Registration Dossier
Registration Dossier
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EC number: 214-787-5 | CAS number: 1194-65-6
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:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of method:
- flask method
- Key result
- Water solubility:
- 20.5 mg/L
- Temp.:
- 298 K
- pH:
- 5
- Key result
- Water solubility:
- 21.2 mg/L
- Temp.:
- 298 K
- pH:
- 7
- Key result
- Water solubility:
- 21.9 mg/L
- Temp.:
- 298 K
- pH:
- 9
- Conclusions:
- Under the conditions of the test, the water solubility of the test material was determined to be 21.2 mg/L at pH 7 using the shake flask method.
- Executive summary:
In a non-GLP compliant water solubility study conducted in accordance with standardised guideline OECD 105, the water solubility of the test material was determined using the shake flask method. Under the conditions of the test, the water solubility of the test material was determined to be 21.2 mg/L at pH 7.
Reference
Table 1: Results
| Buffer solution pH | Solubility (mg/L) | |||||
| Flask 1 | Flask 2 | Flask 3 | Flask 4 | Average | Coefficient of variation (%) | |
| 5.0 | 2.03 | 2.05 | 2.05 | 2.08 | 2.05 | 1.0 |
| 7.0 | 2.10 | 2.12 | 2.14 | 2.12 | 2.12 | 0.8 |
| 9.0 | 2.17 | 2.19 | 2.19 | 2.22 | 2.19 | 0.9 |
Description of key information
The water solubility of the test material was determined to be 21.2 mg/L at pH 7 according to a study performed in line with OECD Guideline 105.
Key value for chemical safety assessment
- Water solubility:
- 21.2 mg/L
- at the temperature of:
- 298 K
Additional information
The key study (Berkel and Olthof, 1988) was performed in line with a standardised guideline, but not to GLP, with a sufficient level of detail to assess the quality of the presented data. The study was performed to a good standard and was assigned a reliability score of 2 using the principle for assessing data quality as set out in Klimisch (1997). This study was considered to be the key study as further information on the methodology and results were provided and the study was performed using three pH values.
The supporting study (Berkel et al., 1987) was performed in line with a standardised guideline, but not to GLP, with a sufficient level of detail to assess the quality of the presented data. The study was performed to a good standard and was assigned a reliability score of 2 using the principle for assessing data quality as set out in Klimisch (1997).
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