Registration Dossier
Registration Dossier
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EC number: 200-681-6 | CAS number: 68-22-4
Hydrolysis
Administrative data
Link to relevant study record(s)
- 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.
Reference
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.
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