Registration Dossier

Administrative data

Endpoint:
boiling point
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the substance is a solid which decomposes before boiling
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
-
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
-
Deviations:
no
GLP compliance:
no
Type of method:
capillary method
Specific details on test material used for the study:
- Analytical purity: > 98.4%
 - Lot/batch No.: 0159115
 - Expiration date of the lot/batch: 21/02/2018
Key result
Melting / freezing pt.:
>= 110 - <= 111 °C
Atm. press.:
ca. 1 atm
Decomposition:
yes

Findings

Pre-Test

The test substance melted at 111 °C to a very dark opaque liquid.

Main Study

The following values were recorded:

Values Main Study

Melting point/range

Begin

End

First determination

110.2 °C (383.4 K)

111.0 °C (384.2 K)

Second determination

110.0 °C (383.2 K)

111.0 °C (384:2 K)

Results and Validity

Result Test substanceIMEXINE OBA/50 SEC

The mean between both determinations gives the following value for the melting range:

Melting range:                                           110.1 to 111:0 °C (383.3 to 384.2 K)

Standard deviation:                                  0.1 (begin); 0:0 (end)

Estimated accuracy:                                 ± 0.2 °C

Validity

All validity criteria were met, as can be taken from the following table.

Validity

Parameter

Criterion

Found

Assessment

Difference between duplicate determinations

=<0.5 K

0.2 K

valid

Difference between begin and end of melting process

=<0.5 K

0.9 K

melting range is stated

 

Conclusions:
The mean between both determinations gives the following value for the melting range:
Melting range: 110.1 to 111:0 °C (383.3 to 384.2 K)
Standard deviation: 0.1 (begin); 0:0 (end)
Estimated accuracy: ± 0.2 °C
Executive summary:

The melting point of the test item has been determined with a not-GLP compliant study, according to the stadard guideline OECD TG 102. Using the capillary method, the mean between both determinations gives the following value for the melting range:

Melting range:       110.1 to 111:0 °C (383.3 to 384.2 K)

Standard deviation:       0.1 (begin); 0:0 (end)

Estimated accuracy:       ± 0.2 °C

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion