Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 250-705-4
CAS number: 31566-31-1
Based on expert judgment, there is no evidence that members of the Glycerides 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 Glycerides 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 Glycerides category would be scientifically
Justification for grouping of substances and read-across
The Glycerides category covers aliphatic (fatty) acid esters of
glycerol. The category contains both well-defined and UVCB substances
with aliphatic acid carbon chain lengths of C2 (acetate) and C7-C22,
which are mostly linear saturated and even numbered. Some of the
substances in the category contain unsaturated fatty acids (e.g. oleic
acid in 2,3-dihydroxypropyl oleate, CAS 111-03-5 or general fatty acids
C16-22 (even) unsaturated in Glycerides, C14-18 and C16-22-unsatd., mono-
and di-, CAS 91744-43-7). Some category members contain branched fatty
acids. Branching is mostly methyl groups (e.g. isooctadecanoic acid,
monoester with glycerol, CAS 66085-00-5 or 1,2,3-propanetriyl
triisooctadecanoate, CAS 26942-95-0). In one category member the
branching cannot be precisely located (Glycerides, C16-18 and
C18-unsatd., branched and linear mono-, di- and tri, ELINCS 460-300-6).
Hydroxylated fatty acids are present in three substances (Castor oil,
CAS 8001-79-4; castor oil hydrogenated, CAS 8001-78-3 and
2,3-dihydroxypropyl 12-hydroxyoctadecanoate, CAS 6284-43-1).
Hydroxylation occurs on C12 of stearic acid in all these substances.
Acetylated chains are present in the last part of the category,
comprising fatty acids from C8 to C18 (even) and also C18 unsaturated,
additionally a C18 acetylated fatty acid is present with the acetic acid
located in C12 position (e.g. Glycerides, castor oil mono-, hydrogenated
acetates / 12-acetoxy-octadecanoic acid, 2,3-diacetoxy, CAS
736150-63-3). All glycerides build mono-, di- and tri-esters in variable
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 Glyceride 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 Glyceride 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 Glyceride
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again