Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
expert QSAR report
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a (Q)SAR model, with limited documentation / justification, but validity of model and reliability of prediction considered adequate based on a generally acknowledged source

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2017

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

Incentive

Evaluation of the toxicokinetic properties (i.e. absorption, metabolism, distribution and elimination) of the substance is a requirement. The information can contribute in the understanding of the toxicological profile and assist in testing

strategy and study design.

Objective

The purpose of this study was to assess the toxicokinetic properties of ethylene dibenzoate (EGDB, CAS 94-49-5).

Methods

The toxicokinetic properties of EGDB are evaluated using free and commercially available computerized models as well as available study information on the substance itself.

Conclusions

EGDB is a mono-constituent of at least 99.4% purity and has a molecular weight of 270.28 g/mole. It is a solid at room temperature. Based on information from property profiling as well on information on studies on EGDB, the following statements can be made:

- Oral absorption: the bioavailability of EGDB, following dissociation of the salt in the Gastro- Intestinal tract, is considered to be high via oral route. A provisional absorption rate of 100% is set for the oral route.

- Dermal absorption: Dermal absorption of EGDB is expected to be high. A provisional absorption rate of 100% is set for the dermal route.

- Respiratory absorption: Likelihood of exposure via inhalation is low considering the very low vapor pressure. Exposures are only possibly to aerosols that will deposit mainly in upper airways, and will be subsequently swallowed after mucociliary transportation to pharynx. No principal difference is therefore expected in absorption between exposures via inhalation route and oral route as high in respiratory tract. Absorption via inhalation therefore also set to 100%.

- It is predicted that EGDB is rapidly absorbed, distributed over the whole body and excreted again

- EGDB has no bioaccumulation potential (LogPow 3.75 (just above 3) and readily biodegradable).