Pentaerythritol

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study was conducted in accordance with OECD test guidelines, however no claim of GLP compliance was made, and a number of deviations from the guideline were recorded. The demands in the guideline regarding sterility and temperature variation (50 ± 0.5 °C) are not met (the heating cabinet manual states that the temperature is within ±0.4°C, however not checked), but considered to be of little significance to the result. The product was considered hydrolytically stable and if the result from the study would have shown that the product was hydrolytically instable we would have let a GLP certified laboratory run a further tests.

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

no

GLP compliance:

not specified

Remarks:

The demands in the guideline regarding sterility and temperature variation (50 ± 0.5 °C) are not met (heating cabinet manual states that the temperature is within ±0.4°C, however not checked), but considered to be of little significance to the result.

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material:
- Water solubility: Completely soluble at 20°C.

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent/transformation products: Samples were analysed after 5 days storage, for the parent compounds.
- Sampling method: Samples were allowed to reach room temperature then injected onto HPLC without dilution.

Buffers:

- pH: 4±0.01 (20°C)
- Composition of buffer: citric acid/sodium hydroxide/hydrogen chloride

- pH: 7±0.01 (20°C)
- Composition of buffer: di-sodium hydrogen phosphate/potassium di-hydrogen phosphate

- pH: 9±0.01 (20°C)
- Composition of buffer: boric acid/potassium chloride/sodium hydrogen

Duration:

5 d

pH:

4

Temp.:

50 °C

Duration:

5 d

pH:

7

Temp.:

50 °C

Duration:

5 d

pH:

9

Temp.:

50 °C

Number of replicates:

Duplicate measurements at each pH.

Positive controls:

no

Negative controls:

no

Preliminary study:

Pentaerythritol was shown to be hydrolytically stable during the preliminary test (conducted at a temperature of 50°C), and was therefore determined to be stable to hydrolysis.

Transformation products:

not measured

Remarks on result:

hydrolytically stable based on preliminary test

Remarks on result:

hydrolytically stable based on preliminary test

% Change in content of components:

(Difference found between sample stored at -20°C and +50°C after 5 days)

Pentaerythritol:       

pH 4 - -0.6%, -2.4%

pH 7 - 0.7%, -5.6%

pH 9 - 2.8%, -5.5%

Validity criteria fulfilled:

not specified

Conclusions:

No sign of hydrolysis was seen under the conditions investigated.

Executive summary:

A hydrolysis study was conducted by Perstorp AB, to determine the hydrolysis in water at different pH values of the test substance Pentaerythritol. The study was conducted according to the OECD 111 test guideline.

Solutions of the test substance in aqueous buffers at pHs 4, 7 and 9 were stored in a heating cabinet at 50°C for five days. At the end of the storage period, the samples at 50°C were analysed with samples which had been stored at -20°C, and the difference calculated.

It was concluded that no sign of hydrolysis was seen under the conditions investigated.

Description of key information

The substance pentaerythritol is stable to hydrolysis i.e. the estimated half-life of the components is greater than one year under typical environmental conditions.