Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-03-08 till 2008-05-22
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 40840/A TE
- Substance type: colouring dye
- Physical state: solid, dark red powder
- Analytical purity: approx. 78.9% org. part (NA-salt), MC: 37.7%, Oligomers: 19.2%
- Purity test date:
- Lot/batch No.: ROE 358 BOP 01/07
- Expiration date of the lot/batch: June 30, 2012
- Storage condition of test material: At room temperature at about 20°C

Results and discussion

Water solubility
Water solubility:
74.098 g/L
Temp.:
20 °C
pH:
6.4
Details on results:
FAT 40840/A TE was not tested till full satuartion of the test solution

Any other information on results incl. tables

Results obtained for the Solubility of FAT 40840/A TE in Water

Initial of Weight test Item [g]  Water added [mL]  Measured concentration [mg/L]  Dilution factor  Solubility in water [mg/L] Mean 
 4.03 19  13.904  5000  69518.884  
 4.02  19  16.651  5000  83254.843  74097.537
4.03  19  13.904  5000  69518.884  

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The water solubility of FAT 40840/A TE was found to be 74.098 g/L at room temperature.
Executive summary:

This study was performed in accordance with EC method A.6 and the OECD Gu ideline 105. The substance FAT 40840/A TE was tested with a simpliefied flask method. The test substance was stirred at room temperature during 24 hours filtrated, diluted and analyzed with HPLC. The result of the preliminary test indicates, that FAT 40840/A TE is soluble in water. Therefore, it is not possible to prepare a saturated solution from the test item in water and a main test as described in the guidelines is not possible.

Due to the results in the preliminary test, the water solubility of FAT 40840/A TE was found to be 74.098 g/L at room temperature.