Santicizer P1400

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Novembre 2015 to 05 May 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

A discussion and report on the read across strategy is provided as an attachment in Section 13 of the dossier.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: Procedure was compatible with Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 and OCSPP Method 835.2120.

GLP compliance:

yes

Specific details on test material used for the study:

Lot 0900
Purity 98.8%

Analytical monitoring:

yes

Details on sampling:

The sample solutions were taken from the waterbath at various times and the pH of each solution recorded.

Buffers:

The test system used sterile buffer solutions at pH’s 4, 7 and 9.

Buffer solution (pH 4): Citric acid 0.006 mol dm-3, Sodium chloride 0.004mol dm-3, Sodium hydroxide 0.007mol dm-3
Buffer solution (pH 7): Disodium hydrogen orthophosphate (anhydrous) 0.003mol dm-3, Potassium dihydrogen orthophosphate 0.002 mol dm-3, Sodium chloride 0.002 mol dm-3
Buffer solution (pH 9):Disodium tetraborate 0.001mol dm-3, Sodium chloride 0.002mol dm-3

Details on test conditions:

Testing was undertaken at pH 4, with solutions being maintained at 50.0 ± 0.5 °C, 60.0 ± 0.5 °C and 70.0 ± 0.5 °C for periods of 264, 192 and 144 hours respectively. Testing was also undertaken at pH 7, with solutions being maintained at 50.0 ± 0.5 °C, 60.0 ± 0.5 °C and 70.0 ± 0.5 °C for periods of 504, 432 and 120 hours respectively. Testing was also undertaken at pH 9, with solutions being maintained at 50.0 ± 0.5 °C, 60.0 ± 0.5 °C and 70.0 ± 0.5 °C for periods of 192, 168 and 52 hours respectively.

Duration:

264 h

pH:

4

Temp.:

50 °C

Duration:

192 h

pH:

4

Temp.:

60 °C

Duration:

144 h

pH:

4

Temp.:

70 °C

Duration:

504 h

pH:

7

Temp.:

50 °C

Duration:

432 h

pH:

7

Temp.:

60 °C

Duration:

120 h

pH:

7

Temp.:

70 °C

Duration:

192 h

pH:

9

Temp.:

50 °C

Duration:

168 h

pH:

9

Temp.:

60

Duration:

52 h

pH:

9

Temp.:

70 °C

Number of replicates:

2

Positive controls:

no

Transformation products:

yes

No.:

#1

No.:

#2

Key result

pH:

4

Temp.:

25 °C

Hydrolysis rate constant:

0 s-1

DT50:

155 d

Key result

pH:

7

Temp.:

25 °C

Hydrolysis rate constant:

0 s-1

DT50:

74 d

Key result

pH:

9

Temp.:

25 °C

Hydrolysis rate constant:

0 s-1

DT50:

154 d

Validity criteria fulfilled:

yes

Conclusions:

The estimated rate constants and half-lives at 25°C for the test item were; pH 4: estimated rate constant: 5.19x10-8 s-1 at 25°C, Estimated half life at 25°C: 155 days. pH 7: estimated rate constant: 1.08x10-7 s-1 at 25°C, Estimated half life at 25°C: 74 days. pH 9: estimated rate constant: 5.22x10-8 s-1 at 25°C, Estimated half life at 25°C: 154 days.

Executive summary:

The testing was conducted according to a procedure which is compatible with Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 and OCSPP Method 835.2120. The results of the study found that the estimated rate constants and half-lives at 25°C for the test item were; pH 4: estimated rate constant: 5.19x10-8 s-1 at 25°C, Estimated half life at 25°C: 155 days. pH 7: estimated rate constant: 1.08x10-7 s-1 at 25°C, Estimated half life at 25°C: 74 days. pH 9: estimated rate constant: 5.22x10-8 s-1 at 25°C, Estimated half life at 25°C: 154 days.  

Description of key information

The testing was conducted according to a procedure which is compatible with Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 and OCSPP Method 835.2120. The results of the study found that the estimated rate constants and half-lives at 25°C for the test item were; pH 4: estimated rate constant: 5.19x10-8 s-1 at 25°C, Estimated half life at 25 °C: 155 days. pH 7: estimated rate constant: 1.08x10-7 s-1 at 25°C, Estimated half life at 25 °C: 74 days. pH 9: estimated rate constant: 5.22x10-8 s-1 at 25°C, Estimated half life at 25 °C: 154 days.