dose level (only 5 females) and the 400 mg/kg dose level (only 5 males)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- yes: cyclophosphamide; ethylmethanesulphonate
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
- Mortality: Mortalities were reported in males at 400 mg/kg/day (n=3/5) and in females at 200 mg/kg (n=6/8). Note that three males and five females from these dose groups were found dead prior to the scheduled sacrifice. On day 2, the male animals were found dead either immediately after treatment (n=1) or one hour after treatment (n=2). The five females were found dead one hour after treatment on day 2. A single female from the 200 mg/kg/day group was euthanised prior to the scheduled sacrifice during the morning of day 2 (prior to
treatment).
- Clinical observations: A variety of clinical signs were observed in treated animals. These signs varied in regard to the incidence in which they were reported and the treatment days on which they were observed. The clniical signs were generally produced in a dose-related manner in treated animals. Acorss sexes, the clinical signs included convulsions, yellow harircoat-perineal area, protruding eyes, hypoactivity, and swollen nose. In females, clear oral discharge, red hair coat-nose, recumbant-sternal, lacrimation, rough hair coats, hunched posture, irregular respiration, cold t touch, and hyperactivity were also observed.
- Micronucleus assay: The test material did not produce a statistically significant increase in the averaged % micronucleated polychromatic erythrocytes and ratio of PCE:NCE when compared to control.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test the test material was negative for genotoxicity. The test material did not produce statistically significant increases in the averaged % micronucleated polychromatic erythrocytes and the ratio of PCE:NCE when compared to the control.
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