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:
- 21 February 2018 - 25 October 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- GLP compliance:
- yes
- Type of method:
- method to determine freezing temperature
- Specific details on test material used for the study:
- Physical state: Clear amber liquid
Stability under storage conditions: Stable at room temperature
Storage condition of test material: Ambient - Key result
- Melting / freezing pt.:
- < -20 °C
- Remarks on result:
- other: The study does not need to be conducted below alover limit of -20 Deg.C
- Conclusions:
- In an EU Method A.1 study, conducted according to GLP, the freezing temperature of the substance was determined to be <-20°C (Intertek Pharmaceutical Services, 2018).
- Executive summary:
The preliminary test indicates a freezing point of < -20 °C for the Test Item. Therefore, a full freezing point determination is not required.
In an EU Method A.1 study, conducted according to GLP, the freezing temperature of the substance was determined to be <-20°C (Intertek Pharmaceutical Services, 2018).
Reference
Freezing Point Observations
Temperature |
Sample Appearance |
4 °C |
Test Item mobile upon inversion of vial, i.e. not frozen |
-20 °C |
Test Item mobile upon inversion of vial, i.e. not frozen |
-80 °C |
Test Item less fluid than -20 °C but still mobile, i.e. not frozen |
The preliminary test indicates a freezing point of < -20 °C for the Test Item. Therefore, a full freezing point determination is not required as described in ECHA Guidance R.7.1.2:
Column 2 of REACH Annex VII provides the following specific rules for adaptation of the standard information requirement for melting point/freezing point:
‘The study does not need to be conducted below a lower limit of
-20 °C.’
‘Therefore, Annex 7 to REACH does not require determination of the
melting point below a lower limit of -20 °C. The lower limit should be
confirmed through testing, except where a (Q)SAR indicates a melting
point of -50 °C or lower.’
Description of key information
In an EU Method A.1 study, conducted according to GLP, the freezing temperature of the substance was determined to be <-20°C (Intertek Pharmaceutical Services, 2018).
Key value for chemical safety assessment
Additional information
In an EU Method A.1 study, conducted according to GLP, the freezing point of the test material is < -20°C (Intertek Pharmaceutical Services, 2018).
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.
