Registration Dossier
Registration Dossier
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EC number: 214-154-3 | CAS number: 1100-88-5
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 7th, 2017 to January 30th, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- - Analytical purity: >=99.5%
- Purity test date: 02 March 2017
- Lot/batch No.: 180739
- Expiration date of the lot/batch: Not specified
- Appearance: Off-white powder
- Storage: At room temperature - Key result
- Water solubility:
- 74.3 g/L
- Conc. based on:
- test mat.
- Incubation duration:
- >= 24 - <= 72 h
- Temp.:
- 20 °C
- pH:
- >= 3.9 - <= 4
- Conclusions:
- The water solubility of the test item at 20°C was 74.3 g/L.
- Executive summary:
The water solubility of the test item was determined in a GLP-compliant study performed in accordance with EC Guideline A.6 and OECD Guideline No. 105, using the flask method. The water solubility of the test item at 20°C was 74.3 g/L.
Reference
Preliminary Test
The content of test item dissolved in the water sample after three centrifugation steps was 75.0 g/L.
Main Study
The results for the samples taken at 24, 48 and 72 hours are given in the table below.
Stirring time [hours] |
Analyzed concentration [g/L] |
Mean [g/L] |
Maximum difference [%] |
pH |
24 48 72 |
73.7 / 74.9 74.9 / 75.3 74.5 / 72.7 |
74.3 |
3.5
|
4.0 / 4.0 3.9 / 3.9 3.9 / 4.0 |
The maximum difference of the concentrations determined in the 24, 48 and 72 hour test samples was ≤ 15%. Based on this, the water solubility of the test item is given as the mean value of the analyzed concentrations. No test item was detected in the pretreated sample from the blank water mixture.
Description of key information
The water solubility of the test item was determined in a GLP-compliant study performed in accordance with EC Guideline A.6 and OECD Guideline No. 105, using the flask method. The water solubility of the test item at 20°C was 74.3 g/L.
Key value for chemical safety assessment
- Water solubility:
- 74.3 g/L
- at the temperature of:
- 20 °C
Additional information
The water solubility of the test item was determined in a 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.
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