2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)

Justification for type of information:

For acute toxicity, in addition to a test via the oral route (Annex VII, point 8.5.1) point 8.5 of Annex VIII to Regulation (EC) No 1907/2006 provides a standard information requirement for substances other than gases by at least one additional route (inhalation or dermal) depending on the likely route of human exposure. Recent scientific analysis of available data from in vivo acute toxicity studies have shown that substances that are not toxic via the oral route may be expected with high certainty to be also non-toxic via the dermal route. Therefore, testing those substances via the dermal route does not provide essential information for their safety assessment. Point 8.5 of Annex VIII to Regulation (EC) No 1907/2006 should thus be amended to provide for the possibility to waive the dermal test for such substances.

Conclusions of the endpoints acute oral toxicity: irritation/corrosion and sensitization:
Acute oral toxicity: LD50 (rat, male/female) > 5000 mg/kg bw (OECD TG 401; GLP, RL1)
Skin irritation: not irritating in rabbits (OECD TG 404; GLP; RL1); 
Eye irritation: not irritating in rabbits (OECD TG 405; GLP; RL1)
Sensitization: Several studies are available to assess the sensitisation potential of Isotridecyl methacrylate. Overall, Isotridecyl methacrylate is not a sensitiser.