Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
- Experimental dates: 20-21 September 2020
- 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. No deviation affected the quality of the study. The substance is adequately characterised. Therefore full validation applies.
- Qualifier:
- according to guideline
- Guideline:
- other: British Standard Method BS4633 - Method for the Determination of Crystallizing Point
- Version / remarks:
- (1970)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 102 (Melting point / Melting Range)
- Version / remarks:
- (1995)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- issued on 01/08/2019
- Type of method:
- method to determine freezing temperature
- Key result
- Melting / freezing pt.:
- < -20 °C
- Conclusions:
- No further testing is required (< - 20°C).
- Executive summary:
The freezing point of the test substance was determined, under GLP, according to OECD 102/EU A1 guideline, using BS4633 method for the determination of crystallizing point.
An aliquot was placed in a cooling bath, and the temperature was recorded at regular intervals.
No freezing was observed down to the minimum test temperature of -20°C.
Reference
In a trial determination, the test item did not solidify as the temperature was decreased from ambient temperature down to -20°C. No further testing was necessary, as the sample was still liquid at -20°C.
Description of key information
Freezing point < -20°C.
No further testing is required.
Key value for chemical safety assessment
Additional information
A fully reliable experimental study (Covance 2021), conducted according to a recognized OECD/EC/BS guideline, and under GLP, is available. It is considered as a key study.
As no freezing was observed down to -20°C, the result is expressed as a limit value, and cannot be retained as key data.
A supporting study (Phytosafe 2013) was added for information on the melting transition, but its validity could not be granted.
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.
