Registration Dossier
Registration Dossier
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EC number: 613-915-0 | CAS number: 66233-43-0
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- other: Expert Statement
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: expert statement
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- 1.3 yr
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- 5.8 d
- Conclusions:
- Delta-9(11)-Fluocortolon-Valerat is structurally similar to Fluocortolon-21-Valerat except the latter has an additional hydroxyl group in position 11 and a double bond less. Thus similar behavior regarding hydrolysis is expected.
The rate of hydrolysis was determined at pH 4, 7 and 9 and the rate constants and half-lives at 25 °C were in the range between 5.8 days (pH 9) and higher than one year (pH 4, 7). According to the criterion in EC guideline C.7 Fluocortolon-21-Valerat is considered to be stable at pH 4 and 7 at 25 °C.
On the basis of the structural similarity hydrolytic stability is to be expected at pH 4 - 7 for delta-9(11)-Fluocortolon-Valerat. Above pH 7 hydrolytic degradation is increasing with pH. - Executive summary:
Delta-9(11)-Fluocortolon-Valerat is structurally similar to Fluocortolon-21-Valerat except the latter has an additional hydroxyl group in position 11 and a double bond less. Thus similar behavior regarding hydrolysis is expected.
The rate of hydrolysis was determined at pH 4, 7 and 9 and the rate constants and half-lives at 25 °C were in the range between 5.8 days (pH 9) and higher than one year (pH 4, 7). According to the criterion in EC guideline C.7 Fluocortolon-21-Valerat is considered to be stable at pH 4 and 7 at 25 °C.
On the basis of the structural similarity hydrolytic stability is to be expected at pH 4 - 7 for delta-9(11)-Fluocortolon-Valerat. Above pH 7 hydrolytic degradation is increasing with pH.
Reference
Description of key information
The rate of hydrolysis was evaluated in an expert statement based on the results from the analogous substance Fluocortolon-21 -Valerat. Hydrolytic behaviour was determined at pH 4, 7 and 9 according to EU method C.7. Half-lives at pH 4 and 7 > 1 year and at pH 9 = 5.8 days at 25 °C resulted. On the basis of the structural similarity hydrolytic stability is to be expected at pH 4-7 for the present substance. Above pH 7 hydrolytic degradation increasing with pH will occur.
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °C
Additional information
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