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Based on expert judgment, there is no evidence that members of the Polyol category cause carcinogenicity.
According to Article 13 of Regulation (EC) No. 1907/2006 "General
Requirements for Generation of Information on Intrinsic Properties of
substances", information on intrinsic properties of substances may be
generated by means other than tests e.g. from information from
structurally related substances (grouping or read-across), provided that
conditions set out in Annex XI are met. Annex XI, "General rules for
adaptation of this standard testing regime set out in Annexes VII to X”
states that “substances whose physicochemical, toxicological and
ecotoxicological properties are likely to be similar or follow a regular
pattern as a result of structural similarity may be considered as a
group, or ‘category’ of substances. This avoids the need to test every
substance for every endpoint". Since the group concept is applied to the
members of the Polyol category, data will be generated from data for
reference source substance(s) to avoid unnecessary animal testing.
Additionally, once the group concept is applied, substances will be
classified and labelled on this basis.
Based on expert judgement, a testing proposal for a
carcinogenicity study within the Polyol category would be scientifically
Justification for grouping of substances and read-across
The polyol esters category comprises of 51 aliphatic esters of
polyfunctional alcohols containing two to six reactive hydroxyl groups
and one to four fatty acid chains. The category contains mono
constituent, multi-constituent and UVCB substances with fatty acid
carbon chain lengths ranging from C5 - C28, which are mainly saturated
but also mono unsaturated C16 and C18, polyunsaturated C18, branched C5
and C9,branched C14 – C22 building mono-, di-, tri-, and tetra
esterswith an alcohol (i.e.polyol). Fatty acid esters are generally
produced by chemical reaction of an alcohol (e.g. pentaerythritol,
trimethylolpropane or neopentylglycol) with an organic acid (e.g. oleic
acid) in the presence of an acid catalyst (Radzi et al., 2005). The
esterification reaction is started by a transfer of a proton from the
acid catalyst to the acid to form an alkyl oxonium ion. The acid is
protonated on its carbonyl oxygen followed by a nucleophilic addition of
a molecule of the alcohol to a carbonyl carbon of acid. An intermediate
product is formed. This intermediate product loses a water molecule and
a proton to give an ester (Liu et al, 2006; Lilja et al., 2005; Gubicza
et al., 2000; Zhao, 2000).The final products of esterification of an
alcohol and fatty acids are esters ranging from monoesters to
The available data allows for an accurate hazard and risk
assessment of the category and the category concept is applied for the
assessment of environmental fate, environmental and human health
hazards. Thus where applicable, environmental and human health effects
are predicted from adequate and reliable data for source substance(s)
within the group by interpolation to the target substances in the group
(read-across approach) applying the group concept in accordance with
Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for
each specific endpoint the source substance(s) structurally closest to
the target substance is/are chosen for read-across, with due regard to
the requirements of adequacy and reliability of the available data.
Structural similarities and similarities in properties and/or activities
of the source and target substance are the basis of read-across.
A detailed justification for the grouping of chemicals and
read-across is provided in the technical dossier (see IUCLID Section 13)
and within Chapter 5.1 of the CSR.
In accordance with Column 2 of Annex X, 8.9.1, of Regulation (EC)
No 1907/2006, a carcinogenicity study may be proposed by the registrant
or may be required by the Agency in accordance with Articles 40 or 41
if: the substance has a widespread dispersive use or there is evidence
of frequent or long-term human exposure, and the substance is classified
as germ cell mutagen category 2 or there is evidence from the repeated
dose study(ies) that the substance is able to induce hyperplasia and/or
There is no evidence that the members of the Polyol category
induce gene mutations in bacteria or chromosome aberrations in mammalian
cells, as the results of all genotoxicity studies were consistently
negative. Furthermore, in the available repeated dose toxicity studies
and developmental studies, no substance-related increases in the
incidence of hyperplasia or pre-neoplastic lesions were observed.
The available and relevant studies do not indicate that the
members of the Polyol category fulfil the criteria for classification as
germ cell mutagen or that they are able to induce hyperplasia and/or
pre-neoplastic lesions. Therefore, the conditions for a carcinogenicity
study to be proposed or required set out in Column 2 of Annex X, 8.9.1,
are not met. Furthermore, the weight of evidence from all available
information leads to the conclusion that the members of the Polyol
category are not carcinogenic. Therefore, a carcinogenicity study is
scientifically unjustified, will not be proposed and shall be omitted
for reasons of animal welfare in accordance with Annex XI, 1.2, of
Regulation (EC) 1907/2006.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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