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EC number: 944-461-4
CAS number: -
Skin, rabbit (OECD 404): not irritating
Eye, rabbit (OECD 405): not irritating
1: individual eye irritation scores
mean of 24 + 48 + 72 h
A skin irritation study was performed with Reaction mass of
according to OECD guideline 404 and under GLP conditions (Sanders,
2010). 0.5 g of the test substance moistened with 0.5 mL water was
applied to the clipped skin of 3 male New Zealand White rabbits and held
in place by a semi-occlusive dressing for 4 hours. The skin irritation
effects were scored 0, 1, 24, 48 and 72 hours after patch removal. No
erythema or edema was observed in any animal at any time point. The mean
erythema and edema scores (over 24, 48 and 72 hours) were 0, 0 and 0,
for each animal, respectively. Based on the results of the conducted
study, the test substance is not considered to be irritating to the skin.
The potential eye irritating effect of Reaction mass of
was assessed in an eye irritation study performed according to OECD
guideline 405 and under GLP conditions (Sanders, 2010). 0.1 mL of the
test substance was instilled into one eye of 3 male New Zealand White
rabbits. The eye irritation effects were scored 1, 24, 48 and 72 hours
after instillation. 3/3 animals had moderate conjunctivae and chemosis
(score 2) at the 1-hour reading time point. At the 24-hour reading time
point the conjunctivae and chemosis readings were less severe (score 1),
and all eye irritation effects had cleared within 48 hours after test
substance administration. No animals showed any irritation effects on
the cornea and iris at any reading time point. The mean conjunctivae
score (over 24, 48 and 72 hours) was 0.33 for all 3 animals. The mean
chemosis score (over 24, 48 and 72 hours) was 0.33 for all 3 animals.
Based on the results of the study, the test substance is not considered
to be irritating to the eyes.
The available data on skin and eye irritation do not meet the
classification criteria according to Regulation (EC) 1272/2008 and are
therefore conclusive but not sufficient for classification.
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