Bis(4-methylbenzoyl)peroxide

Solubility in organic solvents / fat solubility

Link to relevant study record(s)

Reference

Endpoint:

solubility in organic solvents / fat solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 30, 1991 till October 3, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted GLP study, according to OECD and EEEC guidelines, purity mentioned.

Qualifier:

according to guideline

Guideline:

OECD Guideline 116 (Fat Solubility of Solid and Liquid Substances)

Version / remarks:

Adopted May 12, 1981.

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EEC-Directive 84/449 EEC, Annex V, Part A, Methods for the determination of physico-chemical properties, A.7: "Fat solubility". EEC Publication no. L251, September 1984.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Medium:

standard fat

Solubility:

> 630 - < 730 mg/100 g solvent

Temp.:

37 °C

Remarks on result:

other: standard fat HB 307

Test substance stable:

not determined

Representative HPLC-chromatograms of a standard solution of DI-(4-METHYLBENZOYL)-PEROXID (INTEROX-PMBP), a pretreated fat sample and a pretreated blank fat sample are shown in Figures 1, 2 and 3, respectively in the attachment.

The chromatograms of the pretreated blank fat sample did not show any peak with the same retention as the test substance.

The fat solubility estimated from the preliminary test was 7.5 g/L (mean value of all measurements). No significant differences were observed between the concentrations analysed after the second and third centrifugation step.

The results of the individual measurements of the main study are summarized in Table 1.

 

Table 1 Results of the fat solubility of

DI-(4-METHYLBENZOYL)-PEROXID (INTEROX-PMBP) at 37.0 ± 0.5°C.

 

stirring time [hours]	Concentrations analysed^0[g/kg]
	Group I^1	Group I I^2
3	6.39	6.46
3	6.76	7.09
24	6.38	6.76
24	6.99	7.24

⁰Results of duplicate analysis.

¹After undersaturation.

²After oversaturation.

 

No significant differences were observed in the results from the 3 and 24 hours stirring period as well as in the results from the under- and oversaturation group after both the 3 and 24 hours stirring period. Hence, the fat solubility was calculated as the mean value of all measurements.

According to the guidelines (OECD, EEC), the test was considered to be valid.

In conclusion, the fat solubility of

DI-(4-METHYLBENZOYL)-PEROXID (INTEROX-PMBP) in standard fat HB 307 was determined to be 6.8 ± 0.5 g/kg , i.e. 680 ± 50mg/100g, at 37.0 ± 0.5°C.

Conclusions:

The fat solubility of bis(4-methylbenzoyl)peroxide in standard fat HB 307 is 680 ± 50mg/100g, at 37.0 ± 0.5°C.

Executive summary:

The determination of the fat solubility was based on OECD Guideline No.116 "fat solubility of solid and liquid substances" (1981) and EEC Directive A.7 "fat solubility" (1984).

The fat solubility of bis(4-methylbenzoyl)peroxide in standard fat HB 307 is 680 ± 50mg/100g, at 37.0 ± 0.5°C.

Description of key information

The fat solubility of bis(4-methylbenzoyl)peroxide in standard fat HB 307 is 680 ± 50mg/100g, at 37.0 ± 0.5°C.

Key value for chemical safety assessment

Solubility in mg/100g standard fat:

680

At the temperature of:

37 °C