Registration Dossier

Administrative data

Description of key information

The key study for acute oral toxicity study in rats was conducted according to OECD test guideline 423 and in compliance with GLP. The LD50 identified for tri(isopropyl)silyl acrylate was >2000 mg/kg bw (RCC 2004a).

The key study for acute dermal toxicity study in rats, was conducted according to OECD test guideline 402 and in compliance with GLP. The LD50 identified for tri(isopropyl)silyl acrylate was >2000 mg/kg bw (RCC 2004b).

In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and dermal routes are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The key data are the only available studies for tri(isopropyl)silyl acrylate.

The key study for acute oral toxicity (RCC, 2004a) was conducted to OECD test guideline 423 and in compliance with GLP. Female rats were treated by oral gavage with a dose of 2000 mg/kg bw in PEG 300 and observed for 14 days. All of the animals survived until the end of the study but slight to moderate ataxia was observed at the 2-hour observation and up to test day 2 in one animal and slight ataxia in four further animals at 5 hours post-dosing. The gross pathology revealed no macroscopic findings.

The key study for acute dermal toxicity (RCC 2004b) was conducted to OECD test guideline 402 and in compliance with GLP. In this study, a 24-hour semi-occlusive, dermal application of test material was applied to rats. The animals were observed over a period of 14 days, and the LD50 identified was >2000 mg/kg bw (RCC 2004b). The clinical signs included very slight erythema observed in all male and female animals on test day 2 which persisted in all males up to test day 4 and in two females up to test day 6 and 7 respectively. Slight crusts were noted on one male on test day 5, in another male from test day 5 to 8 and on one female on test day 8. No macroscopic findings observed at necropsy.


Justification for classification or non-classification

Based on available data on the acute toxicity of the registered substance, tri(isopropyl)silyl acrylate, no classification is required in accordance with Regulation (EC) No 1272/2008.