Registration Dossier
Registration Dossier
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EC number: 238-830-2 | CAS number: 14765-30-1
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:
- June 06, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Name (as stated in the report): Freskomenthe
Batch: VE00426966
Expiration date: February 19, 2018 - Key result
- Water solubility:
- 577 mg/L
- Conc. based on:
- test mat.
- Incubation duration:
- 5 d
- Temp.:
- 20 °C
- pH:
- 6.8
- Details on results:
- The method showed acceptable results for linearity, accuracy, precision and specificity according to SANCO 3029/99 rev.4 (2000) and fulfilled all study plan requirements.
- Conclusions:
- The solubility of the test item was determined at 20 ± 0.5 °C to be 577 mg/L (pH 6.8).
- Executive summary:
The water solubility of FRESKOMENTHE (batch: VE00426966) was determined according to OECD guideline 105 (1995) and Council Regulation (EC) No. 260/2014, Method A.6 from 2016-05-30 to 2016-06-06 at Noack Laboratorien, 31157 Sarstedt, Germany.
The solubility of the test item FRESKOMENTHE was determined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C.
The analytical method (HPLC-DAD, external standard) for the determination of the test item FRESKOMENTHE was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.
The water solubility of FRESKOMENTHE was determined to be:
577 mg/L (20 °C, pH 6.8)
Reference
Description of key information
The water solubility of FRESKOMENTHE (batch: VE00426966) was determined according to OECD guideline 105 (1995) and Council Regulation (EC) No. 260/2014, Method A.6 from 2016-05-30 to 2016-06-06 at Noack Laboratorien, 31157 Sarstedt, Germany.
The solubility of the test item FRESKOMENTHE was determined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C.
The analytical method (HPLC-DAD, external standard) for the determination of the test item FRESKOMENTHE was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.
The water solubility of FRESKOMENTHE was determined to be:
577 mg/L (20 °C, pH 6.8)
Key value for chemical safety assessment
- Water solubility:
- 577 mg/L
- at the temperature of:
- 20 °C
Additional information
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