Cerium doped lutetium yttrium orthosilicate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)

Justification for type of information:

Referring to Column 2 of REACH Annex VII (standard information requirements for substances manufactured or imported in quantities of 1 tons per year or more) of Regulation (EC) No 1907/2006, studies on skin irritation/corrosion do not need to be conducted if an acute study by the dermal route does not indicate skin irritation up to the limit dose level of 2,000 mg/kg body weight. According to the results of the acute dermal toxicity limit test performed with lutetium-yttrium oxyorthosilicate, cerium doped performed in accordance with OECD Guidelines for Testing of Chemicals (Section 4, No. 402, "Acute Dermal Toxicity"), single dermal application of lutetium-yttrium oxyorthosilicate, cerium doped to rats at a dose of 2,000 mg/kg body weight was not associated with significant signs of skin irritation or corrosion (see section 7.2.3 of the IUCLID dossier). Based on these findings conducting of a study to determine the skin irritation potential of lutetium-yttrium oxyorthosilicate, cerium doped is considered as scientifically not necessary under Regulation (EC) No 1907/2006 (REACH).