Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

According to the REACh Regulation, Annex XI.3.2a, testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report.

The manufacturer or importer demonstrates and documents that all of the following conditions are fulfilled: (i) the results of the exposure assessment covering all relevant exposures throughout the life cycle of the substance demonstrate the absence of or no significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI Section 3.5(ii), a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes; (iii) the comparison of the derived DNEL or PNEC with the results of the exposure assessment shows that exposures are always well below the derived DNEL or PNEC.

As a basis for exposure-based waiving, the TTC concept as devised by Munro et al. [1] is applied.

Di-2 -EHTDG is predicted to fall within Cramer Class I (low hazard).

Within Cramer class I, the 5th-percentile NOEL have been identified from chronic oral studies or other oral studies (e.g., developmental toxicity) if they were more sensitive. The majority of NOELs were defined by studies in the rat.

The generic oral NOEL applicable to Di-2 -EHTDG (Class I) is 3.0 mg/kg bw/day. This generic NOEL is based on the most sensitive endpoint and also covers reproductive and developmental toxicity.

[1] Munro, I.C.et al.(1996) Correlation of Structural Class with No-Observed-Effect Levels: A Proposal for Establishing a Threshold of Concern.Food Chem. Toxicol.34829-867


Short description of key information:
Reproductive toxicity testing has not been performed, because no significant exposure occurs in all scenarios of manufacure and identified uses.

Justification for classification or non-classification

Additional information