Registration Dossier
Registration Dossier
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EC number: 200-589-6 | CAS number: 64-67-5
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Old study covering only the metabolism, not comprehensive regarding all the possible metabolites but the partial results are valid.
Data source
Reference
- Reference Type:
- publication
- Title:
- The synthesis of mercapturic acids from diethyl sulphate and di-n- propyl sulphate in the rat
- Author:
- Kaye CM
- Bibliographic source:
- Xenobiotica 4(6): 329-336
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline available at the time of the study.
Determination of some metabolites of DES in the urine of rats by paper chromatography - GLP compliance:
- not specified
Test material
- Reference substance name:
- Diethyl sulphate
- EC Number:
- 200-589-6
- EC Name:
- Diethyl sulphate
- Cas Number:
- 64-67-5
- Molecular formula:
- C4H10O4S
- IUPAC Name:
- diethyl sulfate
- Details on test material:
- Supplier: BDH chemicals (UK)
DES was redistilled at 136° and 60 mmHg before use.
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- other: CFE
- Sex:
- male
Administration / exposure
- Route of administration:
- other: subcutaneous, ip and gavage
- Vehicle:
- arachis oil
- Duration and frequency of treatment / exposure:
- 1 treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1 mL of a solution at 5% (v/v) corresponding to ca 59 mg/ rat, by sc injection
No detail about the dose for the ip and oral routes.
- No. of animals per sex per dose / concentration:
- 78 animals for the sc treatment, no data for the other routes
- Control animals:
- not specified
Results and discussion
- Preliminary studies:
- no data
Main ADME results
- Type:
- metabolism
- Results:
- identification of ethylmercapturic acid, a sulfoxide compound and no S-ethyl-cysteine in the urine
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- not tested
- Details on distribution in tissues:
- not tested
- Details on excretion:
- No comprehensive evaluation of the excretion process has been performed. Some metabolites of DES are excreted in the 24 h urine.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- identification of ethylmercapturic acid, a sulfoxide compound and no S-ethyl-cysteine in the urine disregarding the route of administration.
An attempt to quantify the ethylmercapturic acid was made: it would correspond to 2.4% of the DES administered.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no data
identification of ethylmercapturic acid, a sulfoxide compound and no S-ethyl-cysteine in the urine disregarding the route of administration. - Executive summary:
Paper chromatography of urine of rats dosed subcutaneously, intraperitoneally or orally with diethyl sulphate revealed the presence of ethylmercapturic acid.
After administration of diethyl sulphate to rats ethylmercapturic acid was isolated as its dicyclohexylammonium salt, in 2.4% yield from the urine.
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