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EC number: 203-911-3
CAS number: 111-82-0
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.
Table: Endpoint repeated dose toxicity
NOAEL [mg/kg bw/day]
(a) Category members subject to the REACh Phase-in registration deadline
of 31 May 2013 are indicated in bold font.
(b) Substances that are either already registered under REACh or not
subject to the REACh Phase-in registration deadline of 31 May 2013 are
indicated in normal font.
(c) Surrogate substances are either chemicals forming part of a related
category of structurally similar fatty acid esters or
precursors/breakdown products of category members (i.e. alcohol and
fatty acid moieties). Available data on these substances are used for
assessment of (eco )toxicological properties by read-across on the same
basis of structural similarity and/or mechanistic reasoning as described
below for the present category.
For all category members registered under REACh a full data set for each
endpoint is provided. For substances not subject to the current REACh
Phase-in registration, lack of data for a given endpoint is indicated by
Methyl laurate (CAS 111-82-0) was tested for oral toxicity in rats in an
OECD 422 combined repeated dose and reproductive toxicity screening test
under GLP conditions (MHLW, 2000). 12 male and female Crj:CD (SD) rats
per dose were administered doses of 0, 250, 500 and 1000 mg/kg/day by
gavage. The animals were mated. The test material was administered to
females from 14 days before mating until day 3 of lactation and to males
for 45 days. Terminal kill was on day 45 for males and on day 4 of
lactation for females. The test substance showed no general
toxicological effects in either sex. There were no clinical observations
attributable to the administration of test substance and there was no
mortality in any of the groups. No effects were observed in terms of
body weights, food consumption, haematology, blood chemistry, organ
weight, necropsy or histopathological findings. Therefore, under the
experimental conditions of the study the NO(A)EL for methyl laurate for
repeated dose toxicity after oral administration is 1000 mg/kg bw/day in
The substance Fatty acids, C16-18 and C18-unsatd., Me esters (CAS
67762-38-3) was studied for oral toxicity in rats in an OECD 422
combined repeated dose and reproductive/developmental toxicity screening
test under GLP conditions (Allan, 2010). A total of 80 (40 males and 40
females) Sprague-Dawley rats were allocated to four groups, three of
which received the test item at doses of 100, 300 and 1000 mg/kg bw/day
while the other group received the vehicle (corn oil) by oral route
(gavage) once daily at 5 mL/kg. Animals were dosed for 2 weeks prior to
pairing, during pairing, during gestation and until at least day 4
post-partum for females or until sacrifice for non-pregnant females and
until necropsy for males following 4 weeks of treatment. No
substance-related effects were observed. Therefore, the NO(A)ELs for
reproductive performance of males and females are considered to be 1000
mg/kg/day in each case.
Ethyl ester - Repeated dose toxicity:
oral subchronic NOAEL for rats: 5500 mg/kg bw/day
A subchronic oral feeding study (Bookstaff, 2004) was performed with
ethyl oleate (CAS 111-62-6) according to the 1993 FDA draft "Redbook II"
guidelines (Toxicological Principles for the Safety Assessment of Direct
Food Additives and Color Additives Used in Food). The study was
performed equivalent to OECD Guideline 408. The purpose of the study was
to determine the safety of ethyl oleate (EO) in a subchronic feeding
study in Sprague-Dawley rats. EO was mixed into AIN-93G purified diet at
levels of 0, 3.3, 6.7, and 10% by weight (approx. 0, 1900, 3800 and 6000
mg/kg bw/day). All diets were calorie- and fat-matched using high oleic
safflower oil (HOSO) as the control fat. There were 20 male and 20
female rats per group. EO in the diet was well tolerated and there were
no toxicologically significant findings in any of the measured
parameters (clinical observations, body weight gains, appearance of the
faeces, ophthalmic examinations, haematology, clinical chemistry,
urinalysis, organ weights, histopathology, or male and female
reproductive assessments). The subchronic oral NOAEL was determined to
be 10% ethyl oleate, which corresponds to approximately 5500 mg/kg
bw/day when administered by daily feeding to rats for 91-days.
Butyl ester - Repeated dose toxicity:
2 -year NOAEL for rats: 6000 mg/kg bw/day
A 2-year feeding study was performed with butyl stearate (CAS 123-95-5)
comparable to OECD Guideline 452 (Smith, 1953, summarized by Elder,
1985). Groups of 16 male Sprague-Dawley rats received daily doses of 0,
0.01, 0.05, 0.25, 1.25 and 6.25% in the diet. Based on absence of
abnormalities in clinical signs, mortality, body weight, food
consumption, haematology, clinical chemistry, gross pathology, organ
weights and histopathology the chronic NOAEL was found to be 6000 mg/kg
There are no data available on the repeated dose toxicity after dermal
application and inhalation of the category members.
In summary, all available data do not indicate any toxicological hazard
after repeated exposure via the oral route.
There are no reliable data available on the repeated dose toxicity after
dermal application and inhalation of the category members.
A detailed reference list is provided in the technical dossier (see
IUCLID, section 13) and within CSR.
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 SCAE Me 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.
Therefore, based on the group concept, the available data on repeated
dose toxicity do not meet the classification criteria according to
Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore
conclusive but not sufficient for classification.
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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