Registration Dossier
Registration Dossier
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EC number: 224-709-1 | CAS number: 4457-71-0
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: publication in a peer-reviewed journal with sufficiently detailed data to assess the reliability
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies in Detoxication 80. The metabolism of glycols
- Author:
- Gessner, P.K.; Parke, D.V. and Williams, R.T.
- Year:
- 1 960
- Bibliographic source:
- Biochemical Journal, Vol 74 (1960) page 1 - 5
Materials and methods
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- Urine was collected for 2 days after administering 1.5g/kg. After ether extraction the metabolite was identified as anhydride and anilide of the 3-methyl glutaric acid.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-methylpentane-1,5-diol
- EC Number:
- 224-709-1
- EC Name:
- 3-methylpentane-1,5-diol
- Cas Number:
- 4457-71-0
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 3-methylpentane-1,5-diol
Constituent 1
- Specific details on test material used for the study:
- purchased and purified, no details on quality given
viscous - Radiolabelling:
- no
Test animals
- Species:
- other: Chinchilla
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Chinchilla's with weight of 2 - 3 kg were kept on a constant diet of 60 g of rat cubes (diet 41 ; Associated London Flour Millers) and 100 ml water per day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- a total of 10g of the substance (1.5 g/kg bw) was administered to two animals.
- No. of animals per sex per dose / concentration:
- 2
- Control animals:
- no
- Details on study design:
- urine was analysed by extraction with ether which were further separated in acidic and non-polar fractions
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- 1.45g were recovered in urine and identified as the original substance from the refractive index.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- 30% of the total dose was isolated as 3-methylglutaric acid. The acid was subsequently identified by the melting points of the free acid, the anhydride and the mono-anilide.
Applicant's summary and conclusion
- Conclusions:
- Methylpentane-1,5-diol administered to chinchilla's was recovered as methylglutaric acid in the urine in an amount of 30% if the administered dose.
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