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EC number: 425-220-8 | CAS number: 5945-33-5
Subacute NOAEL (rat): 1000mg/kg bw (Method B7 of directive 92/69/EEC; GLP)
The repeated oral dose toxicity of (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No. 5945-33-5) has been evaluated in 3 studies. In the first guideline subacute study, the substance was administered in the diet (dissolved in acetone) for 28 days (high dose groups: 1862mg/kg bw to ten male rats and 1968mg/kg bw to ten female rats). No signs of toxicity were observed.
The study chosen as the key study was conducted in accordance with Method B7 of directive 92/69/EEC and GLP. The substance was administered by gavage (in Polyethylene glycol 400) up to a maximum dose of 1000mg/kg bw in 10 male and 10 female rats for 28 days. In addition, two recovery groups, each of five males and five females, were treated with the high dose (1000 mg/kg/day) or vehicle alone for 28 consecutive days and then maintained without treatment for a further 14 days. No toxicity was evident (clinical changes, laboratory findings or organ changes). NOEL and NOAEL values of 1000mg/kg bw were assigned and a NOAEL of 1000mg/kg bw will be used as the key value for repeated dose oral toxicity.
Based on the available information in the dossier, the substance(1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No.5945-33-5) does not need to be classified as specific target organ toxicity (repeated) when considering the criteria outlined in Annex I of 1272/2008/EC.
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