Bis(2-ethylhexyl) adipate

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:

1993

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

Test material information

Constituent 1

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)

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).