Carbamic acid, [5-isocyanato-2(or 4)-methylphenyl]-, C10-14-alkyl esters

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 19, 2001 till August 08, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD Guideline 105 (Water Solubility) under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

column elution method

Test material

Test material information

Constituent 1

Reference substance name:

ZP-TIX 1014

IUPAC Name:

ZP-TIX 1014

Details on test material:

Identity: ZP-TIX 1014
Batch: NW-01-028
Purity > 99%,
Appearance: Solid
Expiration date: 30.12.2001
Storage: At room temperature at about 20°C

The test item consits of three components. For the quantification the peak area sum of these three components was used.

Results and discussion

Water solubility

Water solubility:

< 0.9 mg/L

Temp.:

20 °C

pH:

ca. 7

Details on results:

During the preliminary test the water solubility of ZP-TIX 1014 at room temperature was estimated by a simplified flask method to be lower than the smallest calibration point of 0.9436µg/ml. Therefore, the column elution method was used for the performance of the main test.

During the main test six samples have been analysed in the first run (0.52 ml/min) and six samples during the second run (0.26 ml/min), each with a sampling intervalof one hour. Total elution time was 97.5 hours. The quantification was performed by HPLC. The measured results differ by less than 30%. Therefore the sutdy is considered to be valid.
The test item could not be detected in any of the eluated samples.

In conclusion, the water solubility of ZP-TIX 1014 at 20°C +/- 0.5 °C was determined to be below the smallest calibration point which is < 0.9 mg/l.

Any other information on results incl. tables

Experiment No.	Flow rate [ml/h]	Sample No.	Concentration analysed [µg/ml]	Water solubility calculated [mg/l]	pH
1	31	1	< 0.9436	< 0.9436 *	7
		2	< 0.9436		7
		3	< 0.9436		7
		4	< 0.9436		7
		5	< 0.9436		7
		6	< 0.9436		7
2	16	7	< 0.9436		7
		8	< 0.9436		7
		9	< 0.9436		7
		10	< 0.9436		7
		11	< 0.9436		7
		12	< 0.9436		7

* The measured concentration is below the smalles calibration point of 0.9436 mg/ ml

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
In conclusion, the water solubility of ZP-TIX 1014 at 20°C ± 0.5 °C was determined to be below the smallest calibration point which is < 0.9 mg/L using the column elution method.

Executive summary:

The determination of the water solubility of ZP- TIX 1014 was performed according to the EEC Directive 92/69, A.6 'Water Solubility" (1992) and the OECD guideline No. 105, 'Water Solubility" (adopted July 27, 1995).

During the preliminary test the water solubility of ZP- TIX 1014 at room temperature was estimated by a simplified flask method to be lower than the smallest calibration point of 0.9436 pg/mL. Therefore, the column elution method was used for the performance of the main test.

During the main test six samples have been analysed in the first run (0.52 mL/min) and six samples during the second run (0.26 mL/min), each with a sampling interval of one hour. Total elution time was 97.5 hours. The quantification was performed by HPLC. The measured results differ by less than 30 %. Therefore the study is considered to be valid.

The test item could not be detected in any of the eluate samples.