Perhydroimidazo[4,5-d]imidazole-2,5-dione

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

Justification for type of information:

In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.1.2 (as amended by Commission Regulation (EU) 2016/863) the acute dermal toxicity (OECD TG 402) study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. Available in vivo (OECD TG 423) acute oral toxicity and in vivo (OECD TG 409) 28 day repeated dose toxicity (28d RDT) indicates that the substance is not acutely toxic; the oral LD50 is >2000mg/kg bw and the oral 28d RDT NOEAL is >=1000mg/kg bw. No systemic toxicity in skin sensitisation or irritation studies provides a definitive conclusion on the classification can be made. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.