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EC number: 203-929-1
CAS number: 112-03-8
Based on the results from the in vivo irritation study, C18 TMAC is considered to be corrosive to skin as well as eyes.
A study was conducted to determine the skin
irritation / corrosion of the test substance, C18 TMAC (79.8% active)
according to OECD Guideline 404 and EU Method B.4, in compliance with
GLP. A paste containing 0.5 g of the test substance (purity of 79.8%)
with 0.3 mL isotonic saline was applied under semi-occlusive patches to
the clipped dorsal area of four rabbits. One animal was exposed for 4 h
and three animals were exposed for 3 min. The test sites were examined
for evidence of primary irritation and scored according to Draize
method. No signs of irritation were observed during the whole
observation period after exposure to 3 min. However, a 4 h exposure
resulted in slight to well defined erythema and a slight oedema, visible
30-60 min up to 22 days after removal of the plaster. Between one and
seven days after application, slight oedema was noted. During the
observation period, the treated skin area was sporadically dry, rough,
indurated, encrusted, chapped and discoloured. Twenty-two days after
application, pink coloured new skin and a scar was noted. Under the
study conditions, the test substance was found to be corrosive to rabbit
skin (Kreiling, 1996).
accordance with Annex VII, Section 8.2, Column 2, eye irritation
studydoes not need to be conducted because the substance is classified
as corrosive to the skin.
on the results of thein vivoskin irritation study, the test
substance warrants a corrosive, ‘Skin Corr. 1C; H314: Causes severe skin
burns and eye damage’ as well as serious eye damage, ‘Eye dam. 1; H31:
Causes serious eye damage’ classification according to the EU CLP
criteria (Regulation EC 1272/2008). Labelling for this endpoint is
covered by the above classifications for skin effects.
regard to respiratory tract irritation, although C18 TMAC is a very
corrosive substance, its low vapour pressure prohibits the occurrence of
respiratory irritation by vapour. Further, the classification of
corrosive is already considered to implicitly cover the potential of
RTI; therefore, an additional Cat.3 is considered to be superfluous
(Guidance CLP Ch. 18.104.22.168).
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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