4,4'-cyclohexylidenedi-o-cresol

Biodegradation in soil

Link to relevant study record(s)

Reference

Endpoint:

biodegradation in soil: simulation testing

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because direct and indirect exposure of soil is unlikely

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Information requirement 9.2.1.3. (soil simulation testing) is waived on the basis of exposure-based waiving. More specifically - in accordance with Section 3 of REACH Annex XI, testing in accordance with Annex IX and X may be omitted on the basis of substance-tailored exposure-driven testing.
Exposure-based waiving is considered justified based on the following rationale:
• The registrant does not supply the substance (as a reacted monomer in polymers) to the EU and has never supplied the substance in unreacted form to the EU. Furthermore, there are no co-registrants and hence there is currently no substance supply to the EU;
• Previously, the registrant has only ever supplied the substance to the EU in the form of the substance being a reacted monomer in imported polymers. In this historic case, the substance was permanently embedded within the polymer matrix throughout its entire life cycle. Hence, there was no substance release (either to man or the environment) during its past life cycle. Indeed, it would not have been reasonable to expect that there would have been any substance exposure to workers, the general public or the environment following normal and reasonably foreseeable conditions of use. Furthermore, when the substance was previously supplied as a reacted monomer in polymers, the relevant polymers were handled according to the conditions set out in Article 18(4)(a) to (f) during all manufacturing and production stages including the waste management of the substance during these stages;
• The likelihood of depolymerization (and back-formation) of the polymer to the substance monomer is negligible;
• A hypothetical, worst-case exposure based on previous EU use of the polymer demonstrates the absence of or no significant exposure to the registered substance throughout the lifecycle of the polymer. This exposure assessment has been conducted even though the EU supply level for the substance is zero, even though the substance has only ever been supplied as a reacted monomer in previously imported polymers, and even though analysis of residual levels in the previously imported polymer have been determined to be below 0.1 %.
• There have never been any professional or consumer uses of the substance.
A more detailed justification of these points is included in the attached justification document. Please also refer to the various assessment reports as included in section 13.2.

Furthermore, and in accordance with column 2 of REACH Annex IX, information requirement 9.2.1.3, a study does not need to be conducted if direct and indirect exposure of soil is unlikely. Both direct and indirect exposure to the soil is unlikely and hence it is not considered necessary to perform a study.

Additionally, and in accordance with section 9.2 of Column 2 of REACH Annex IX, further degradation studies are only needed if indicated as necessary based on the result of Chemical Safety Assessment. For this registration, the Chemical Safety Assessment does not indicate a need for such further studies. The available data are adequate for classification and labelling purposes and PBT assessment. Moreover, the substance is hydrolytically stable and available biodegradation in water screening tests indicate that the substance will not degrade and hence there will be no degradation products to test.

Overall, it is therefore considered justified to omit the study on sediment simulation testing as included under section 9.2.1.3. of REACH Annex IX.

Transformation products:

not measured

Description of key information

The endpoint soil simulation testing is waived in accordance with Section 3 of REACH Annex XI (substance-tailored exposure-driven testing) due to a demonstrable lack of exposure to the substance in the EU to either man or the environment.

 

In accordance with column 2 of REACH Annex IX (information requirement 9.2.1.3) is additionally waived since direct and indirect exposure of soil is unlikely.

 

Moreover, and in accordance with section 9.2 of Column 2 of REACH Annex IX, further degradation studies are only needed if indicated based on the result of the Chemical Safety Assessment. For this registration, the Chemical Safety Assessment does not indicate a need for these studies. The available data are adequate for classification and labelling purposes and PBT assessment. Moreover, the substance is hydrolytically stable and available biodegradation in water screening tests indicate that the substance will not degrade and hence there will be no degradation products to test.

 

Therefore, soil simulation testing - specified in section 9.2.1.3 of Annex IX - is not considered to be necessary.