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EC number: 240-369-7
CAS number: 16260-27-8
No repeated dose toxicity study with zinc ditetradecanoate is
available, thus the repeated dose toxicity will be addressed with
existing data on the entities formed upon dissolution of zinc
ditetradecanoate, namely zinc and tetradecanoate.Since the naturally
occurring fatty acid tetradecanoic acid (aka Myristic acid) is void of
any human health hazard potential, the hazard assessment will be derived
based on the toxicological information for zinc and the human life-time
NOAEL of 0.83 mg/kg bw/day will be used further.
From studies in which humans were supplemented with zinc (as zinc
gluconate) it was concluded that women are more sensitive to the effects
of high zinc intake and that a dose of 50 mg Zn/day is the human NOAEL.
This corresponds to a daily exposure of 0.83 mg Zn/kg bw. At the LOAEL
of 150 mg Zn/day, clinical signs and indications for disturbance of
copper homeostasis have been observed. Studies conducted on animals are
not discussed here, since information on human experience are considered
of higher relevance for hazard assessment purposes and should take
precedence over animal studies. For further information on the toxicity
of zinc, please refer to the relevant sections in the IUCLID and CSR.
According to Regulation (EC) No 1907/2006 Annex V substances
obtained from natural sources and not modified such as vegetable fats
and oils as well as fatty acids from C6 to C24 and their potassium,
sodium, calcium and magnesium salts are excluded from the obligation to
Tetradecanoic acid is a saturated straight-chain C14-fatty acid,
which is present in bovine milk, breast milk as well as palm kernel oil,
coconut oil and butterfat.
In the UK and in several other countries, “the Department of
Health have set dietary reference values for fatty acids and recommend
that total fatty acid intake should average 30 % of total dietary energy
including alcohol (DoH, 1991). The available data demonstrate the low
toxicity of fatty acids and their salts, which is consistent with the
long history of safe use in foods for both fatty acids and glycerides.
Several of the fatty acids are Generally Recognised as Safe (GRAS) by
the U.S. Food and Drug Administration (US FDA). Substances that are
listed as GRAS include: stearic acid; oleic acid and sodium palmitate.
Stearic acid is also included by the Council of Europe (1974), at a
level of 4000 ppm, in the list of artificial flavouring substances that
may be added to foodstuffs without hazard to public health” (HERA, 2002).
“In 1974, the WHO set an unlimited ADI for the salts of myristic
(C14), palmitic (C16) and stearic (C18) acids. They stated that
myristic, palmitic and stearic acid and their salts are normal products
of the metabolism of fats and their metabolic fate is well established.
Provided the contribution of the cations does not add excessively to the
normal body load there is no need to consider the use of these
substances in any different light to that of dietary fatty acids (WHO,
1974; JECFA, 1986)” (HERA, 2002).
Based on the results of repeated dose toxicity studies with fatty
acids as described above, the conduct of any further toxicity studies
with repeated exposure in animals would not contribute any new
information and is therefore not considered to be required.
Since no repeated dose toxicity study is available specifically
for zinc ditetradecanoate, information on the individual constituents
zinc and tetradecanoic acid will be used for the hazard assessment and
when applicable for the risk characterisation of zinc ditetradecanoate.
Naturally occurring fatty acids are generally not considered to
represent a hazard to humans, which is reflected in their exclusion from
REACH registration requirements (cf REACH Annex V (Regulation (EC) No
987/2008)). Since the naturally occurring fatty acid tetradecanoic acid
(aka Myristic acid) is void of any human health hazard potential, zinc
is considered as the toxicological driver for the DNEL derivation.
Hence, the DNEL for zinc ditetradecanoate will be derived based on the
toxicological information for zinc. In case of zinc in zinc
ditetradecanoate, the NOAEL of 0.83 mg/kg bw/day (human data) will be
In relevant and reliable repeated dose toxicity studies as well as
human data for bothentities formed upon dissolution of zinc
ditetradecanoate, namely zinc and tetradecanoate, there were no
toxicological findings reported that would justify a classification for
specific target organ toxicity with repeated exposure. Hence, no
classification for zinc ditetradecanoate as STOT-RE is required.
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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