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EC number: 203-911-3
CAS number: 111-82-0
Although no specific carcinogenicity study is available on fatty acid methyl esters, the scientific weight of the evidence suggests that members of the SCAE Me category do not cause carcinogenic effects. This expert judgement takes account of the absence of genotoxicity and structural alerts for genotoxicity and carcinogenicity for all members of SCAE Me category as well as their overall low toxicity in repeated dose toxicity studies.
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 SCAE Me
category, data will be generated from representative reference
substance(s) within the category to avoid unnecessary animal testing.
Additionally, once the group concept is applied, substances will be
classified and labeled on this basis.
Based on expert judgement, a testing proposal for a
carcinogenicity study within the Short Chain Aliphatic Methyl Esters
category is not scientifically justified. The conclusion with regard to
classification and labelling is "data lacking".
Justification for grouping of substances and read-across
The short chain methyl esters category (SCAE Me) covers fatty acid
esters of methanol. The category contains both mono-constituent
substances, with fatty acid C-chain lengths ranging from C6 to C18 and
UVCB substances, composed of single methyl 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 Sections
7.1 and 13) and within Chapter 5.1 of the CSR.
For all the members within the Short Chain Aliphatic Methyl Esters
(SCAE Me) 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 Short Chain Aliphatic Methyl 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, a proposal for a carcinogenicity study is scientifically neither
required nor justified.
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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