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EC number: 931-801-1
CAS number: -
RA-S CAS 124-26-5, OECD 423, oral rat: LD50cut off 5000 mg/kg bw (ATC method)RA-S CAS 112-84-5, OECD 436, inhal. rat: LC50 >2.8 mg/L (ATC method)RA-S CAS 112-84-5, OECD 402 dermal rat: LD50 >2000 mg/kg bw (limit test)
No test data for oleamide is available for acute toxicity testing.
Therefore, read-acrosses from structurally related substances,
stearamide (CAS 124-26-5) and erucamide (CAS 112-84-5), are included for
Strearamide is the fatty acid amide resulting from amidation of stearic
acid, the saturated C18-carbon acid. The only difference to oleic acid
is the absence of the C=C double bond at position 9 of the carbon chain.
Like oleamide (Cooper, 1995), stearamide will be cleaved by
gastrointestinal fluids. Stearic acid can be desaturated to oleic acid
within the body (Emken, 1994), and both metabolites will follow the same
metabolical pathways (compare toxicokinetics, metabolism and
distribution). Like oleic acid, stearic acid is a common part of our
daily nutrition (Beare-Rogers, 2001). Furthermore, it is an element of
many molecules with endogenous functions.
Erucamide is the fatty acid amide resulting from the amidation of erucic
acid. Erucic acid is a mono-unsaturated fatty acid with a carbon chain
consisting of 22 carbon atoms with a double bond at position 13
(omega-9) of the carbon chain (cis-docos-13-enoic acid). Comparable to
oleamide and stearamide it is not classified in Annex I of Directive
67/548/EEC, and does not have to be self-classified according to the
available experimental data. Erucic acid is also present in various oils
and fats which are part of our diets (20-40% in oils from mustard seeds
and up to 50% in original high erucic rapeseed oil, <2% in low erucic
acid rapeseed oil; Beare-Rogers, 2001) and will also be broken down into
shorter-chain fatty acids in the process of beta-oxidation. One of the
most famoust uses is in Lorenzo's oil, a 4:1 mixture of the triglyceride
forms of oleic and erucic acid, i.e. an investigational drug used for
the treatment of adrenoleukodystrophy, for which an U.S. Patent was
established. Testing of erucamide for acute oral toxicity following OECD
guideline 423 as limit test with a starting dose of 2000 mg/kg bw,
performed by the same testing facility as for stearamide, revealed
comparable results to stearamide: no mortality occurred, no signs of
systemic toxicity were observed, and animals showed the expected gains
Therefore, these substances are considered to have toxicological
characteristics comparable to each other and to oleamide. Considering
animal welfare reasons, read-across from tests for acute toxicity
conducted with stearamide (CAS 124-26-5) and erucamide (CAS 112-84-5) is
reasonable and justified.
There is data available from an acute oral toxicity study following OECD
Guideline 423 (Acute Toxic Class Method) in form of a limit test with
stearamide (Sanders, 2000). A starting dose of 2000 mg/kg bw was
subsequently applied to 3 animals of each sex. No mortality occurred
either in the females nor in the males, no signs of systemic toxicity
were observed, and the animals showed the expected gain in bodyweight
during the study. Therefore, according to the scheme outlined in Annex
2d of OECD guideline 423 the LD50 cut-off value for acute oral toxicity
was determined to be 5000 mg/kg bw.
The acute inhalation toxicity test was performed according to OECD
Guideline 436 (Acute Toxic Class Method) with the maximum attainable
aerosol concentration of erucamide still ensuring particles with a
respirable MMAD as recommended in the guideline (Pothman, 2010). In the
study the animals were nose-only exposed for 4 hours to an aerosol with
MMADs ranging from 3.02 to 3.84 µm and a concentration of 2.8 mg/L. No
mortality occurred, and the only effects observed during the 14-day
observation period were ruffled fur one hour after the end of exposure
and slight body weight loss from day 1 to day 2. No effects were
observed from day 2 onwards. Therefore, the LC50 was established to be
>2.8 mg/L for a 4-hour exposure period. According to OECD Guideline 436,
Annex 5d for Acute Inhalation Toxicity testing with a starting
concentration of 5 mg/L/4h for dusts and mists, the LC50 cut-off for
acute inhalation toxicity can even be defined as "∞", as the starting
dose already represented the maximum technically attainable
concentration, and under handling conditions no higher concentration of
a comparable respirable size will occur.
The acute dermal toxicity study with erucamide, designed as limit test,
was performed according to OECD Guideline 402 (Braun, 2010). Five rats
per sex were exposed for 24 hours to a dose of 2000 mg/kg bw under
semicocclusive conditions. After exposure the treated skin sites were
cleaned with lukewarm water and the dermal reactions were assessed.
During the 14-day observation period no mortality occurred; no signs of
systemic toxicity were observed, and the animals showed the expected
gains of body weight. Local observations at the exposure site in form of
slight desquamation were made in one male on observation days 7 and 8;
no dermal effects were observed in th females. Therefore, the LD50 for
acute dermal toxicity was determined to be >2000 mg/kg bw.
Based on the results from structurally related substances, oleamide does
not have to be classified for acute toxicity according to the DSD and
the criteria of the CLP regulation.
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