Registration Dossier
Registration Dossier
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EC number: 252-488-1 | CAS number: 35285-69-9
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given.
Data source
Reference
- Reference Type:
- publication
- Title:
- p-Hydroxybenzoic Acid Esters as Preservatives III.
- Author:
- Jones, P.S. et al.
- Year:
- 1 956
- Bibliographic source:
- J Am Pharm assoc Sci Ed 45, 265-273
Materials and methods
- Objective of study:
- excretion
- metabolism
- Principles of method if other than guideline:
- Dogs were treated with the test substance by intravenous application. After 48 h, excretion of the test substance and its metabolites via urine was investigated.
- GLP compliance:
- no
Test material
- Reference substance name:
- Propyl 4-hydroxybenzoate
- EC Number:
- 202-307-7
- EC Name:
- Propyl 4-hydroxybenzoate
- Cas Number:
- 94-13-3
- Molecular formula:
- C10H12O3
- IUPAC Name:
- propyl 4-hydroxybenzoate
- Details on test material:
- - Name of test material (as cited in study report): propyl p-hydroxybenzoate
- Analytical purity: no data
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- dog
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- not specified
Doses / concentrations
- Dose / conc.:
- 50 mg/kg bw (total dose)
- No. of animals per sex per dose / concentration:
- at least 3
- Control animals:
- no
Results and discussion
Main ADME resultsopen allclose all
- Type:
- metabolism
- Results:
- The major part of the test substance was recovered in urine as free p-hydroxybenzoic acid and as conjugate with glucuronic acid.
- Type:
- excretion
- Results:
- 94% of the test substance were recovered within 48 h in urine.
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- 48 h after treatment, 94% of the test substance was recovered in urine.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- 0.1% of the test substance were found in urine after intravenous injection. The major part of the recovered test substance was found as free p-hydroxybenzoic acid (26.0%) and as conjugate with glucuronic acid (22.6%).
Applicant's summary and conclusion
- Conclusions:
- no bioaccumulation potential based on study results
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