Registration Dossier
Registration Dossier
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EC number: 500-500-3 | CAS number: 161074-67-5
Melting point / freezing point
Administrative data
Link to relevant study record(s)
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January-March 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: test performed following pharmacopeia method
- Qualifier:
- according to guideline
- Guideline:
- other: USP method<651>
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- Principles of method if other than guideline:
- The product is introduced in a tube, containing a mercury thermometer on a height of 5 to 5.7 cm. Put the tube in a cold bath (mixture of ice, salt and acetone), having a temperature of about -12°C. The product temperature is recorded every 30 seconds until the product is frozen or until the bath temperature is reached (approximately -10°C).
- GLP compliance:
- no
- Type of method:
- other: The temperature at which a substance passes from the liquid to the solid state upon cooling is a useful index to purity if heat is liberated when the solidification takes place, provided that any impurities present dissolve in liquid and not in solid.
- Specific details on test material used for the study:
- Name of the test material (as cited in the study report): PROTEOL OAT
Lot / batch: LR10746 - Melting / freezing pt.:
- < -10 °C
- Atm. press.:
- 1 atm
- Decomposition:
- no
- Remarks on result:
- other: The batch temperature could not reach - 20°C because of the solvant mixture used: ice, salt and acetone
- Conclusions:
- Freezing temperature of the substance: Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts, is less than -10°C.
- Executive summary:
test material: the liquid marketed product "Proteol OAT" which contains ca.27.5% of the solid substance "Glutens, hydrozylates, reaction products with lauroyl chloride, sodium salts".
freezing temperature: less than -10°C.
Reference
Description of key information
test material: the liquid marketed product "Proteol OAT" which contains ca.27.5% of the solid substance "Glutens, hydrozylates, reaction products with lauroyl chloride, sodium salts".
Freezing temperature is less than -10°C at 101.3 kPa.
Key value for chemical safety assessment
- Melting / freezing point at 101 325 Pa:
- -10 °C
Additional information
The study has been conducted according to pharmacopea method USP<651>.
The test item temperature is recorded until the bath temperature is reached (approximately -10°C).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
