Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Results and discussion

Transformation products:
not measured
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
25 °C
DT50:
> 8 760 h
pH:
7
Temp.:
25 °C
DT50:
> 8 760 h

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
According to the EEC Directive 92/69, Section C.7 it can be concluded, that the estimated
half-life time is higher than one year under representative environmental conditions (25”C).
Therefore, ucb 22060 was considered to be hydrolytically stable, and no further testing was
necessary.
Executive summary:

The hydrolysis determination of ucb 22060 at different pH values was based on the OECD Guideline No. 111, “Hydrolysis as a Function of pH”; adopted May 12, 1981 and on the EEC Directive 92/69, Section C.7, “Abiotic Degradation: Hydrolysis as a Function of pH”, L383 A, December 1992. The results of pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of ucb 22060 at 50°C. The degradation of ucb 22060 was less than 10 % after 5 days. The results are summarised in the table abov. pH Hydrolysis after 5 days, 50°C [%] 4.0