Registration Dossier
Registration Dossier
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EC number: 223-564-1 | CAS number: 3962-66-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Toxicity to reproduction: other studies
Description of key information
No studies investigating toxicity on reproduction are available for delta-5 -norandrostendion. However, delta-5 -norandrostendion has a structural similarity to nandrolone, which is classified as anabolic steroid according to German legislation (TRGS-905).
There are internal data available on the interaction of delta-5 -norandrostendion and sex hormone receptors:
Internal data from transactivational assays also showed androgenic potential of delta-5 -norandrostendion at 10 nM [88% compared to 109% (nandrolone)] and 1 µM [30% compared to 65% (nandrolone)], which was lower, but in a similar range compared to nandrolone. Further, delta-5 -norandrostendion showed a low binding affinity towards the estrogen receptor, which was lower compared to nandrolone. The agonistic/antagonistic profile at the progesterone receptor of delta-5 -norandrostendion was comparable to the profile of nandrolone.
In addition, only the position of one double bond and a 17-keto group (delta-5 -norandrostendion) instead of a 17-hydroxy group (nandrolone) differs between both substances. But the isomerisation of this double bond from 5,10 -position to 4,5 -position, as well as the transformation to the 17-hydroxy group will easily occur in vivo. Therefore, a close effect relationship between delta-5 -norandrostendion and nandrolone has to be assumed in vivo.
Justification for classification or non-classification
There are no studies on the reproductive toxicity of delta-5 -norandrostendion available. However, delta-5 -norandrostendion showed slightly weaker but comparable androgenic potential in vitro as the structural similar nandrolone, which is classified according to German legislation (TRGS-905) for anabolic steroids as Repr. (F) Cat. 1A and Repr. (D) Cat. 1B. Further, delta-5 -norandrostendion can be transformed to nandrolone in vivo.
Based on in vitro hormone receptor binding data and a read across to nandrolone, delta-5 -norandrostendion is classified with category Repr. (F) Cat. 1A and Repr. (D) Cat. 1B according to Regulation (EC) 1272/2008 (CLP).
Additional information
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