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EC number: 268-074-9
CAS number: 68002-61-9
This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl trimethyl ammonium chloride and SDA Reporting Number: 11-045-00.
Based on the results from the in vivo irritation study, C16 -18 and C18 -unsatd. TMAC is considered to be corrosive to skin as well as eyes.
For result tables, kindly refer to the
attached background material section of the IUCLID.
study was conducted to determine the skin irritation potential of the
test substance, C16 -18 and C18 -unsatd. TMAC (50% active) in rabbits,
according to a method similar to OECD Guideline 204. Six rabbits (both
sexes) were treated with 0.5 mL of undiluted test substance (50% active
ingredient) in an occlusive patch fixed with adhesive tape and wrapped
with an impervious material, for 4 h. Observations were made at 4 h, 48
h and 10 days post-exposure. If the test substance appeared to be
corrosive after 4 h, another study was conducted with a 1 h exposure
period under similar test conditions. The Draize scoring criteria was
used for evaluating the corrosion potential. At 4 h, very slight to
well-defined erythema, very slight ischemia and very slight oedema were
observed, with an average irritation score of 4/8. At 48 h, there was
well-defined to moderate erythema, very slight to slight ischemia and
very slight or slight oedema and the average irritation score was 5.4/8.
After 10 days, slight to distinct incrustation and decreased hair growth
was observed. After an exposure period of 1 h, very slight erythema was
observed with an average irritation score of 0.85/8. After 48 h, there
was very slight to moderate erythema and very slight or slight oedema
and the average irritation score was 1.25/8. No skin effects were
observed after 10 days. Under the study conditions, the undiluted test
substance (50% active ingredient) was corrosive after 4 h of occlusive
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 the in vivo skin 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
regard to respiratory tract irritation, although C16-18 and C18-unsatd.
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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