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EC number: 405-290-6 | CAS number: 12036-37-2
Solubility in organic solvents / fat solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- solubility in organic solvents / fat solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 October 1991 - 16 January 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 116 (Fat Solubility of Solid and Liquid Substances)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Method A.7
- Deviations:
- no
- GLP compliance:
- yes
- Medium:
- standard fat
- Solubility:
- 0.32 mg/100 g solvent
- Temp.:
- 37 °C
- Conclusions:
- The solubility of the test material in standard fat was determined to be 0.32 mg/100 g of fat at 37 °C.
- Executive summary:
The solubility of the test material in fat was determined in accordance with the standardised guidelines OECD 116 and EC Method A.7.
The solubility of the test material in HB 307 standard fat simulant was determined to be 0.32 mg/100 g of fat at 37 °C.
Reference
Table 1 Measurements of solubility in standard fat HB 307 at 37 °C
Sample Treatment |
Solute Concentration (mg/kg) after two periods at 37 °C |
|
2 Hours |
24 Hours |
|
Initially 72 hours at 30 °C (1 g test material in 22 g fat) |
3.8, 4.4 |
2.2, 3.7 |
Initially 72 hours at 50 °C (1 g test material in 22 g fat) |
1.5, 2.2 |
5.4, 2.2 |
Overall (pooled) mean = 3.2 ± 1.35* = 0.32 ± 0.135 mg/100 g fat (C. of V. = 43 %)
*the large standard deviation is attributed to the proximity of the measured concentrations to the limit of assay (1.5 mg/kg)
Description of key information
The solubility of the test material in standard fat simulant was determined to be 0.32 mg/100 g of fat at 37 °C.
Key value for chemical safety assessment
- Solubility in mg/100g standard fat:
- 0.32
- At the temperature of:
- 20 °C
Additional information
In the key study, the solubility of the test material in fat was determined in accordance with GLP and the standardised guidelines OECD 116 and EC Method A.7.
The solubility of the test material in HB 307 standard fat simulant was determined to be 0.32 mg/100 g of fat at 37 °C.
Supporting information is provided in the form of a second study that investigated the solubility of the test material in fat that was carried out in accordance with GLP and the standardised guideline EU Method A.7.
The solubility of the test material in HB 307 standard fat simulant was determined to be 0.823 mg/100 g of fat at 37 °C.
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