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Administrative data

Key value for chemical safety assessment

Additional information

there is no mutagenicity assay performed with ZK 5686 (gestonorone), results of studies with a different ester of gestonorone (gestonorone caproate, ZK 5623) are regarded as representative as most likely ester cleavage occurs in vivo after administration

ZK 5623 (gestonorone caproate) did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA98, TA 100, TA 102, TA 1535 and TA1537) up to the highest tested concentration of 2.5 mg/plate (at which precipitates of test compound were observed) in the absence or presence of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats). [Schering AG, Report 3024, 1978-02-01]

Results of a dominant-lethal test in male mice with ZK 5623 did not indicate a mutagenic potential up to the highest tested dose of 200 mg/kg. [Schering AG, Report No. 3038, 1978-02-16]

Results of a dominant-lethal test in male rats with ZK 5623 showed decrased insemination and pregnancy indices at the high dose of 60 mg/kg. No other findings were described even at the high dose indicating that ZK 5623 does not have a dominant lethal effect. [Schering AG, Report 4057, 1979-11-15]

A mutagenic potential of ZK 5623 is also not expected based on negative results with other steroid hormones in mutagenicity assays.

Short description of key information:
There are no data with ZK 5686; read across with results of studies with gestonorone caproate (ZK 5623):

Gene mutation (bacterial reverse mutation assay / Ames test, non-GLP): negative with and without metablic activation
[Schering AG, Report 3024, 1978-02-01]

Dominat-lethal test (Mouse, male, non-GLP, subcutaneous, doses: 0/ 2/ 20/ 200 mg/kg, twice weekly, 7 weeks): negative
[Schering AG, Report No. 3038, 1978-02-16]

Dominat-lethal test (Rats, male, non-GLP, Doses: 0/ 2/ 20/ 60, twice weekly, 10 week): negative
[Schering AG, Report 4057, 1979-11-15]

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Not classified according to German legislation (TRGS-905) for gestagens. No mutagenicity expected.

Based on the results no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).