Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental starting date: 05 March 2018 Experimental completion date: 09 March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
GLP compliance:
yes (incl. certificate)
Type of method:
effusion method: vapour pressure balance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: Beta-Carotene
Appearance/Physical state: brown-red crystalline powder
Lot No: WC01607211
Purity: 100.4% by UV Assay (USP 851)
97.4% by LC Method (USP 621)
Expiry date: 19 July 2018
Storage conditions: Approx. 4 °C, in the dark, under nitrogen

Results and discussion

Vapour pressure
Test no.:
#5
Temp.:
25 °C
Vapour pressure:
< 0.004 Pa

Any other information on results incl. tables

The test item did not change in appearance under the conditions used in the determination.

 

No statistical analyses were performed because the balance readings were too low and variable for a line of best fit to have any meaning. Instead it was considered more appropriate to impose a regression slope on a chosen data point to provide an estimate of the maximum value for the vapor pressure at 25 ºC.

 

Run 5 was chosen because the sample had been under vacuum for the longest period and so degassing would have been the most complete. The reading at 140 ºC (413 K) was chosen because this was the data point which gave the highest estimated vapor pressure at any given temperature when a slope of –1000 K was imposed upon it.

 

The value of –1000 K is an in-house value and is the shallowest slope observed whilst determining the vapor pressure on a wide range of samples using the vapor pressure balance method. Extrapolation to 25 ºC gave a vapor pressure of 4.44 x 10-3Pa which has been used to generate a limit value of less than 4.5 x 10-3Pa.

Applicant's summary and conclusion

Conclusions:
The vapor pressure of the test item has been determined to be less than 4.5 x 10^-3 Pa at 25 ºC.
Executive summary:

The vapor pressure of Beta-Carotene has been determined to be less than 4.5 x 10-3 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.