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EC number: 217-983-9
CAS number: 2031-67-6
GPMT according to OECD TG 406: not sensitising
Signs of irritation were noted during the induction. Although
macroscopic examination showed grade 1 erythema/edema in 3 females 48 h
after challenge subsequent histopathological examinations did not reveal
any lesion of delayed hypersensitivity in the those animals. No
noticeable cutaneous abnormality was noted in the 20 guinea pigs
examined in the control group.
were chosen as key when the available study was of relevance and
sufficient quality for classification, labelling and risk assessment.
a key guinea pig maximisation study conducted in compliance with GLP and
according to OECD TG 406, triethoxy(methyl)silane was found to be a
non-sensitiser. Although macroscopic examination showed grade 1
erythema/edema in 3 females 48 h after challenge subsequent
histopathological examinations did not reveal any lesion of delayed
hypersensitivity in those animals.
sensitisation index was therefore calculated to be 15% for the test
group following challenge and rechallenge. A group of ten male and ten
female guinea pigs was dosed with multiple intradermal injections on day
0 following a topical application on day 7 in order to investigate
sensitisation potential of triethoxy(methyl)silane. The topical
induction consisted of a 48 hour occluded dermal exposure to 0.5 ml of
the test substance in a 50% (v/v) solution in sterile codex liquid
paraffin. Eleven days after topical induction, challenge dosing for
detection of sensitisation was performed. For challenge dosing, an
essentially non-irritating concentration (10% (v/v)) of the test
material was applied under occlusion for 24 hours. The test material
vehicle, sterile codex liquid paraffin, was also found to be
non-sensitising under the conditions of this study (Hazelton
France , 1992d).
available data on skin sensitisation of the registered substance do not
meet the criteria for classification according to Regulation 1272/2008
and are therefore conclusive but not sufficient for classification.
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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