Registration Dossier
Registration Dossier
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EC number: 946-565-5 | 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:
- To be completed
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Test item: REACH substance = freeze-dried commercial product
- Analytical purity: 97.2%
- Purity test date: 08 March 2017
- Lot:bacth No.: WI6G16X07 after drying
- Expiration date of the lot/batch: 16 July 2018
- Appearance: Off-white to yellow crystals
- Storage: At room temperature - Key result
- Medium:
- n-octanol
- Solubility:
- 587 g/L
- Test substance stable:
- yes
- Conclusions:
- The solubility in n-octanol of the test item was 587 g/L.
- Executive summary:
The solubility in n-octanol of the test item (= REACH substance) was determined in a GLP-compliant study performed in accordance with standards equivalent or similar to EC A.8 method and OECD Guideline No. 105, using the flask method. The solubility in n-octanol of the test item was 587 g/L.
Reference
Preliminary test
The content of test item dissolved in the n-octanol sample was 138 g/L.
Main study
The results for the samples taken at 24, 48 and 72 hours are given in the table below.
Stirring time |
Analyzed concentration |
Mean |
Maximum difference |
|
|
|
|
24 |
580 |
587 |
2.3 |
|
|
|
|
48 |
743 |
|
|
|
|
|
|
72 |
594 |
|
|
|
|
|
|
The 48-hour measurement was significantly higher than the 24- and 72- hour measurements (maximum difference > 15%). According to the guidelines, the octanol solubility of the test item was given as the mean value of the 24- and 72-hour measurements, i.e. 587 g/L. No test item was detected in the pretreated samples from the blank octanol mixture.
Description of key information
The solubility in n-octanol of the test item (= REACH substance) was determined in a GLP-compliant study performed in accordance with standards equivalent or similar to EC A.8 method and OECD Guideline No. 105, using the flask method. The solubility in n-octanol of the test item was 587 g/L.
Key value for chemical safety assessment
- Solubility in organic solvents at 20°C:
- 587 g/L
Additional information
The solubility in n-octanol of the test item was determined in one GLP-compliant study performed in accordance with standard methods, without deviations. The study is considered as reliable (Klimisch 1) and is selected as a key study for the endpoint.
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.
