Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

Administrative data

exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
Metabolism and pharmacokinetics of deuterium-labelled di-2-(ethylhexyl) adipate (DEHA) in humans
Loftus, N.J., Laird, W.J.D., Steel, G.T., Wilks, M.F. and Woollen, B.H.,
Bibliographic source:
Fd Chem. Toxic. Vol . 31, No. 9. pp. 609-614

Materials and methods

Endpoint addressed:
basic toxicokinetics
Test guideline
no guideline required
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) adipate
EC Number:
EC Name:
Bis(2-ethylhexyl) adipate
Cas Number:
Molecular formula:
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)


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:
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

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