Registration Dossier

Diss Factsheets

Toxicological information

Specific investigations: other studies

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

A computational network model that integrates 18 in vitro, high-throughput screening assays measuring estrogen receptor (ER) binding, dimerization, chromatin binding, transcriptional activation, and ER-dependent cell proliferation. The network model uses activity patterns across the in vitro assays to predict whether a chemical is an ER agonist or antagonist, or is otherwise influencing the assays through a manner dependent on the physics and chemistry of the technology platform (“assay interference”).
The chemical structure of eugenol was investigated in the Derek Nexus (Q)SAR system for potential structural alerts for oestrogenicity and thyroid toxicity. In both cases the prediction was negative and it is concluded that eugenol does not have a potential for endocrine disruption.
A validated (standardized) estrogen receptor (ER) competitive-binding assay was used to determine the ER affinity for Eugenol. Uteri from ovariectomized Sprague-Dawley rats were the ER source for the competitive-binding assay. Eugenol was demonstrated to have no binding affinity for the estrogen receptor.
A two-generation reproductive toxicity study on a read-across substance (isoeugenol) showed no effects on any other reproductive parameters throughout both generations. Sperm parameters and vaginal cytology were unchanged in the F0 and F1 generations.

Additional information

A computational network model that integrates 18 in vitro, high-throughput screening assays measuring estrogen receptor (ER) binding, dimerization, chromatin binding, transcriptional activation, and ER-dependent cell proliferation. The network model uses activity patterns across the in vitro assays to predict whether a chemical is an ER agonist or antagonist, or is otherwise influencing the assays through a manner dependent on the physics and chemistry of the technology platform (“assay interference”).

Eugenol is predicted negative for estrogen endocrine disruptor potential in a battery of 18 in vitro high-throughput assays. Isoeugenol and methyleugenol are also predicted to have no estrogen endocrine disruptor potential.

The chemical structure of eugenol was investigated in the Derek Nexus (Q)SAR system for potential structural alerts for oestrogenicity and thyroid toxicity. In both cases the prediction was negative and it is concluded that eugenol does not have a potential for endocrine disruption.

A validated (standardized) estrogen receptor(ER) competitive-binding assay was used to determine the ER affinity for Eugenol. Uteri from ovariectomized Sprague-Dawley rats were the ER source for the competitive-binding assay. Eugenol was demonstrated to have no binding affinity for the estrogen receptor.

A two-generation reproductive toxicity study on a read-across substance (isoeugenol) showed no effects on any other reproductive parameters throughout both generations. Sperm parameters and vaginal cytology were unchanged in the F0 and F1 generations.

Based on good quality high-throughput data, a (Q)SAR prediction and a validated in vitro estrogen receptor binding assay generated on the substance itself, and on good quality in vivo data generated on a close structural analogue, it is concluded that eugenol has no potential for endocrine disruptor activity.