Condensation products of Dihydrofuran-2,5-dione, mono-alkenyl derivs. with polyethylene amine and acetic anhydride

Solubility in organic solvents / fat solubility

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

solubility in organic solvents / fat solubility

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

February 6, 1997 -May 14, 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Restriction due to the fact that the study was conducted on read-across substance.

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

yes

Medium:

standard fat

Solubility:

1 155 other: g/kg

Temp.:

30 °C

Remarks on result:

other: Temerature range of 30°C to 50°C

Details on results:

See Table 2 (attached). Since the preliminary studies determined that the test substance was miscible in standard fat, a concentration of
approximately 120% was prepared and analyzed in the definitive study. The mean of the eight replicate samples is 1155 g/kg ± 34.5 (g of test substance per kg of fat). ..... The relative standard deviation is 2.99%. There is a small but statistically significant difference between Group I (30° C) and Group II (50° C) results. This is likely due to random analytical error. Because of the nature of the test substance in fat, the analytical column had to be regenerated after every four samples. The solubility of HCB in NATEC Standard Fat Lot 32 is 9.73+/-1.20. The solubility of HCB in NATEC Standard Fat Lot 33 is 7.89 g/kg ± 0.306. These values are similar to those cited in the OECD guidelines (11.4 g/kg).

Conclusions:

The results indicated that the test substance was completely miscible in the standard fat.

Executive summary:

The study was conducted to determine the solubility of the test substance in a standard fat. The test compared eight samples treated between 3 and 24 hours over a temperature range of 30°C to 50°C. The samples were analyzed via duplicate injections, using normal phase HPLC. The results were calculated as a mean concentration of the eight samples. The results were converted to grams of test substance per kilogram of standard fat by using the density measurements. The results indicated that the test substance was completely miscible in the standard fat. The mean of the eight replicate samples was 1155 g/kg ± 34.5 (g of test substance per kg of fat).The relative standard deviation was 2.99%. The result on the analogue material was considered to be appropriate for the Registration material.

Reference 2

Endpoint:

solubility in organic solvents / fat solubility

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Key result

Medium:

standard fat

Solubility:

ca. 1 155 other: g/kg

Temp.:

30 °C

Description of key information

A GLP study conducted in accordance with the OECD 116, the test substance was completely miscible in the standard fat (1155 g/kg ± 34.5 ). 

Key value for chemical safety assessment

Solubility in mg/100g standard fat:

115 500

At the temperature of:

20 °C

Additional information

A GLP compliant study conducted in accordance with the OECD 116 guideline, reported that the test substance was completely miscible in the standard fat (1155 g/kg ± 34.5). The result on the analogue material was considered to be appropriate for the Registration material.