Registration Dossier

Administrative data

Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The experimental work associated with this study was carried out between 11 November 2016 and 22 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
GLP compliance:
yes (incl. QA statement)
Type of method:
gas saturation method

Test material

Constituent 1
Chemical structure
Reference substance name:
Pidolic acid
EC Number:
202-700-3
EC Name:
Pidolic acid
Cas Number:
98-79-3
Molecular formula:
C5H7NO3
IUPAC Name:
(2S)-5-oxopyrrolidine-2-carboxylic acid
Test material form:
solid: particulate/powder
Details on test material:
white solid crystalline powder
Specific details on test material used for the study:
Test substances: (2S)-5-oxopyrrolidine-2-carboxylic acid Technical Materials
Acid Source: (2S)-5-oxopyrrolidine-2-carboxylic acid (Acid Source)
Salt Source: (2S)-5-oxopyrrolidine-2-carboxylic acid (Potassium Salt)
Received on: 8th November 2016
DNAL Sample Numbers: DNA3730/1-2
Reference Standard: (S)-(-)-2-Pyrrolidinone-5-carboxylic acid reference standard
Received on: 6th January 2017

Results and discussion

Vapour pressureopen allclose all
Key result
Test no.:
#1
Temp.:
ca. 25 °C
Vapour pressure:
< 2 other: mPa
Remarks on result:
other: using 360L of gas flow through the column
Key result
Test no.:
#2
Temp.:
ca. 25 °C
Vapour pressure:
< 8 other: mPa
Remarks on result:
other: using 72L of gas flow through the column.

Any other information on results incl. tables

Vapour Pressure (72L of gas through the column) Results Reference Standard

 Description  Data File  Retention time (mins)  Unit Area  Response Factor  Concentration (mg/mL)  Weight in (g) on sorbant tube  Vapour pressure (Pa)  Vapour pressure (mPa)
 0.05mg/mL L-PCA  L1603S9  5.18  414.04  0.000121           
 L-PCA Ref Standard/A VP Front 1 Day  LL603V1  ND  ND       <0.002  0.00003  <0.008  <0.8
 L-PCA Ref Standard/B VP Front 1 Day  LL603V2  ND  ND    <0.002   0.00003   <0.008  <8.0
 0.05mg/mL L-PCA  L1603S10  5.19  411.35  0.000122    Mean  <0.008  <8.0
 L-PCA Ref Standard/A VP Back 1 Day  LL603V3  ND  ND          <0.002  0.00003  <0.008  <8.0
 L-PCA Ref Standard/B VP Back 1 Day LL603V4   ND  ND  <0.002  0.00003  <0.008  <8.0
0.05mg/mL L-PCA  L1603S11  5.20  409.02    Mean:  <0.008  <8.0

Vapour pressure (360L o f gas through the column) Results Reference Standard

 Description  Data File  Retention time (mins)  Unit Area  Response Factor  Concentration (mg/mL)  Weight in (g) on sorbant tube  Vapour pressure (Pa)  Vapour pressure (mPa)
 0.05mg/mL L-PCA  L1603S11  5.20  409.02  0.000121           
 L-PCA Ref Standard/A VP Front 5 Day  LL603V5  ND  ND       <0.002  0.00003  <0.002  <2.0
 L-PCA Ref Standard/B VP Front 5 Day  LL603V6  ND  ND    <0.002   0.00003   <0.002  <2.0
 0.05mg/mL L-PCA  L1603S12  5.21  417.38  0.000118    Mean  <0.002  <2.0
 L-PCA Ref Standard/A VP Back 5 Day  LL603V7  ND  ND          <0.002  0.00003  <0.002  <2.0
 L-PCA Ref Standard/B VP Back 5 Day LL603V8   ND  ND  <0.002  0.00003  <0.002  <2.0
0.05mg/mL L-PCA  L1603S13  5.21  428.79    Mean:  <0.002  <2.0

Where:

Response Factor= 0.05/mean standard bracket area

Concentration (mg/mL) =Less than Lowest standard concentration (LOQ)

Molecular Weight= 129.12

Temperature (K) = 298

Gas Constant= 8.314

Volume (m3) =((Time (in hours) x 60 x 50)/1000)/1000

Grams on tube = Concentration x 15/ 1000

Vapour Pressure Pa= (grams on tube /volume) x ((8.314 x 298)/129.12)

Vapour Pressure mPa = Vapour Pressure Pa x 1000

No significant deviation was recorded in this part of the study.

Applicant's summary and conclusion

Conclusions:
According to the results obtained in this test, the mean Vapour Pressure of (2S)-5-oxopyrrolidine-2-carboxylic acid is <2.0mPa at 25°C using 360L of gas flow through the column.
According to the results obtained in this test, the mean Vapour Pressure of (2S)-5-oxopyrrolidine-2-carboxylic acid is <8.0mPa at 25°C using 72L of gas flow through the column.