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EC number: 208-901-2
CAS number: 546-46-3
The key study for skin irritation is read across from trisodium citrate (CAS 68-04-2) in which the test substance not irritating to rabbit skin according to EU criteria (Roche, 1995; rel 1). For eye irritation, positive findings for trizinc dicitrate were observed in an in vitro test according to OECD 492 while no effect was observed in a second in vitro test (BCOP, OECD 437).
The test item trizinc dicitrate was applied to a
three-dimensional human cornea tissue model in duplicate for an exposure
time of 6 h.
The solid test item was applied to each tissue. After treatment with the
test item, the relative absorbance values were reduced to 4.7 %.
This value is well below the threshold for eye irritation potential (≤
There were no available data for the irritation potential of trizinc
dicitrate to the skin. While it is evident from the data on trisodium
citrate that the skin and eye irritation attributable to the citrate is
low, the irritation potential of zinc needed to be investigated. EU Risk
Assessment reports on other zinc compounds (peer reviewed and reliable)
were used to assess the zinc irritation potential in addition to the
available information on the citrate.
Zinc sulphate, zinc distearate and zinc chloride which are analogous in
their physico chemical properties to those of trizinc dicitrate, were
considered as suitable for read across to trizinc dicitrate as
supporting studies for irritation potential of zinc. The best available
information for read across was derived from zinc sulphate (CAS
7733-02-0); the EU Risk Assessment Report (RAR) on zinc sulphate reports
no irritation of the test substance to the skin. However, zinc sulphate
is found irritating to the eye and labelled as R41 (risk of serious
damage to eyes).
Furthermore, it should be taken into account that zinc compounds have
been used for over decades in a variety of pharmaceutical and cosmetic
products (some of them even in dermatological preparations against skin
irritation) without any reported effects suggesting irritant properties.
Based on the available information, classification or labelling for eye
irritation (Category 2) is required for trizinc dicitrate, in accordance
with current EU Directive 67/548/EEC or Regulation 1272/2008.
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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