2-(undec-10-enoylamino)-3-phenylpropanoic acid

Vapour pressure

Administrative data

Endpoint:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-06-19 to 2010-04-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

gas saturation method

Remarks:

at 60°C

Test material

Test material information

Constituent 1

Reference substance name:

LCA 08042

IUPAC Name:

LCA 08042

Details on test material:

- Name of test material (as cited in study report): LCA08042
- Substance type: white and beige solid
- Physical state: solid
- Analytical purity: 99.4%
- Lot/batch No.: 0826000002
- Expiration date of the lot/batch: September 16, 2001
- Storage condition of test material: At room temperature (about 20°C)

Results and discussion

Vapour pressure

Vapour pressure 1

Temp.:

60 °C

Vapour pressure:

< 0 Pa

Vapour pressure 2

Temp.:

25 °C

Vapour pressure:

0 Pa

Remarks on result:

other: model calculation based on the Watson Correlation

Any other information on results incl. tables

The results and the amount of nitrogen used to calculate the vapor pressure of the individual experiments are summarized in Table 2 (see attached). The tabulated values represent rounded results that were obtained by calculation using the exact raw data.

Applicant's summary and conclusion

Conclusions:

Based on the gas saturation method, the vapor pressure of LCA08042 was measured at test temperature of 60 °C and was determined to be <3.4 x 10-5 Pa at 60 °C. The vapor pressure of LCA08042 at 60 °C is considered to be below the recommended limit of 10-5 Pa, as given in the Guidelines. Therefore, no further experimental testing was necessary. Additionally a model calculation based on the Watson Correlation was performed: 5.89 x 10-7 Pa (calculated for 25 °C).

Executive summary:

The vapor pressure of LCA08042 was determined according to the EEC Directive 92/69, A.4 “Vapour Pressure” (1992), to the OECD guideline No. 104, “Vapour Pressure” (2006) and to the Council Regulation EC No. 440/2008, A4 “Vapour Pressure” (2008) using the gas saturation method.

Based on the information available, the vapor pressure of LCA08042 was measured at elevated temperature. The experiments were performed at 60 °C. To ensure saturation control, three different flow rates were used. The results and the amount of nitrogen used to calculate the vapor pressure of the individual experiments are summarized in Table 2 (see attached). The tabulated values represent rounded results that were obtained by calculation using the exact raw data.

No test item could be detected in any trap from the experiments at 60 °C. Thus, the vapour pressure was calculated based on the smallest calibration solution measured during the respective HPLC run to be < 3.4 x 10-5 Pa at 60 °C.

Extrapolation to 25 °C was not possible. As no test item could be detected in any trap, the concentration was below the limit of quantification as well as below the limit of detection. Thus, the vapour pressure of LCA08042 is far below 10-5 Pa at 25 °C. The result of an additional calculation using Vapor Pressure Estimations (software MPBPWIN v1.41) was 5.89 x 10-7 Pa (calculated for 25 °C).