Registration Dossier

Administrative data

Description of key information

The key study for skin sensitisation for tri(isopropyl)silyl acrylate was conducted in accordance with OECD test guideline 429 and in compliance with GLP. In this local lymph node assay the test material was positive for skin sensitisation (SI≥3 at 100%) with an EC3 value of 69.4% (RCC, 2004d). The key study is the only available study for this endpoint.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The key study is the only available study for the substance, tri(isopropyl)silyl acrylate.

The key skin sensitisation study tested the registered substance, TIPSA, in a local lymph node assay, conducted to OECD test guideline 429 and in compliance with GLP (RCC, 2004d).

Test material (25 µl of 25, 50 or 100%

in acetone/olive oil) was topically applied to the entire dorsal surface of each ear lobe of groups of 4 female mice, daily for 3 consecutive days. 5 days after the first topical application, 3H-methyl thymidine was injected intravenously into a tail vein and, approximately 5 hours later, mice were sacrificed, draining auricular lymph nodes excised, pooled per group and the incorporation of 3H-methyl thymidine measured.

All treated animals survived the study period and no clinical signs of toxicity were observed. The stimulation indices for the 25, 50 and 100% treatment groups were 2.2, 1.8 and 4.9 respectively.

The registered substance was found to be a skin sensitizer (SI3 at 100%) with an EC3 value of 69.4% under the conditions of the test.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information for tri(isopropyl)silyl acrylate, classification is required for sensitisation, Skin Sensitiser Category 1B, H317: 'May cause an allergenic skin reaction', in accordance with Regulation (EC) No 1272/2008.