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EC number: 231-901-9
CAS number: 7778-39-4
In an acute dermal toxicity study performed
similarly to OECD guideline 402 and in compliance with GLP, groups of
New Zealand White rabbits (5/sex/dose) received a single dermal dose of
Desiccant L-10 at 200, 400, 800, 1600 and 3200 mg/kg bw on clipped area
of the trunk representing at least 10% of the total body surface area.
The application was occluded and exposure was for 24 hours. Animals were
then observed for mortality, clinical signs and bodyweights for 14 days
and were all macroscopically necropsied after death or sacrifice.
Mortalities were 0, 20 and 100% at 200-800,
1600 and 3200 mg/kg bw, respectively. All animals exhibited minimal
weight changes (± 0.2 mg/kg bw) except one male at 800 mg/kg bw (48%
weight loss). Severe abnormalities (hypoactivity, irregular breathing,
nasal discharge and decreased food consumption) were observed in animals
which died within 2 days. Clinical signs noted in surviving animals were
decreased food consumption, occasional occurrences of soft or mucoidal
stool and other isolated abnormalities. Most surviving animals were free
of abnormalities at study termination. Necropsy of the dead animals
revealed dermal lesions and abnormalities in the lungs and
gastrointestinal tract associated with postmortem autolytic changes,
antemortem stress and/or normal physiologic variation. Necropsy of the
surviving animals revealed no abnormalities. The acute dermal LD50 for
males and females were determined to be 1750 (944-2556) and 2300 mg/kg
bw, respectively. The combined dermal LD50 was calculated to be 2000
(1583-2417) mg/kg bw.
Dermal reactions noted in several animals
were necrosis followed by eschar formation and exfoliation.
Under the test conditions, the acute dermal
LD50 for Desiccant L-10 was calculated to be 2000 (1583-2417) mg/kg bw
in rabbits therefore it is classified as ‘R21 Harmful in contact with
skin’ according to the Annex VI of the Directive 67/548/EEC and
‘Category 4’ according to the CLP Regulation (EC) No. 1272 /2008.
This study is acceptable and satisifes the guideline
requirement for an acute dermal toxicity study (OECD 402).
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