Registration Dossier

Administrative data

Description of key information

Acute oral toxicity according to OECD 401: LD50: 2120 mg/kg bw
Dose range finding study for Micronucleus test in mice: lethal oral dose: 1800 mg/kg bw, highest sublethal dose: 1300 mg/kg bw
In a repeated dose study (dietary administration) a substance with similar chemical structure (2-Nitroanisole) revealed methemoglobinemia at higer dose levels. (IARC MONOGRAPHS VOLUME 65)

Key value for chemical safety assessment

Additional information

LD50 values of available studies are 2120 mg/kg bw for rats and around 1800 mg/kg bw for mice after oral application. Data of substances with similar structure support the suspicion that 1,4-dimethoxy-2-nitrobenzene might have a methemoglobin forming potential. With respect to Met-Hb forming substances rats are known to react with lower sensitivity than humans. Based on that the human acute oral toxicity dose is estimated to be higher than 300 but not higher than 2000 mg/kg bw.

Justification for classification or non-classification

LD50 estimates of >300 and <=2000 mg/kg bw for oral ingestion meet criteria for classification according to DIRECTIVE 67/548/EEC (DSD-DPD) or REGULATION (EC) No 1272/2008 (GHS/CLP). Since Met-Hb formation in humans is suspected and since systemic availability for all three exposure routs is not unlikely a precautionary classification as R20/21/22 or Cat 4, H302/H312/H332 irrespective of the routs tested is warranted.