Registration Dossier

Administrative data

Description of key information

LD50 cut-off value was considered to be 1000 mg/kg body weight

Key value for chemical safety assessment

Additional information

The oral LD50 value of delta-6-nandrolone (D6N) in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. According to the OECD 423 test guideline, the D50 cut-off value was considered to be 1000 mg/kg body weight.

 

For the read-across substance, D6N-acetate, the acute oral discriminating dose for the read-across substance is 500 mg/kg. Based on these results, the acetate is more acutely toxic via the oral route than the registration substance, therefore adding an additional level of conservatism to the read-across justification.

 

Justification for classification or non-classification

Based on these results and according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011), delta 6-nandrolone should be classified as: harmful if swallowed (Category 4) for acute toxicity by the oral route. - according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, delta-6-nandrolone should be classified as Category 4 and should be labeled as H302: Harmful if swallowed.

Based on data from the read-across substance (LD50>2000mg/kg), D6N is not classified for dermal acute toxicity.