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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.
Studies were chosen as key when the available study was of relevance and sufficient quality for classification, labelling and risk assessment.
In 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.
The 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.
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