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EC number: 436-230-7
CAS number: -
- Skin/Eye: Corrosive
irritation/corrosion studies have been carried out on the registered
THPC-urea-amine. The studies submitted are for a closely related
substance ITC 826. Read-across is considered justified since the only
differences between ITC 826 and the current product are in amine carbon
chain length (C16 -18for ITC 826 and C14for the
Skin irritation/ corrosion:
study was available for this endpoint and considered as the key study
(Lees, 1996). This study was conducted according to OECD guideline 404
and in compliance with GLP (Rel. 2). The test substance was ITC 826
Concentrate. Following an in vitro pre-screen, the test sites were
covered with an occlusive dressing for 3 minutes or 1 hour. No
irritation was seen at the 3-minute application site.
the basis of an in vitro pre-screen, a single New Zealand White
rabbit was exposed to 0.5 mL of a water dilution of ITC 826 (around 69%
Active Ingredient – AI) for a three minute and one hour exposure. The
animal was assessed for up to three days for any signs of
irritation was seen at the three minute application site. At the one
hour application site, very slight to severe erythema and slight to
severe oedema was observed. Additional observations included blanching,
suspected necrosis, application sites raised and wrinkling of the
application site. As a result of suspected necrosis at day three,
confirmed by a histopathological examination, the test was terminated.
Based on these results, ITC 826 is considered as corrosive following a
one hour exposure.
analogy with ITC 826, THPC-urea-amine is considered as corrosive to skin.
Eye irritation/ corrosion:
826 was assessed for corrosive properties to the eye using the rabbit
isolated eye assay. The test substance caused significant corneal
swelling following a 10 second exposure. A maximal swelling of 29.4% was
observed at 5 hours post dosing. Minimal opacity was seen in both eyes
at 2, 3, 4 and 5 hours post dosing. ITC 826 was considered likely to be
a severe ocular irritantin vivo.
vivo study is available for this end-point. However, the study is
scientifically unjustified considering animal welfare as THPC-urea-amine
is classified as skin corrosive (column 2 of REACH Annex VIII). Based on
the results of the skin irritation study (Lees, 1996) performed on ITC
826, THPC-urea-amine is classified as "causes severe skin
burns and eye damage" according to EU criteria.
selection of skin irritation / corrosion endpoint:
No study performed on THPC-urea-amine was available. However, one
study performed on ITC 826 (analogous) with good reliability was
available (Kr. 2).
Justification for selection of eye irritation endpoint:
No study performed on THPC-urea-amine was available. However, one in
vitro study performed on ITC 826 (analogous) with good reliability was
available (Kr. 2). No in vivo study conducted due to skin corrosivity.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
a 1 hour dermal exposure of the skin of one rabbit to ITC 826, evidence
of necrosis was noted after 3 days and the experiment terminated (Lees
1996, Rel. 1). By analogy with ITC 826, THPC-urea-amine is classified
into Category1B, H314 (causes severe skin burns and eye damage) and into
category 1, H318 (Causes
serious eye damage)
according to the CLP
(1272/2008) and as corrosive (C, R34) according to the Directive 67/548/EEC.
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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