Registration Dossier

Administrative data

Description of key information

No experimental testing and no human data on carcinogenicity are available on 3-methyl-1.5-pentanediol diacrylate.

A 90-day repeated toxicity study, performed on 3-methyl-1.5-pentanediol diacrylate, no target organ was identified leading to the classification as STOT RE. Moreover, no adverse histological changes were observed, including pre-neoplastic changes (hyperplasia or metaplasia). Moreover, 3-methyl-1.5-pentanediol diacrylate is not genotoxic: all three in vitro mutagenicity studies (bacterial reverse mutation test, in vitro mammalian cell gene mutation test, in vitro micronucleus test) were negative.

So, based on the available experimental data, 3-methyl-1.5-pentanediol diacrylate is not considered as carcinogen.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to the ECHA guidance R7A (V.5, 2016), “Carcinogens may be identified from epidemiological studies, from animal experiments and/or other appropriate means that may include (Quantitative) Structure-Activity Relationships ((Q)SAR) analyses and/or extrapolation from structurally similar substances (read-across).” and “The determination of the carcinogenic potential of a chemical is based on a Weight of Evidence approach”.

First of all, no experimental testing and no human data on carcinogenicity are available on 3-methyl-1.5-pentanediol diacrylate.

A 90-day repeated toxicity study was performed on 3-methyl-1.5-pentanediol diacrylate. This type of test can identify tissues that may be specific targets for toxicity and subsequent carcinogen effects. In this study, no target organ was identified leading to the classification as STOT RE. Moreover, no adverse histological changes were observed, including pre-neoplastic changes (hyperplasia or metaplasia).

Then, 3-methyl-1.5-pentanediol diacrylate is not genotoxic. A great deal of information concerning the possible carcinogenicity of a compound can be obtained from a battery of short-term mutagenicity assays (Bridges, 1976). All three in vitro mutagenicity studies (bacterial reverse mutation test, in vitro mammalian cell gene mutation test, in vitro micronucleus test) were performed on 3-methyl-1.5-pentanediol diacrylate and are negative, meaning that 3-methyl-1.5-pentanediol diacrylate did not induce gene mutations or structural and numerical chromosome aberrations in the in vitro models.

So, based on the available experimental data, 3-methyl-1.5-pentanediol diacrylate is not considered as carcinogen.

(Q)SAR models attempt to predict the carcinogenic hazard of diverse groups of substances. Some of (Q)SAR were used to identify a potential hazard for carcinogenicity of 3-methyl-1.5-pentanediol diacrylate (OECD QSAR TOOLBOX, OncoLogic, TOX TREE, VEGA, Danish EPA (Q)SAR database, Lazar). The results of these (Q)SAR are discussed later in the attached document (in section 13 of the IUCLID). At the end, no relevant positive prediction was found for 3-methyl-1.5-pentanediol diacrylate due to the lack of information on the tools or due to the limitations of using the tools.

Based on the available QSAR, no relevant prediction allow to consider that 3-methyl-1.5-pentanediol diacrylate could be carcinogen.