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EC number: 221-338-7 | CAS number: 3069-40-7
In an acute oral toxicity study that was comparable to the now deleted OECD Test Guideline 401, but not to GLP (reliability score 2) the LD50 was at least 3500 mg/kg bw for male and female rats (ASTA Pharma AG, 1988).
In an inhalation study conducted to OECD Test Guideline 403 and to GLP (reliability score 1) the LC50 for 4-hour aerosol exposure to trimethoxy(octyl)silane was 7.5 and 1.9 g/m3 for males and females, respectively (TNO-CIVO, 1990).
Table 1 Mortality data
Table 2 Clinical signs of toxicity
The 50% accumulation point for all four distributions was around 2.4 µm. All distributions showed a similar pattern: about 60% (exposure to 6.2 g/m3) to 89% (exposure to 0.9 g/m3) of the particles were between 1.8 and 3.4 µm in diameter.
Table 1 Summary of concentrations and mortality data
In an acute oral toxicity study that was comparable to the now deleted OECD Test Guideline 401, but not to GLP (reliability score 2) the LD50 was at least 3500 mg/kg bw for male and female rats (ASTA Pharma AG, 1988). Following a dose of 3236 mg/kg bw there were coordination disturbances, piloerection, chromodacryorrhea, increased salivation and red nasal discharge. Following a dose of 4752 mg/kg bw there was additionally decreased muscle tone, loss of righting reflexes and increased diuresis. Individually, tremor, vocalisation on handling, lacrimation, opacity of the cornea and green discoloured urine occurred in addition. The development of toxic effects was protracted, with coordination disturbances detected after two hours, and all other symptoms from days 2-5. All symptoms disappeared by day 21 of the observation period.
In an inhalation study conducted to OECD Test Guideline 403 and to GLP (reliability score 1) the LC50 for 4-hour aerosol exposure to trimethoxy(octyl)silane was 7.5 and 1.9 g/m3 for males and females, respectively (TNO-CIVO, 1990). The combined LC50 was 3.9 g/m3. Clinical effects included reduced body weights, slow breathing, piloerection and signs of ataxia. There were no dermal data. However, the skin irritation study (ASTA Pharma AG, 1987a) did not reveal any systemic effects.
In the acute inhalation study (TNO-CIVO, 1990), the test atmospheres contained a mixture of vapour and aerosol, but based on the vapour pressure of the substance (2.1 Pa at 25°C), it is likely that the majority of the test atmosphere was aerosol.
Based on the available data, trimethoxy(octyl)silane does not need to be classified for acute toxicity (lethality) following a single oral exposure according to Regulation (EC) No 1272/2008.
Following oral exposure there were clinical signs (e.g. coordination disturbances, loss of muscle tone, ataxia). However these were observed only at dose levels far in excess of the maximum dose used according to current guideline standards therefore no classification is applied for this endpoint.
For the inhalation route, it is not considered appropriate to classify for acute toxicity as the observed effects are due to exposure to aerosol droplets rather than to systemic availability of the test substance. Inhalation of aerosol droplets is not a relevant route of exposure for this substance.
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