Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2014 - October 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
liquid
Details on test material:
- Name of test material (as cited in the expert statement): Folenox
- Chemical name: 4,4,8,8-Tetramethyloctahydro-4a,7-methanonaphtho[1,8a-b]oxirene (IUPAC)
- Empirical formula: C15H24O
- Structural formula: See IUCLID section 1
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Buffers:
Acetate buffer pH 4, 0.01 M
Phosphate buffer pH 7, 0.01 M
Borate buffer pH 9, 0.01 M
Duration of testopen allclose all
Duration:
0.33 h
pH:
4
Temp.:
20 °C
Initial conc. measured:
0.994 mg/L
Duration:
148.8 h
pH:
7
Temp.:
20 °C
Initial conc. measured:
1.46 mg/L
Duration:
23.53 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
1.54 mg/L
Duration:
5.67 h
pH:
7
Temp.:
60 °C
Initial conc. measured:
1.47 mg/L
Duration:
720 h
pH:
9
Temp.:
20 °C
Initial conc. measured:
1.42 mg/L
Duration:
221.27 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
1.85 mg/L

Results and discussion

Transformation products:
not measured
Dissipation half-life of parent compoundopen allclose all
pH:
4
Temp.:
20 °C
Half-life:
2.7 min
pH:
7
Temp.:
20 °C
Half-life:
38 h
pH:
9
Temp.:
20 °C
Half-life:
56 d
Details on results:
At pH7 and pH9, the half-life times at temperartures of 50 and 60 were also determined. See attached study report for details.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

The rate of hydrolysis of Folenox as a function of pH was determined at pH values normally found in the environment (pH 4 to 9). The results indicate that Folenox does undergo hydrolysis. Folenox undergoes faster hydrolysis in acidic conditions (pH 4), and slower hydrolysis in alkaline conditions (pH 9). The half-life times of the test substance at 20'C were determined to be 2.7 minutes (pH 4), 38 hours (pH 7) and 56 days (pH 9).