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Environmental fate & pathways

Hydrolysis

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
other: expert statement based on structural evaluation
Adequacy of study:
supporting study
Study period:
07 Nov 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
not specified
Principles of method if other than guideline:
No data
GLP compliance:
no
Remarks:
expert statement
Analytical monitoring:
no
Remarks:
expert statement, thus no analytical monitoring required.
Duration:
5 d
pH:
4
Temp.:
50 °C
Duration:
5 d
pH:
7
Temp.:
50 °C
Duration:
5 d
pH:
9
Temp.:
50 °C
Preliminary study:
No hydrolytic degradation was observed within 5 days at pH 4, 7 and 9 at 50 °C.
Transformation products:
no
Key result
pH:
7
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
other: based on the structural analogous compound (21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione)
pH:
4
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
other: based on the structural analogous compound (21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione)
pH:
9
Temp.:
25 °C
DT50:
> 1 yr
Remarks on result:
other: based on the structural analogous compound (21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione)
Details on results:
Based on the result of the structural analogous compound (21-Hydroxy-16 alpha-methyl-4-pregnene- 3,20-dione (CAS 39987-86-5), Fluocortolon can be considered as hydrolytically stable (t1/2 > 1 year at 25 °C) at ph 4,7,and 9.

No validity criteria are applied as the evaluation of the hydrolytic behaviour is done based on the structural elucidation of the molecule.

Validity criteria fulfilled:
not applicable
Conclusions:
Fluocortolon can be considered to be hydrolytically stable at pH 4, 7 and 9 at 25 °C.
Executive summary:

The hydrolytic behaviour of Flucortolone was not determined experimentally but derived from the experimental result of 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione. This substance was not susceptible to hydrolytic degradation with DT50 values > 1 yr at pH4, 7 and 9 at 25 °C. Since both substances are structurally similar it is justified that Fluocortolone does not degrade by hydrolysis either. In addition Fluocortolone does not contain functional groups allowing hydrolytic degradation.

Description of key information

The substance 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 a substance 21-Hydroxy-16 alpha-methyl-4-pregnene- 3,20-dione (CAS 39987-86-5) which is structurally similar to the test substance. The analogous compound was found to be hydrolytically stable in the pH region 4 -9 and 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"