Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance was not mutagenic in both bacterial reverse mutation test in the absence and the presence of metabolic activation. 


4,4-isopropylidenediphenol, ethoxylated (BPA-4EO) is currently being assessed for the purpose of the evaluation of genetic toxicity in vitro using two studies: the OECD TG 487 (Micronucleus test in human lymphocytes) and OECD TG 490 (mammalian cell gene mutation using the Thymidine kinase gene). These two studies have been planned and commissioned to Covance Laboratories Limited, Shardlow Business Park, Shardlow Derbyshire, DE72 2GD, UK.


Receipt of the draft study reports from the CRO is expected to be on February 2021.


The reason for such a delay in reference to ECHA 30 November 2020 deadline (Refs: CCH-D-2114489551-41-01/F), are explained in a separate letter, attached to this dossier. 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:
Two studies are reported to assess the genetic toxicity of the substance. These studies were considered reliable as they were conducted on the registered substance according to OECD Testing Guidelines 471. The test substance was not mutagenic in both bacterial reverse mutation tests in the absence and the presence of metabolic activation.


Justification for selection of genetic toxicity endpoint
At the request of ECHA request (decision number CCH-D-2114489551-41-01/F) two further studies are in progress, the in vitro mammalian cell micronucleus test (OECD 487) and the in vitro mammalian cell gene mutation test (OECD 490). 


These studies, have been planned and commissioned to Covance Laboratories Limited, Shardlow Business Park, Shardlow Derbyshire, DE72 2GD, UK.


Receipt of the draft study reports from the CRO is expected to be on February 2021.


The reason for such a delay in reference to ECHA 30 November 2020 deadline (Refs: CCH-D-2114489551-41-01/F), are explained in a separate letter, attached in background material. 

Justification for classification or non-classification

There is no evidence to classify the registered substance as a cell mutagen, in reference to the OECD 471 tests. Further genetic toxicity testing is ongoing (OECD 487 and OECD 490).