Registration Dossier
Registration Dossier
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EC number: 242-560-0 | CAS number: 18765-38-3
Endpoint summary
Administrative data
Description of key information
In an in vivo skin irritation study (Hüls, 1992a)
tetrakis(2-butoxyethyl) orthosilicate was found to be irritating to
skin. The study was conducted according to an appropriate guideline and
in compliance with GLP.
In an in vivo eye irritation study (Hüls, 1992b) tetrakis(2-butoxyethyl)
orthosilicate was found not to be irritating. The study was conducted
according to an appropriate guideline and in compliance with GLP.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an in vivo skin irritation study conducted according to OECD 404 and in compliance with GLP (Hüls, 1992a), three male White Russian rabbits were exposed to tetrakis(2-butoxyethyl)orthosilicate under semiocclusive conditions for four hours. All three animals had moderate to severe erythema and oedema up to 24 hours after patch removal. After 72 hours, in addition to moderate to severe irritation, the skin was also dry and hardened, and shed after 6-8 days. At 6 days erythema and oedema were no longer recorded. By 10 days, all skin reactions had reversed. Based on these results tetrakis(2-butoxyethyl) orthosilicate was considered to be irritating to skin.
In an in vivo eye irritation study conducted according to OECD 405 and in compliance with GLP (Hüls, 1992b), three male White Russian rabbits had tetrakis(2-butoxyethyl)orthosilicate instilled into one eye, the other eye served as a control. Sixty minutes after exposure two of the rabbits had conjunctival chemosis (grade 1) and all three had conjuctival erythema (grade 1 and 2), which had reversed by 24 hours. There were no other effects on the eye. It was concluded that the test substance was not irritating to the eyes according to EU criteria.
Justification for classification or non-classification
Based on the available data tetrakis(2-butoxyethyl) orthosilicate requires classification for skin irritation as Category 2; H315: causes skin irritation, according to Regulation (EC) No 1272/2008.
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