Registration Dossier
Registration Dossier
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EC number: 406-860-7 | CAS number: -
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:
- 16 October 1990 to 23 October 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method A.7
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Product designation: Monoazo Yellow BG 3247
Identification: FAT 40400/A BG 3247/TV 6 - Medium:
- standard fat
- Remarks:
- fat simulant HB 307, batch 27
- Solubility:
- < 0.05 mg/100 g solvent
- Temp.:
- 37 °C
- Test substance stable:
- yes
- Conclusions:
- The fat solubility of FAT 40400/A is lower than 0.05 mg/100 g fat at 37 °C.
- Executive summary:
In a GLP-compliant study, performed according to EU method A.7, the fat solubility of the test substance was determined. The content of the test substance in fat simulant HB 307 was determined by spectrophotometry after extraction with water. The average fat solubility was determined from eight experiments to be lower than 0.05 mg/100 g fat at 37 °C.
Reference
Flasks
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
Weight of test substance in mg | 1.47 | 1.76 | 1.82 | 1.99 | 1.52 | 1.98 | 1.49 | 1.54 |
weight of fat in g | 25 | 25 | 25 | 25 | 25 | 25 | 25 | 25 |
Temperatures of agitation (°C) | 30 /37 | 30 /37 | 50 /37 | 50 /37 | ||||
Agitation duration | 1h /1h | 1h /1h | 1h /1h | 1h /1h | ||||
Equilibration duration at 37 °C | 1 h | 1 h | 1 h | 1 h | ||||
S' | <0.05 | <0.05 | <0.05 | <0.05 | <0.05 | <0.05 | <0.05 | <0.05 |
S | <0.05 | <0.05 | <0.05 | <0.05 | <0.05 | <0.05 | <0.05 | <0.05 |
mean value | <0.05 mg/100 g fat | |||||||
standard deviation | - mg/100 g fat | |||||||
Fat solubility at 37 °C = <0.05 mg/100 g fat | ||||||||
S' = concentration of test substance in mg/100 g fat solution.
S = concentration of test substance in mg/100 g fat.
Description of key information
In a GLP-compliant study, performed according to EU method A.7, the fat solubility of the test substance was determined (Ciba-Geigy 1990). The content of the test substance in fat simulant HB 307 was determined by spectrophotometry after extraction with water. The average fat solubility was determined from eight experiments to be lower than 0.05 mg/100 g fat at 37 °C.
Key value for chemical safety assessment
- Solubility in mg/100g standard fat:
- 0.05
- At the temperature of:
- 37 °C
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
