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EC number: 619-217-2
CAS number: 96487-85-3
An acute oral toxicity study with Norethyl in rats (acute toxic lass
method) was performed according to OECD/EC test guidelines and GLP
principles. Norethyl was administered by oral gavage to two subsequent
groups of three female Wistar rats at 2000 mg/kg body weight. No
mortality occurred. Hunched posture, piloerection and/or ptosis were
noted for all animals on Day 1. The body weight gain shown by the
animals over the study period was considered to be similar to that
expected for normal untreated animals of the same age and strain. No
abnormalities were found at macroscopic post mortem examination of the
animals. The oral LD50 value of Norethyl in Wistar rats was established
to exceed 2000 mg/kg body weight. According to the OECD 423 test
guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg
body weight. Based on these results, Norethyl does not have to be
classified and has no obligatory labelling requirement for acute oral
toxicity according to the Globally Harmonized System of Classification
and Labelling of Chemicals (GHS) of the United Nations (2015) (including
all amendments) and Regulation (EC) No 1272/2008 on classification,
labelling and packaging of items and mixtures (including all amendments).
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