Reaction mass of m-terphenyl and o-terphenyl

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018-03-07 - 2017-07-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The department of health of the government of the united kingdom

Type of method:

flask method

Specific details on test material used for the study:

Identification: m- & o-terphenyl rxn mass
Appearance/Physical state: a cream colored solid block
Storage conditions: approximately 4 °C, in the dark, under nitrogen

Key result

Water solubility:

<= 0 g/L

Conc. based on:

test mat.

Temp.:

20 °C

pH:

7

Details on results:

see "Any other information on results inc. tables"

Preliminary Test

The preliminary estimate of the water solubility at 20.0 ± 0.5 °C was less than 1.0 x 10-4 g/L. The solution had a pH of 6.2.

Definitive Test

The mean total peak areas relating to the standard and sample solutions are shown in the following table:

Solution	Mean Total Peak Area
Standard 2.11 mg/L	2.8128 x 10^5
Standard 2.03 mg/L	2.7045 x 10^5
Standard solution matrix blank	none detected
Sample solution matrix blank	none detected
Sample 1A	3.3639 x 10^4
Sample 1B	3.9213 x 10^4
Sample 2A	2.6201 x 10^4
Sample 2B	2.8023 x 10^4
Sample 3A	4.0894 x 10^4
Sample 3B	3.1571 x 10^4

The concentration (g/L) of test item in the sample solutions is shown in the following table:

Sample Number	Time Shaken at 30 ºC (hours)	Concentration (g/L)	Solution pH
1	24	<1.0 x 10^-4	6.8
2	48	<1.0 x 10 ^-4	6.9
4	72	<1.0 x 10^-4	7.0

Overall result: <1.0 x 10^-4 g/L at 20.0 ± 0.5 ºC

Validation

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0.2 to 5.0 mg/L. The results were satisfactory with a first order correlation coefficient (r) of 0.9999 being obtained.

Assessment of the sample extraction procedure was performed and proved adequate for the test. At a nominal fortification concentration of 0.1 mg/L, a mean percentage recovery of 98.9% was obtained (n = 5, range 97.9 to 99.6%).

Test sample concentrations have not been corrected for the recovery of analysis.

Discussion

On completion of the re-equilibration period, the samples were clear and colorless solutions with excess, undissolved test item remaining visibly present. After centrifugation, the

supernatants were isolated for analysis. Each supernatant was visually observed to be clear, colorless and free from un-dissolved test item prior to extraction.

On analysis of the sample solutions, a limited response was observed at the retention time of the first of the two dominant components; however, no response was observed for the second component. In addition, the response obtained for the first component remained below the validated limit of quantification generated from the procedural recoveries. Therefore a limit value has been reported for the overall water solubility result.

Conclusion

The water solubility of the test item has been determined to be less than 1.0 x 10^-4 g/L of solution at 20.0 ± 0.5 °C.

Conclusions:

The water solubility of the test item has been determined to be less than 1.0 x 10E-4 g/L of solution at 20.0 ± 0.5 °C.

Executive summary:

The water solubility determination was carried out by a flask method according to GLP, using a procedure designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995. The water solubility of the test item has been determined to be less than 1.0 x 10^-4 g/L of solution at 20.0 ± 0.5 °C.

Description of key information

The water solubility determination was carried out by a flask method according to GLP, using a procedure designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995. The water solubility of the test item has been determined to be less than 1.0 x 10^-4g/L of solution at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

Water solubility:

0 g/L

at the temperature of:

20 °C

Additional information

The water solubility of the test item has been determined to be less than 1.0 x 10^-4 g/L of solution at 20.0 ± 0.5 °C. Therefore for chemical safety assessment this limit-value was chosen.