3,5,8-Trioxa-4-phosphaundec-10-en-1-aminium, 4-hydroxy-N,N,N,10-tetramethyl-9-oxo-, inner salt, 4-oxide

Density

Administrative data

Endpoint:

relative density

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 November 2008 to 19 March 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with the relevant international guideline (OECD 109) and the report included all required information in order to make the study wholly reproceable.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 109 (Density of Liquids and Solids)

Deviations:

no

Principles of method if other than guideline:

N/A

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Regulation (1992)

Type of method:

pycnometer method

Remarks:

performed in triplicate

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

417-560-0

EC Name:

-

Cas Number:

67881-98-5

Molecular formula:

C11H22NO6P

IUPAC Name:

trimethyl[2-({2-[(2-methylprop-2-enoyl)oxy]ethyl phosphonato}oxy)ethyl]azanium

Details on test material:

- Name of test material (as cited in study report): HEMA-PC (2-Methacryloyloxyethyl-2'-(trimethylammoniumethyl) phosphate
- Substance type: Pure Active Substance
- Physical state: Solid
- Analytical purity: 99 % (98-101 %)
- Impurities (identity and concentrations): 0.1 % by area (HPLC)
- Purity test date: 29 September 2008
- Lot/batch No.: SS148076
- Expiration date of the lot/batch: 27 October 2009 (lab default)
- Stability under test conditions: Stable
- Storage condition of test material: Under nitrogen at -20 degrees celsius in the dark.
- Other: N/A

Results and discussion

Density

Type:

relative density

Density:

1.22 other: g/mL

Temp.:

21.5 °C

Any other information on results incl. tables

The coefficient of variation reported for the determination of relative density was 2.4 %.

Table 1. Relative Density: Results of Calibration of Pycnometers

Pycnometer ID	Weight of Empty Pycnometer (g)	Weight of full Pycnometer (g)	Weight of Milli-Q Water (g)	Temperature (^oC)	Density of Milli-Q Water (g/mL)	Volume of Pycnometer (mL)
4016	21.4345	46.1241	24.6896	20.0	0.9982063	24.7340
4019	21.6339	46.7897	23.1648	20.0	0.9982063	25.2100
4026	22.0287	46.3630	24.3343	20.0	0.9982063	24.3780

Table 2. Relative Density: Density of Wetting Solution

Pycnometer ID	Weight of Empty Pycnometer (g)	Weight of full Pycnometer (g)	Weight of Milli-Q Wetting Solution (g)	Temperature (^oC)	Volume of Pycnometer (mL)	Density (g/mL)
4016	21.4343	40.7989	19.3646	20.0	24.7340	0.7829
4019	21.6342	41.3723	19.7381	20.0	25.2100	0.7829
4026	22.0291	41.1154	19.0863	20.0	24.3780	0.7829

Table 3. Relative Density: Density of HEMA-PC

Pycnometer ID	Weight of Empty Pycnometer (g)	Weight of Pycnometer and Test Item (g)	Weight of Test Item (g)	Volume of Pycnometer (mL)	Weight of Full Pycnometer (g)	Weight of Wetting Solution (g)	Temperature (^oC)	Density of Wetting Solution (g/mL)	Volume of Wetting Solution (mL)	Density of Test Item (g/mL)
4016	21.4376	27.4535	6.0159	24.7340	42.9036	15.4501	20.8	0.7829	19.7344	1.2033
4019	21.6349	26.8646	5.2297	25.2100	43.3281	16.4635	21.2	0.7829	21.0289	1.2508
4026	22.0295	28.1892	6.1687	24.3780	43.2500	15.0518	22.4	0.7829	19.2257	1.1973

Applicant's summary and conclusion

Conclusions:

Relative density was successfully determined for HEMA-PC.

Relative Density = 1.2171 g/mL (Coefficient of variation = 2.4 %).

Executive summary:

Charles River carried out relative density testing on HEMA-PC in accordance with OECD 109 (1995) Pycnometer method.

Relative Density = 1.2171 g/mL (Coefficient of variation = 2.4 %).