Saccharides of mannose and galactose from Ceratonia Siliqua seed

Boiling point

Administrative data

Endpoint:

boiling point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted according to an internationally recognised method, and under GLP. The test substance is adequately characterised. Therefore, full validation applies.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Remarks:

4.2

Reference

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

january 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted according to an internationally recognised method, and under GLP. The substance is considered to be adequately characterised with its purity. Therefore full validation applies.

Reason / purpose for cross-reference:

reference to same study

Remarks:

4.3

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Deviations:

no

Principles of method if other than guideline:

N/A

GLP compliance:

yes

Type of method:

differential scanning calorimetry

Key result

Atm. press.:

>= 101 320 - <= 101 330 Pa

Decomposition:

yes

Remarks:

When heating, the test item became black and hard. A black residue was observed in the crucible.

Decomp. temp.:

>= 225 - <= 275 °C

Remarks on result:

other: No melting point was recorded, the test item became black and hard.

Conclusions:

No melting point was recorded.

Executive summary:

The melting point of the test substance was tested under GLP according to EU A1 and OECD 102, by differential scanning calorimetry. Three runs were performed under nitrogen atmosphere, and no melting point was recorded.

The the test item became black and hard.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 103 (Boiling Point)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method A.2 (Boiling Temperature)

Deviations:

no

Principles of method if other than guideline:

N/A

GLP compliance:

yes

Type of method:

differential scanning calorimetry

Test material

Test material information

Constituent 1

Reference substance name:

Saccharides of mannose and galactose from Ceratonia Siliqua seed

IUPAC Name:

Saccharides of mannose and galactose from Ceratonia Siliqua seed

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: beige powder
- Storage: in a dark place at room temperature
- Batch : 14 262
- Manufacturing date: September 19th 2014
- Expiry date: September 19th 2018

Results and discussion

Boiling point

Key result

Atm. press.:

>= 101 320 - <= 101 330 Pa

Decomposition:

yes

Remarks:

No boiling point was recorded. The test item became black but did not harden.

Remarks on result:

other: No boiling point was recorded. The test item became black but did not harden.

Applicant's summary and conclusion

Conclusions:

No boiling point was recorded

Executive summary:

The determination of boiling point test was measured under GLP according to OECD 103 / EU A2 guideline, by differential scanning calorimetry method. Two samples of test substance were placed in crucible with pierced lid and were subjected to a thermal program from 25 -600 °C at 10 °C/min. Two determinations were performed.

No boiling temperature of the test item has been recorded.