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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- and Guideline-Study with no or minor deficiencies.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 2-amino-5-fluorobenzoate
EC Number:
608-681-1
Cas Number:
319-24-4
Molecular formula:
C8 H8 F N O2
IUPAC Name:
methyl 2-amino-5-fluorobenzoate
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
The samples (filled in vials) were taken out of the water bath, cooled down to room temperature to slow down the hydrolysis and then analyzed by HPLC. The pH of each sample was measured in an aliquot of the solution.

Results and discussion

Preliminary study:
At pH 4 and 7 the observed degradation was below 10 % within 5 days. So no main test had to be conducted at this pH values.
At pH 9 the hydrolysis rate was found to be < 50 % (2.4 h) and > 10 % (5 d).
Transformation products:
not measured
Dissipation DT50 of parent compoundopen allclose all
pH:
9
Temp.:
50 °C
Hydrolysis rate constant:
0.025 h-1
DT50:
27.8 h
St. dev.:
-0.998
Type:
(pseudo-)first order (= half-life)
Remarks on result:
other: ln (c) = 5.74019 - 2.49643e-2 * t [h]
pH:
9
Temp.:
35 °C
Hydrolysis rate constant:
0.004 h-1
DT50:
157.3 h
St. dev.:
0.998
Type:
(pseudo-)first order (= half-life)
Remarks on result:
other: ln (c) = 4.4059 - 4.405862e-3 * t [h]
pH:
9
Temp.:
25 °C
Hydrolysis rate constant:
0.001 h-1
DT50:
550.9 h
St. dev.:
1
Type:
(pseudo-)first order (= half-life)
Remarks on result:
other: Extrapolated by linear regression

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The half-life of the test item at 25 °C is approx. 23 days (pH 9).