Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Only limited toxicological data are available on D6N, however, a substantial amount of toxicological information exists on the similar substance delta-6-nandrolone acetate (CAS No 2590-41-2, EC No 425-330-6).  Throughout the dossier, the read-across substance is referred to as dienone or D6N-acetate. The justification for the read-across to D6N is described below.

 

Read-across from delta-6-nandrolone acetate to delta-6-nandrolone

D6N and D6N-acetate are close structural analogues which share common functional groups. The only structural difference relates to the substitution of the hydroxyl group in the C17 position of D6N with an acetyl-group in D6N-acetate. 

 

As shown in the attached document, the physico-chemical properties of both substances are similar. The structural and physico-chemical similarities also mean that the toxicokinetics of D6N and D6N-acetate in humans and animals will be analogous with it being expected that the esterase mediated cleavage of the acetyl moiety ultimately generates the registration substance, D6N.

The available data indicate that both the mammalian toxicology and environmental fate of D6N and D6N-acetate are also equivalent.

 

Therefore, the read-across of the following endpoints are sufficiently justified for the 1-10 tonne (Annex VII) registration of D6N:

 

  • Acute Toxicity-Dermal
  • Skin Irritation/Corrosion
  • Eye Irritation
  • Skin Sensitisation
  • Genotoxicity