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Melting point / freezing point

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Reference
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

 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.’

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).

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 reaction mass of tris(dipentyldithiocarbamato-S,S')antimony and [bis(2-ethylhexyl)dithiocarbamato-S,S']bis(dipentyldithiocarbamato-S,S')antimony and bis[bis(2-ethylhexyl)dithiocarbamato-S,S'](dipentyldithiocarbamato-S,S')antimony and  tris[bis(2-ethylhexyl)dithiocarbamato-S,S']antimony was < -20°C.

(Intertek Pharmaceutical Services, 2018).