Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The determination was carried out using a procedure designed to be compatible with Method A.4 Vapour Pressure of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
GLP compliance:
yes (incl. certificate)
Type of method:
effusion method: vapour pressure balance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
White powder
Specific details on test material used for the study:
Batch Number : 18113833

Results and discussion

Vapour pressure
Key result
Temp.:
ca. 25 °C
Vapour pressure:
ca. 5.4 Pa

Any other information on results incl. tables

Recorded temperatures, mass differences and the resulting calculated values of vapor pressure are shown in the joint document KS95WT.

A total of 6 runs were completed for the main sequence. The values of vapor pressure at 25 °C has been extrapolated from each graph. (see table 7 of the

KS95WT document).

Equilibrium with regard to vapor pressure was assessed to have been reached over these 6 runs. Thus all 6 runs have been used to calculate the definitive vapor pressure value for the test item.

Applicant's summary and conclusion

Conclusions:
The vapor pressure of the test item has been determined to be 5.4 x 10E-7 Pa at 25 ºC.
Executive summary:

The vapor pressure of Mephtamin-HCL has been determined to be 5.4 x 10E-7 Pa at 25 °C, using the vapor pressure balance method, designed to be compatible with Method A.4 Vapour Pressure of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006.