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EC number: 446-990-1
CAS number: -
According to eye and skin irritation studies performed (OECD 404 and 405), the test item is not irritating to eye and skin.
The product LCA01006 was applied, as supplied, at the dose of 0.5mL,
under semi-occlusive dressing during 4 hours on an undamaged skin area
of 3 rabbits, according to an experimental protocol established from the
O.E.C.D. guideline (n° 404 dated July.17th,1992) and the method B.4 of
the directive 92/69/E.E.C. dated December 29th,1992.
No cutaneous reactions (erythema and oedema) were observed in any animal
whatever the examination time.
The results obtained, in these experimental conditions, enabled to
conclude that the test product LCA01006, according to the scales of
interpretation retained : - is non irritant to skin (PSi = 0) according
to the classification established in the Journal Officiel de la
République Française dated February 21st, 1982, - and, must not be
classified, according to the criteria for classification, packaging and
labelling of dangerous substances in compliance with the E.E.C.
Directives 67/548 and 93/21.
The product LCA01006 was instilled, as supplied, into the eye of three
New Zealand rabbits at the dose of 0.1 ml, according to the experimental
protocol established on the basis of the official method as defined in
the O.E.C.D. guideline n° 405 dated February 24th, 1987 and the test
method B.5 of the directive 92/69/E.E.C. dated December 29th, 1992.
The ocular reactions observed during the study remained slight and only
recorded at the conjunctivae level: redness 1 hour after the test
product instillation and totally reversible between the 3rd and the 4th
day of the test, associated with a slight chemosis in the 3 animals on
examination time 1 hour only.
In conclusion, the result obtained, enable to conclude that the test
- is slightly irritant for the eye (Max. O.I = 9.3) according to the
classification established in the Journal Officiel de la République
Française dated July 10th, 1992.
- must not be classified according to the criteria for the
classification, packaging and labelling of dangerous substances in
compliance with the E.E.C. Directive n° 67/548 and 93/21.
Justification for selection of skin irritation / corrosion endpoint:
According to an OECD test n°404, the substance is not irritating to
Justification for selection of eye irritation endpoint:
According to an OECD test n°405, the substance is not significantly
irritating to the eyes.
The test item is not irritating to eye and skin according to the CLP
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