5-Amino-N,N'-Bis(2,3-Dihydroxypropyl)-2,4,6-Triiodoisophtalamide

Vapour pressure

Administrative data

Endpoint:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11. - 17.10. 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: isothermal thermogravimetry

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

474-080-4

EC Name:

-

Cas Number:

76801-93-9

Molecular formula:

C14H18I3N3O6

IUPAC Name:

5-amino-N1,N3-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide

impurity 1

Reference substance name:

Unknown impurities

Molecular formula:

Not available

IUPAC Name:

Unknown impurities

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 00104016
- Expiration date of the lot/batch: 12/2020

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
- Stability under test conditions: Stable

Results and discussion

Vapour pressure

Remarks on result:

not determinable

Applicant's summary and conclusion

Conclusions:

Vapour pressure of test item, ATIBA-A, could not be determined under test conditions. At temperature range from 60 °C to 150 °C, the losses of weight recorded during the measurements were too low, fluctuating and without tendency to increase with increasing temperature. The higher temperature could not be used owing to decomposition of impurity(ies), which would influence the final results, followed by melting of test item and thermal decomposition of test item.

Executive summary:

The vapour pressure of test item, ATIBA-A, was investigated. The isothermal thermogravimetry effusion method was used.

The procedures used in the study were in accordance with:

- Method A.4 Vapour Pressure, 1.5.6. Effusion method: isothermal thermogravimetry, Commission Regulation (EC) No 761/2009 Anex 1, Published in O.J. L 220, 2009

- OECD Test Guideline No.104, page 9 Effusion method: isothermal thermogravimetry, Adopted on 23 March 2006

Vapour pressure of test item, ATIBA-A, could not be determined under test conditions. At temperature range from 60 °C to 150 °C, the losses of weight recorded during the measurements were too low, fluctuating and without tendency to increase with increasing temperature.

The higher temperature could not be used owing to decomposition of impurity(ies), which would influence the final results, followed by melting of test item and thermal decomposition of test item.