Registration Dossier
Registration Dossier
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EC number: 305-224-5 | CAS number: 94350-05-7 Substance obtained by acidic, alkaline, or enzymatic hydrolysis of rice bran composed primarily of amino acids, peptides, and proteins. It may contain impurities consisting chiefly of carbohydrates and lipids along with smaller quantities of miscellaneous organic substances of biological origin.
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The study was conducted according to an internationally recognised method. No deviation was reported. Test substance is adequately specified. Therefore full validation applies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of method:
- flask method
Test material
- Reference substance name:
- Protein hydrolyzates, rice bran
- EC Number:
- 305-224-5
- EC Name:
- Protein hydrolyzates, rice bran
- Cas Number:
- 94350-05-7
- IUPAC Name:
- Protein hydrolyzates of Oryza Sativa
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: beige powder
- Storage: in a dark place at room temperature
- Batch : 16 208
- Manufacturing date: July 26th 2016
- Expiry date: July 26th 2018
Constituent 1
Results and discussion
Water solubility
- Key result
- Water solubility:
- ca. 716.1 g/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 2 368 g/L
- Temp.:
- 30 °C
- pH:
- ca. 6
- Remarks on result:
- other: The water solubility of NUTRIPEPTIDES® AT was determined as 716.1 g/L at 30 ± 0.5°C (pH=6). The conditions of the test were: - loading rate of 2368 ± 9 g/L - a water content of 7.0% w/w of Nutripeptides® AT (dry matter result obtained on the powder).
Applicant's summary and conclusion
- Conclusions:
- A non-GLP study using flask method according to OECD method 105 and EU. A.6. was conducted to determine the water solubility of the test item.
The water solubility of test item was determined as 716.1 g/L at 30 ± 0.5°C (pH=6).
The conditions of the test were:
- loading rate of 2368 ± 9 g/L
- a water content of 7.0% w/w of test item (dry matter result obtained on the powder). - Executive summary:
A non-GLP study using flask method according to OECD method 105 and EU. A.6. was conducted to determine the water solubility of test item.
The water solubility of test item was determined as 716.1 g/L at 30 ± 0.5°C (pH=6).
The conditions of the test were:
- loading rate of 2368 ± 9 g/L
- a water content of 7.0% w/w of test item (dry matter result obtained on the powder).
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