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EC number: 306-082-7
CAS number: 95912-86-0
Based on expert judgment, there is no evidence that any substance within the Long Chain Aliphatic Esters category causes carcinogenic effects.
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
Since the group concept is applied to the members of the LCAE category,
data will be generated from a representative category member 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 Long Chain Aliphatic Esters category would
be scientifically unjustified. The conclusion with regard to
classification and labelling is "data lacking".
Justification for grouping of substances and read-across
The long-chain aliphatic ester (LCAE) category covers mono-esters of a
fatty acid and a fatty alcohol. The category contains both
mono-constituent and UVCB substances. The fatty acid carbon chain
lengths range is C8 - C22 (even and uneven numbered, including
saturated, unsaturated, branched and linear chains) esterified with
fatty alcohols with chain lengths from C8 - C22 (even and uneven
numbered, including saturated, unsaturated, branched and linear) in
varying proportions to mono-esters.
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 and 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 for 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 Sections
7.1 and 13) and within Chapter 5.1 of the CSR.
For all the members within the Long Chain Aliphatic Esters (LCAE)
category there are no carcinogenicity studies available.
According to the Reach regulation (1907/2006/EC), 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 mutagen category 3 or there
is evidence from repeated dose studies that the substance is able to
induce hyperplasia and/or pre-neoplastic lesions.
There is no evidence that Long Chain Aliphatic Esters cause
carcinogenicity by a direct genotoxic mechanism, as the results of all
genotoxicity studies were negative. Furthermore, in all available
repeated dose toxicity studies and developmental studies, no evidence
for hyperplasia or preneoplastic lesions was seen.
Thus, the proposal for a carcinogenicity study would be scientifically
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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