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EC number: 252-161-3
CAS number: 34708-08-2
key study for the sensitisation of triethoxy(3-thiocyanatopropyl)silane
(CAS No. 34708-08-2, EC No. 252-161-3) found the test material to be not
sensitising in a study conducted according OECD Test Guideline 406
(non-LLNA, Buehler test) and in compliance with GLP (Harlan Laboratories
Ltd., 2012, reliability score 1). An LLNA study was not performed
because the test method is not considered to be suitable for substances
that contain silicon.
the ECHA Endpoint Specific guidance (Chapter R.7a, version 6, July 2017)
existing data of good quality that were generated before 10 May 2017, or
for which the study was initiated before 10 May 2017, can be used to
address the skin sensitisation endpoint. The OECD 406 Test Guideline
study for triethoxy(3-thiocyanatopropyl)silane was conducted in 2012 and
therefore additional testing for this endpoint is not required.
controls were assessed at the laboratory at least twice a year. During
2011 (prior to this experiment), the result from the positive control
study had resulted in allergic contact dermatitis in >15% of the test
animals when testing alpha-hexylcinnamaldehyde as a skin sensitiser.
Alpha-hexylcinnamaldehyde is recommended to use by the Commission
Regulation (EC) No 440/2008, B.6 and OECD 406 since it causes moderate
skin sensitisation in guinea pigs. No further details are provided.
of First Challenge:
animals of control group 1 and 18 of 20 animals of the test group did
not show any skin reactions after the first challenge with 15%
(weight/weight) test item in diglyme. Two animals of the test group
(animals no.16 and no. 19) showed discrete or patchy erythema at the
48-hour reading after the first challenge with 15% test item in diglyme.
One animal of control group 1 (animal no.12) and one animal of the test
group (animal no. 19) showed discrete or patchy erythema at the 48-hour
reading after the first challenge with 5% test item in diglyme and
another animal of the test group (animal no. 32) showed discrete or
patchy erythema at the 24-hour as well as at 48-hour reading after the
first challenge with 5% test item in diglyme.
of Second Challenge:
animal (animal no. 19) of the test group showed discrete or patchy
erythema at the 48-hour reading
after the challenge with 15% (weight/weight) test item in diglyme and
one animal of the test
group (animal no. 14) showed discrete or patchy erythema at the 24-hour
reading after the challenge
with 5% (weight/weight) test item in diglyme. No skin reactions occurred
in the control groups.
the key non-adjuvant sensitisation test, conducted according to OECD
Test Guideline 406 and in compliance with GLP (Harlan Laboratories Ltd.,
2012, reliability score 1), male guinea pigs (20 test item and 10
controls) were exposed to 5 of 15% of the test item and to diglyme,
respectively, under occlusive conditions for 6 hours. Induction was
conducted once a week for 3 weeks, with the first challenge two weeks
after the last induction dose. An incidence of 10% was observed for each
of the triethoxy(3-thiocyanatopropyl)silane concentrations of 5% and 15%
in diglyme in the first challenge. However, as different animals
responded, the overall incidence in this first challenge was 15%, which
is the threshold for sensitisers as defined by the OECD and EC
guidelines. Therefore, a second challenge was performed, again testing
the same concentrations of 5% and 15%. In this second challenge, an
incidence of 5% was observed for each of the tested concentrations of 5%
and 15% of test item in diglyme in the second challenge and the overall
incidence in this second challenge was 10%, which is below the 15%
threshold. Taking into account that one control animal also responded in
the first challenge and the incidence of the skin reactions decreased in
the second challenge, the observed skin reactions are attributed to a
slight irritation of the skin and not to a true sensitisation.
Therefore, the test item is considered not sensitising.
on the findings in a non-adjuvant sensitisation test in guinea pigs,
triethoxy(3-thiocyanatopropyl)silane does not require classification as
a skin sensitiser in accordance with Regulation (EC) No 1272/2008.
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