Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.