Registration Dossier
Registration Dossier
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EC number: 271-770-5 | CAS number: 68607-88-5 Substance obtained by acidic, alkaline, or enzymatic hydrolysis of soya 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.
Melting point / freezing point
Administrative data
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to an internationally recognised method, and under GLP. The substance is considered to be adequately characterised with its purity. Therefore full validation applies.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- boiling point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to an internationally recognised method, and under GLP. The test substance is adequately characterised. Therefore, full validation applies.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 103 (Boiling Point)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.2 (Boiling Temperature)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- differential scanning calorimetry
- Key result
- Atm. press.:
- >= 101 320 - <= 101 330 Pa
- Decomposition:
- yes
- Remarks:
- A black residue was observed after the experimentation, the powder inflated. No boiling point of the test item was recorded.
- Remarks on result:
- other: A black residue was observed after the experimentation, the powder inflated. No boiling point of the test item was recorded.
- Conclusions:
- No boiling point was recorded.
- Executive summary:
The determination of boiling point test was measured under GLP according to OECD 103 / EU A2 guideline, by differential scanning calorimetry method. Two samples of test substance were placed in crucible with pierced lid and were subjected to a thermal program from 25 -600 °C at 10 °C/min.
No boiling temperature of the test item has been recorded.
The test item inflated and there was signs of decomposition
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:
- EU Method A.1 (Melting / Freezing Temperature)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 102 (Melting point / Melting Range)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- differential scanning calorimetry
Test material
- Reference substance name:
- Protein hydrolyzates, soya
- EC Number:
- 271-770-5
- EC Name:
- Protein hydrolyzates, soya
- Cas Number:
- 68607-88-5
- IUPAC Name:
- Enzymatic hydrolysis products of Glycine soya
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: beige powder
- Storage: in a dark place at room temperature
- Batch : 16 187
- Manufacturing date: July 5th 2016
- Expiry date: July 5th 2018
Constituent 1
Results and discussion
Melting / freezing point
- Key result
- Atm. press.:
- >= 101 320 - <= 101 330 Pa
- Decomposition:
- yes
- Remarks:
- A black residue was observed after the experimentation, the powder inflated. No melting point of the test item was recorded.
- Remarks on result:
- other: A black residue was observed after the experimentation, the powder inflated. No melting point of the test item was recorded.
Applicant's summary and conclusion
- Conclusions:
- No melting point was recorded.
- Executive summary:
The melting point of the test substance was tested under GLP according to EU A1 and OECD 102, by differential scanning calorimetry. Two runs were performed under nitrogen atmosphere, and no melting point was recorded.
The test item inflated and there was signs of decomposition
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