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Registration Dossier
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EC number: 203-117-7 | CAS number: 103-49-1
- 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

Specific investigations: other studies
Administrative data
- Endpoint:
- mechanistic studies
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no details of the volunteers in test and no details on the test product used
Data source
Reference
- Reference Type:
- publication
- Title:
- Note: Determination of low concentrations of dibenzylamine in human plasma and urine by gas chromatography with a nitrogen-phosphorus detector
- Author:
- Calvo MB, Pedraz JL, Domínguez-Gil
- Year:
- 1 989
- Bibliographic source:
- J Chromat 490, 206-212
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 3 volunteers received single intramuscular injection of the Cefazolin-dibenzylamin complex and plasma content and urinary excretion of dibenzylamin was determined chromatographically
- GLP compliance:
- no
- Type of method:
- in vivo
- Endpoint addressed:
- basic toxicokinetics
Test material
- Reference substance name:
- Cephaline-dbenzylamine complex
- IUPAC Name:
- Cephaline-dbenzylamine complex
- Details on test material:
- cephazoline-dibenzylamine complex
Constituent 1
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- volunteers were injected i.m. the test substance
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- not specified
- Details on exposure:
- Single i.m injection of the complex into 3 voluteers
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- single application
- Frequency of treatment:
- single application
- Post exposure period:
- determination of debenzylamine in plasma and urine in intervalls up to 36 hours post treatment (further details not given)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1250 mg/person
Basis:
- No. of animals per sex per dose:
- 3 volunteers
- Control animals:
- no
- Details on study design:
- 3 volunteers received single intramuscular injection of the Cefazolin-dibenzylamin complex and plasma content and urinary excretion of dibenzylamine was determined chromatographically
Examinations
- Examinations:
- determination of dibenzylamine in blood (plasma) and urine
- Positive control:
- no
Results and discussion
- Details on results:
- Pharmacokinetic parameters of dibenzylamine in healthy volunteers after intramuscular injections of Cephazoline-dibenzylamine complex (mean vlues)
observation time: 36 hours
The absorption rate constant .33 per hour
The half-life of dibenzylamine: 6.33 hours
t(max): 5.23 hours
C( max): 1412.6 ng/ml
Area Under the Curve (AUC): 2296..5 ng h/ml
urinary excretion: 6.73 %
According to these findings and using the normal dosage interval of 24 h, the degree of accumulation of dibenzylamine between the first dose and the steady state would be 1.07
Applicant's summary and conclusion
- Executive summary:
Pharmacokinetics of dibenzylamine was investigated by an intramuscular injection of 1250 mg of a cefazoline-dibenzylamine-complex into 3 volunteers.Blood and urine content was measured chromatographically in time intervals up to at least 36 hours.The following determinations were made: absorption rate constant .33 per hour; half-life of dibenzylamine: 6.33 hours; t(max): 5.23 hours;
C( max): 141.6 ng/ml; Area Under the Curve (AUC): 2296.5 ng h/ml; urinary excretion: 6.73 %
According to these findings and using the normal dosage interval of 24 h, the degree of accumulation of dibenzylamine between the first dose and the steady state would be 1.07 (Calvo 1989)
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