Tetrahydro-4-methyl-2H-pyran

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018-08-27 to 2018-09-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Version / remarks:

None

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

-Concentrations: Samples of all concerntration were taken at the initiation and after 5 days

Buffers:

Preparation of Buffer solution

pH 4.0: The solution was prepared by mixing 4.5mL of 1 mol/L sodium hydroxide solution and 50mL of 0.5 mol/L potassium dihydrogen citrate solution and then filling up to 500mL with purified water, and then adjusting the pH 4.0 with 1 mol/L hydrochloric acid.

pH 7.0: The solution was prepared by mixing 14.8mL of 1 mol/L sodium hydroxide solution and 50mL of 0.5 mol/L potassium dihydrogen phosphate solution and then filling up to 500mL with purified water, and then adjusting the pH 7.0 with 1 mol/L hydrochloric acid

pH 9.0: The solution was prepared by mixing 10.7ml of 1 mol/L sodium hydroxide solution and 50mL of 0.5 mol/L potassium chloride solution and 0.5 mol/L boric acid solution, and then filling up to 500mL with purified water, and then adjusting the pH 9.0 with 1 mol/L hydrochloric acid

The buffer solution was filtered with a sterile filter after the preparation.

Preliminary study:

The test item is hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0.

Transformation products:

no

% Recovery:

ca. 101

pH:

9

Duration:

ca. 5 d

% Recovery:

ca. 96.1

pH:

7

Duration:

ca. 5 d

% Recovery:

ca. 98.3

pH:

4

Duration:

ca. 5 d

pH:

9

Remarks on result:

hydrolytically stable based on preliminary test

pH:

7

Remarks on result:

hydrolytically stable based on preliminary test

pH:

4

Remarks on result:

hydrolytically stable based on preliminary test

Details on results:

The test item is hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0.

Results with reference substance:

No adverse effect on the reliability of this test were noted. The test item is hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0.

Table 1: The pH of test solutions at initiations are shown as follows

Test solution	pH of test solution ( at initiation)
pH4.0	4.0
pH7.0	7.0
pH9.0	9.0

 

 

Table 2: The Residual Percentage of the test item

Test solution	Concentration (mg/L)		Residual percentage
	At Initiation	After 5days		Average
pH4.0	421	412	97.8	98.3
		417	98.9
pH7.0	430	415	96.6	96.1
		411	95.6
pH9.0	407	413	101	101
		413	101

 

 

Validity criteria fulfilled:

yes

Conclusions:

The residual percentage of test item at each pH was larger than 90%. Therefore, the test item is hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0.

Description of key information

The residual percentage of test item at each pH  was larger than 90%. Therefore, the test item is hydrolytically stable at pH 4.0, pH 7.0 and pH 9.0.