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EC number: 204-635-6 | CAS number: 123-56-8
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Pharmacokinetics of orally administered succinimide in man
- Author:
- Schulte K. E.
- Year:
- 1 978
- Bibliographic source:
- European Journal of Drug Metabolism and Pharmacokinetiks, No.:3, p.161-163
Materials and methods
- Objective of study:
- absorption
- distribution
- other: elimination
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The absorption and elimination of succinimide have been investigated in healthy volunteers after the oral administration of a single dose of 10 g of succinimide per person. Succinimide was spectrophotometrically determined in serum by treating succinimide with hydroxylamine at pH 8.3 and measuring the absorbance of the resultant M-hydroxysuccinimide at 260 nm.
- GLP compliance:
- no
Test material
- Reference substance name:
- Succinimide
- EC Number:
- 204-635-6
- EC Name:
- Succinimide
- Cas Number:
- 123-56-8
- Molecular formula:
- C4H5NO2
- IUPAC Name:
- pyrrolidine-2,5-dione
- Details on test material:
- no additional data available
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Three healthy volunteers. Age and weight: Nr.1: 35 years and 77 kg; Nr.2: 56 years and 95 kg; Nr.3:44 years and 65 kg.
Administration / exposure
- Route of administration:
- other: oral in solution (100 mL)
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Three healthy volunteers were given 10 g of succinimide in solution (100 mL). Concentrations have been adjusted to a dose of 10g/75 kg i.e. 0.133 g/kg. The subjects had fasted overnight. - Duration and frequency of treatment / exposure:
- single administration
Doses / concentrations
- Dose / conc.:
- 10 other: g in solution (100 mL)
- No. of animals per sex per dose / concentration:
- 3 healthy volunteers
- Control animals:
- no
- Positive control reference chemical:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY
- Tissues and body fluids sampled: serum
- Time and frequency of sampling: bebore administration, 0.5, 1, 2, 4, 6, 8 and 24 hours thereafter - Statistics:
- Elimination rate constants (kel) were calculated from the lines fitted, by the method of least squares , to the log blood concentration values versus time from 1 to 10 h, inclusive. The intercept gave the value of the apparent initial concentration (C0). Absorption rate constants (ka) were obtained by forcing a line through the residual concentration value at 0.5 h and the value of C0 at t=0. The maximum concentration (cmax) and the time to reach this maximum (tmax) were calculated from ka and kel as described; the fraction of the dose entering the body was assumed to be 1.
Results and discussion
- Preliminary studies:
- no
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Adsorption rate constant (ka) = 2.83 (1/h)
- Type:
- other: elimination serum
- Results:
- Elimination rate constants (kel) = 0.092 (1/h)
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Adsorption rate constant (ka) = 2.83 (1/h)
- Details on distribution in tissues:
- no data
- Details on excretion:
- no data
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- other: distribution coefficient: 0.63 ml/g
- Toxicokinetic parameters:
- C(time): 0h: 0.210 mg/ml
- Toxicokinetic parameters:
- Cmax: 0.187 mg/ml
- Toxicokinetic parameters:
- Tmax: 1.25 h
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- no data
Applicant's summary and conclusion
- Conclusions:
- Comparison of the pharmacokinetic parameter values obtained for man and for rats after the oral administration of similar doses of succinimide shows that in man absorption is faster and elimination is slower. As a consequence, the maximum blood concentration occurs earlier and is higher. The distribution coefficient lies in the range which has been determined for other water soluble drugs. An accumulation of succinimide in organs or tissues is therefore unlikely.
- Executive summary:
The absorption and elimination of succinimide have been investigated in healthy volunteers after the oral administration of a single dose of 10 g succinimide per person. Succinimide was spectrophotometrically determined in serum by treating succinimide with hydroxylamine at pH 8.3 and masuring the absorbance of the resultant N-hydroxysuccinimide at 260 nm.
Comparison of the pharmacokinetic parameter values obtained for man and for rats after the oral administration of similar doses of succinimide shows that, in man absorption is faster and elimination is slower. As a consequence, the maximum blood concentration occurs earlier and is higher. The distribution coefficient lies in the range which has been determined for other water soluble drugs. An accumulation of succinimide in organs or tissues is therefore unlikely.
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