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EC number: 413-110-2
CAS number: 135861-56-2
Maximum concentration not causing irritating effects in preliminary
Signs of irritation during induction: well defined erythema was noted at
the intradermal induction sites of all test group animals at the 24 and
48 -hour observations.
Very slight erythema was noted at the intradermal induction sites of all
control group animals at the 24 -hour observation and in four control
group animals at the 48 -hour observation.
Very slight to well-defined erythema was noted at the induction sites of
all test group animals at the 1 -hour observation with very slight
erythema at the induction sites of nine test group animals at the 24
Bleeding from the intradermal industion sites was noted in five test
group animals at the 1 -hour observation. Residual test material was
noted in all test group animals. Bleeding from the intradermal induction
sites was noted in one control group animal at the 1 -hour observation.
No signs of erythema or oedema were noted at the treatement sites of
control group animals at the 1 and 24 -hour observations.
Evidence of sensitisation of each challenge concentration:
Number of animals showing evidence of sensitisation at each challenge
Other observations: bodyweight gains of animals in the test group,
between day 0 and day 24, were comparable to those in hte control group.
There are two available studies to determine if the substance is skin
sensitising or not. Both of them were done following GLP.
In a study performed in 1993 according to OECD Guideline 406, no
positive reaction was observed.
In a study performed in 1998 according to EU Test Method B6 (Guinea pig
maximisation test), no positive reaction was observed.
The available experimental test data are
reliable and suitable for classification purposes under Regulation
1272/2008. The values obtained have been compared to criteria set up in
the Annex I of the Regulation (section 3.4). As a result the substance
is not considered to be classified as skin sensitising under Regulation
(EC) No. 1272/2008.
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