Registration Dossier
Registration Dossier
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EC number: 200-609-3 | CAS number: 65-45-2
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Significant methodological deficiencies.
Data source
Reference
- Reference Type:
- publication
- Title:
- 3-Hydroxylation of salicylamide in mice
- Author:
- Howell SR, Kotkoskie LA, Dills RL, Klaassen CD
- Year:
- 1 988
- Bibliographic source:
- J. Pharm. Sci. 1988, 77(4), 309-313
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The concentrations of salicylamide and its metabolites in blood and urine were determined at various time points after intraperitoneal injection of salicyclamide into mice.
- GLP compliance:
- no
Test material
- Reference substance name:
- Salicylamide
- EC Number:
- 200-609-3
- EC Name:
- Salicylamide
- Cas Number:
- 65-45-2
- Molecular formula:
- C7H7NO2
- IUPAC Name:
- salicylamide
- Details on test material:
- - Name of test material (as cited in study report): salicylamide
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sasco, Omaha, NE, USA
- Weight at study initiation: 25-30 g
- Diet (e.g. ad libitum): ad libitum Purina Laboratory Rodent Chow
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Details on exposure:
- TEST MATERIAL
- concentration (if solution): 20 mL/kg bw - Duration and frequency of treatment / exposure:
- Single exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
274.3 mg/kg bw and 548.5 mg/kg bw (2 and 4 mmol/kg bw)
- No. of animals per sex per dose / concentration:
- 274.3 mg/kg bw: 4 mice
548.5 mg/kg bw: 8 mice - Control animals:
- yes
- Positive control reference chemical:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY
- Tissues and body fluids sampled: urine, blood
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine
- From how many animals: (samples pooled or not): 4-8, pooled samples
- Method type(s) for identification: HPLC-UV (240 nm)
TREATMENT FOR CLEAVAGE OF CONJUGATES (if applicable): beta-glucuronidase: sulfatase
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- IDENTIFIED METABOLITES:
2.3-dihydroxybenzamide (2,3-DBA), 2.5-dihydroxybenzamide (gentisamide), and their sulfates and glucuronides
QUANTIFICATION IN BLOOD:
After intraperitoneal administration of salicylamide, gentisamide glucuronide and salicylamide glucuronide were the major metabolites present in blood, followed by 2,3-DBA glucuronide and salicylamide sulfate. Gentisamide and its sulfate were detected in trace amounts only whereas neither 2.3-DBA nor its sulfate were detected.
QUANTIFICATION IN URINE:
The relative amount of each metabolite in urine generally reflected its maximum concentration in blood. Gentisamide glucuronide was the most abundant metabolite, followed by 2,3-DBA glucuronide and salicylamide sulfate. Unconjugated gentisamide and 2,3-DBA only accounted for a minor proportion; salicylamide was not detected.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
After i.p. administration of salicylamide into mice, 2,3-dihydroxybenzamide, 2,5-dihydroxybenzamide (gentisamide), and its sulfates and glucuronides could be identified as metabolites of salicylamide in both blood and urine. - Executive summary:
Metabolism of salicylamide in mice was assessed after intraperitoneal administration of 274.3 and 548.5 mg/kg bw. The concentrations of salicylamide and its metabolites in blood and urine were determined at various time points using HPLC-UV. Glucuronides and sulfates were detected using glucuronidase/sulfatase treatment of samples before injection.
2.3-Dihydroxybenzamide (2,3-DBA), 2.5-dihydroxybenzamide (gentisamide), and their sulfates and glucuronides were identified besides the sulfates and glucuronides of salicylamide as major metabolites of salicylamide in blood and urine.
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