Norethisterone

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Conclusions:

Norethisteron does not contain functional groups which are susceptible to hydrolytic degradation. Hydrolytic stability is thus to be expected.

Executive summary:

Norethisteron does not contain functional groups which are susceptible to hydrolytic degradation. Hydrolytic stability is thus to be expected. This notion is experimentally supported by the results of a hydrolysis study with Levonorgestrel (CAS. 797-63 -7) which is structurally similar to Norethisteron.

Description of key information

Norethisterone can be classified as hydrolytically stable at pH 5, 7 and 9 (25 °C).

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

25 °C

Additional information

"Should read: > 1 year at 25 °C"

Norethisterone does not contain any functional group which is susceptible to hydrolytic degradation. Thus hydrolytic stability is to be expected. This is experimentally supported by the results of a hydrolysis study with Levonorgestrel (CAS 797-63-7), which differs in an ethyl- instead of the methyl group in position 13 and was found to be hydrolytically stable in the pH region 5 to 9 (at 25 °C).The same behaviour is to be expected for norethisterone.