Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-03-04 till 2008-04-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guidline conform study under GLP without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
capillary method
Remarks:
and thermal analysis

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 40840/A TE
- Substance type: colouring dye
- Physical state: solid, dark red powder
- Analytical purity: approx. 78.9% org. part (NA-salt), MC: 37.7%, Oligomers: 19.2%
- Purity test date:
- Lot/batch No.: ROE 358 BOP 01/07
- Expiration date of the lot/batch: June 30, 2012
- Storage condition of test material: At room temperature at about 20°C

Results and discussion

Melting / freezing point
Melting / freezing pt.:
>= 280 °C
Atm. press.:
98.2 kPa
Decomposition:
yes
Decomp. temp.:
>= 280 °C
Sublimation:
no

Any other information on results incl. tables

Main Test: To confirm the result of the preliminary test, a second run was performed. A test item amount of 7.72 mg was heated up from 25 °C to 400 °C at a rate of 10 °C/min. An endothermic reaction started at about 59 °C, followed by an exothermic reaction starting at about 280 °C. After the experiment, the sample was still powdery but dark in colour, loosing about 21% of its weight.

Applicant's summary and conclusion

Conclusions:
The test item does not melt under the conditions of the test. Decomposition of FAT 40840/A TE started at about 280°C (according to capillary method)
Executive summary:

The Study was carried out in accordance with the OECD guideline 102 (Melting Point / Mellting Range). Standard commercially available apparaturs was used in compliance with the manufacturer's operating instructions. The main test was perfomed with the DSC method . A test item amount of 7.72 mg was heated up from 25 °C to 400 °C at a rate of 10 °C/min. FAT 40840/A TE does not melt under the conditions of the test. Decomposition of FAT 40840/A TE started at about 280°C (according to capillary method).