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EC number: 695-797-0
CAS number: 93601-86-6
In the first pre-screen test body weight
loss was noted for all animals. Since no irritation and no clinical
signs were noted (except for bald forepaws in one animal), toxicological
relevance of the body weight loss was doubted also since most of the
animals had starting body weights higher than normal. Therefore the
pre-screen test was extended with three concentrations.
In this second pre-screen test, the body
weight loss noted for some animals at 25 and 50% was not considered to
be toxicologically relevant as the body weight loss was very slight and
no other signs of systemic toxicity were noted. Redness was noted for
both animals at 50% on Day 5, and scabs were noted for both animals on
Day 6. No signs of systemic toxicity were observed in any of the animals
examined, and no irritation was noted for any other animal. White test
substance remnants were visible on the ears of all animals on Days 1-3,
which did not prevent scoring of the ears. Scabbing was seen for two
animals at 50% on Day 6. Variations in ear thickness during the
observation period remained within the acceptable range (i.e. less than
the maximum of 25% from Day 1 pre-dose values). Based on these results,
the highest test substance concentration selected for the main study was
a 50% concentration
(highest technically possible concentration for a solid).
LLNA skin sensitisation study was performed according to OECD 429 and
according to GLP principles with the substance. Reliable positive and
negative controls were included. Based on the results of pre-screen
tests, three experimental groups of five female CBA/J mice were treated
with test substance concentrations of 10, 25 or 50% w/w on three
consecutive days, by open application on the ears. Five vehicle control
animals were similarly treated, but with vehicle alone
irritation of the ears was observed in any of the animals examined. The
auricular lymph nodes of four animals at 50% appeared larger in size as
compared to the other animals. This increase in size did not show a
clear relation to the DPM/animal values. No macroscopic abnormalities of
the surrounding area were noted in any of the animals.
Mean DPM/animal values for the experimental
groups treated with test substance concentrations 10, 25 and 50% were
410, 410 and 722 DPM, respectively. The mean DPM/animal value for the
vehicle control group was 367 DPM. Only four animals of the control
group were available for DPM measurements as one animal died during
3H-methyl thymidine injection procedure. Variability in measured DPM
values was within the expected variation for this type of study. The SI
values calculated for the substance concentrations 10, 25 and 50% were
1.1, 1.1 and 2.0, respectively. Based
on these data, the substance is considered not be a skin sensitiser, as
the SI was shown to be < 3 when tested up to and including 50%.
The substance does not need to be classified as skin sensitiser
according to GHS and CLP.
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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