Registration Dossier
Registration Dossier
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EC number: 415-490-5 | CAS number: 141773-73-1 HELVETOLIDE
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:
- 1994-04-20 to 1994-06-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted according to an internationally recognised method, and under GLP. Purity is specified, however batch number is not identified, so the isomers composition could not be retrieved from the notifier. Therefore full validation cannot apply.
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP compliance programme (inspected on 31 January 1994 / signed on 16 March 1994)
- Type of method:
- method to determine freezing temperature
- Specific details on test material used for the study:
- Storage condition of test material: metal canister at 4°C in the dark
- Key result
- Melting / freezing pt.:
- < 251 K
- Conclusions:
- No further testing is required (< -20°C).
- Executive summary:
The freezing point of the test substance was determined under GLP according to EU A1 guideline.
Two runs were performed. No solidification or freezing was observed down to a temperature of 251 K (-22°C).
Reference
No evidence of solidification or freezing of the test material was observed down to a temperature of 249 K (1st determination) or 251 K (2nd determination).
The lowest value for which two determinations were achieved was retained.
Accuracy is not specified.
Description of key information
Freezing point < -22 °C
No further testing is required.
Key value for chemical safety assessment
Additional information
A reliable experimental study, conducted according to a recognized EC method and under GLP, is available. Despite restrictions due to substance identification (isomers composition unknown), it is considered as a key study. As no solidification or freezing was observed down to -22°C, the result is expressed as a limit value, and cannot be retained as key data for purpose of CSA.
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