Registration Dossier
Registration Dossier
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EC number: 203-090-1 | CAS number: 103-23-1
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Metabolism and pharmacokinetics of deuterium-labelled di-2-(ethylhexyl) adipate (DEHA) in humans
- Author:
- Loftus, N.J., Laird, W.J.D., Steel, G.T., Wilks, M.F. and Woollen, B.H.,
- Year:
- 1 993
- Bibliographic source:
- Fd Chem. Toxic. Vol . 31, No. 9. pp. 609-614
Materials and methods
- Endpoint addressed:
- basic toxicokinetics
Test guideline
- Qualifier:
- no guideline required
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- DEHA was obtained from ICI Chemical and polymers (UK)
purity [2H10]DEHA > 99% and was prepared at Zeneca Central Toxicology Laboratory (Cheshire, UK)
Constituent 1
Method
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- Six male volunteers were received 46 mg [2H10]DEHA (purity >99%) formulated in
corn , oil (in a total volume of 0 .5 cm3) and dosed as a gelatin capsule. - Exposure assessment:
- measured
- Details on exposure:
- Blood samples (10 cm3) were taken from this cannula pre-dose and 0 .5, 1, 2, 3, 4, 5, 6, 8 and 12 hr post-administration.
Further samples were taken by venepuncture at 24 and 31 hr.
Urine collections were made at 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72 and 72-96 hr post-administration.
Results and discussion
- Results:
- No adverse effects were observed in any of the volunteers, and there were no significant changes in biochemical or haematological parameters measured before or after administration of [2H10]DEHA . After oral administration, unconjugated [2H10]EHA was the only compound measurable in plasma; [2H10] EH was detected but the levels were below the limit of quantification. [2H10 EHA] was also the principal metabolite eliminated in urine, followed by [2H5]5-OH-EHA, [2H5]diEHA, [2H5]EH and [2H5]keto-EHA. The rates of elimination were similar for all metabolites (mean elimination half life of 1.5 hr).
Applicant's summary and conclusion
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