1,4-α-glucan branching enzyme

Vapour pressure

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

vapour pressure

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

02 September 2019 - 05 November 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The data has been generated for a study with alpha-amylase, but similar results are expected for 1,4-alpha-glucan branching enzyme.

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Version / remarks:

23 March 2006

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: vapour pressure balance

Key result

Temp.:

25 °C

Vapour pressure:

0.003 Pa

Remarks on result:

other: mean value

Key result

Test no.:

#3

Temp.:

25 °C

Vapour pressure:

0.005 Pa

Key result

Test no.:

#4

Temp.:

25 °C

Vapour pressure:

0.005 Pa

Key result

Test no.:

#5

Temp.:

25 °C

Vapour pressure:

0.004 Pa

Key result

Test no.:

#6

Temp.:

25 °C

Vapour pressure:

0.002 Pa

Key result

Test no.:

#7

Temp.:

25 °C

Vapour pressure:

0.002 Pa

The test item did not change in appearance under the conditions used in the determination.

A total of 10 runs were completed for the main sequence. Runs 1 and 2 have not been utilised as the nature of the plots shows the sample was still equilibrating. With regard to equilibrium, this has been assessed to have been reached over runs 3 to 7 which were used to calculate the vapor pressure. Due to the small amount of vapor produced by the test item, runs 8 to 10 produced readings which were too low and variable to be used in the calculation.

The results may represent rounded values obtained by calculations based on the exact raw data.

Conclusions:

The vapor pressure of the test item has been determined to be 3.44 x 10^-3 Pa at 25 ºC, calculated from the mean of 5 individual runs.

Executive summary:

The vapor pressure balance method was performed on a freeze-dried aliquot of test item over the temperature range 60 °C to 70 °C, and the calculated result taken from a mean of 5 individual runs.

The vapor pressure Alpha-amylase, batch PPY31071 has been determined to be 3.44 x 10^-3 Pa at 25 °C, using the vapor pressure balance method, designed to be compatible with Method A.4 Vapour Pressure of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006.

Reference 2

Endpoint:

vapour pressure

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

02 September 2019 - 07 November 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The data has been generated for a study with cellulase, but similar results are expected for 1,4-alpha-glucan branching enzyme.

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Version / remarks:

23 March 2006

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: vapour pressure balance

Key result

Temp.:

25 °C

Vapour pressure:

0.004 Pa

Remarks on result:

other: mean value

Key result

Test no.:

#2

Temp.:

25 °C

Vapour pressure:

0.007 Pa

Key result

Test no.:

#3

Temp.:

25 °C

Vapour pressure:

0.003 Pa

Key result

Test no.:

#4

Temp.:

25 °C

Vapour pressure:

0.003 Pa

Key result

Test no.:

#5

Temp.:

25 °C

Vapour pressure:

0.005 Pa

The test item did not change in appearance under the conditions used in the determination.

A total of 10 runs were completed for the main sequence. Run 1 has not been utilised as the nature of the plot shows the sample was still equilibrating. With regard to equilibrium, this has been assessed to have been reached over runs 2 to 5 which were used to calculate the vapor pressure. Due to the small amount of vapor produced by the test item, runs 6 to 10 produced readings which were too low and variable to be used in the calculation.

The results may represent rounded values obtained by calculations based on the exact raw data.

Conclusions:

The vapor pressure of the test item has been determined to be 4.15 x 10^-3 Pa at 25 ºC, calculated from the mean of 4 individual runs.

Executive summary:

The vapor pressure balance method was performed on a freeze-dried aliquot of test item over the temperature range 60 °C to 70 °C, and the calculated result taken from a mean of 4 individual runs.

The vapor pressure of Cellulase, batch PPC31776 has been determined to be 4.15 x 10^-3 Pa at 25 °C, using the vapor pressure balance method, designed to be compatible with Method A.4 Vapour Pressure of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006.

Reference 3

Endpoint:

vapour pressure

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

02 September 2019 - 06 November 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The data has been generated for a study with glucoamylase, but similar results are expected for 1,4-alpha-glucan branching enzyme.

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Version / remarks:

23 March 2006

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: vapour pressure balance

Key result

Temp.:

25 °C

Vapour pressure:

0.002 Pa

Remarks on result:

other: mean value

Key result

Test no.:

#3

Temp.:

25 °C

Vapour pressure:

0.002 Pa

Key result

Test no.:

#4

Temp.:

25 °C

Vapour pressure:

0.002 Pa

Key result

Test no.:

#5

Temp.:

25 °C

Vapour pressure:

0.002 Pa

Key result

Test no.:

#6

Temp.:

25 °C

Vapour pressure:

0.002 Pa

The test item did not change in appearance under the conditions used in the determination.

A total of 6 runs were completed for the main sequence. Runs 1 and 2 have not been utilised as the nature of the plots shows the sample was still equilibrating. With regard to equilibrium, this has been assessed to have been reached over the remaining 4 runs which were used to calculate the vapor pressure.

The results may represent rounded values obtained by calculations based on the exact raw data.

Conclusions:

The vapor pressure of the test item has been determined to be 1.95 x 10^-3 Pa at 25 ºC, calculated from the mean of 4 individual runs.

Executive summary:

The vapor pressure balance method was performed on a freeze-dried aliquot of test item over the temperature range 60 °C to 70 °C, and the calculated result taken from a mean of 4 individual runs.

The vapor pressure of Glucoamylase, batch PPY59305 has been determined to be 1.95 x 10^-3 Pa at 25 °C, using the vapor pressure balance method, designed to be compatible with Method A.4 Vapour Pressure of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006.

Reference 4

Endpoint:

vapour pressure

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

02 September 2019 - 06 November 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The data has been generated for a study with subtilisin, but similar results are expected for 1,4-alpha-glucan branching enzyme.

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Version / remarks:

23 March 2006

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

effusion method: vapour pressure balance

Key result

Temp.:

25 °C

Vapour pressure:

0.007 Pa

Remarks on result:

other: mean value

Key result

Test no.:

#2

Temp.:

25 °C

Vapour pressure:

0.008 Pa

Key result

Test no.:

#3

Temp.:

25 °C

Vapour pressure:

0.007 Pa

Key result

Test no.:

#4

Temp.:

25 °C

Vapour pressure:

0.006 Pa

Key result

Test no.:

#5

Temp.:

25 °C

Vapour pressure:

0.006 Pa

Key result

Test no.:

#6

Temp.:

25 °C

Vapour pressure:

0.007 Pa

Key result

Test no.:

#7

Temp.:

25 °C

Vapour pressure:

0.007 Pa

The test item did not change in appearance under the conditions used in the determination.

A total of 7 runs were completed for the main sequence. Run 1 has not been utilised as the nature of the plot shows the sample was still equilibrating. With regard to equilibrium, this has been assessed to have been reached over the remaining 6 runs which were used to calculate the vapor pressure.

The results may represent rounded values obtained by calculations based on the exact raw data.

Conclusions:

The vapor pressure of the test item has been determined to be 6.89 x 10^-3 Pa at 25 ºC, calculated from the mean of 6 individual runs.

Executive summary:

The vapor pressure balance method was performed on a freeze-dried aliquot of test item over the temperature range 40 °C to 50 °C, and the calculated result taken from a mean of 6 individual runs.

The vapor pressure of Subtilisin, batch PPA52404 has been determined to be 6.89 x 10^-3 Pa at 25 °C, using the vapor pressure balance method, designed to be compatible with Method A.4 Vapour Pressure of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 104 of the OECD Guidelines for Testing of Chemicals, 23 March 2006.

Description of key information

The vapor pressure of four different enzymes (freeze-dried) was measured using the vapor pressure balance method at temperatures 40-50 °C and 60-70 °C (below denaturing temperature). Several runs were conducted for each enzyme and a mean value was caculated for each enzyme. All enzymes had vapor pressure in the order of 10^-3 Pa.

The value presented below is an average of the vapor pressure of the 4 tested enzymes and it is assumed to be similar for enzymes in general.

Key value for chemical safety assessment

Vapour pressure:

0.004 Pa

at the temperature of:

25 °C

Additional information

The vapor pressure of enzymes is assumed to be extremely low (1-4). This is supported by the conclusion drawn for several enzymes (proteases, amylases, cellulases, lipases) mentioned in HERA reports (1, 2). These reports also concluded that the vapor pressure of these enzymes is below the lowest vapor pressure that can be analytically determined, which was10^-6Pa at the time these reports were issued. Also, NJDOH (3) and NIOSH (4) have mentioned a vapor pressure of approximately 0 mmHg vapor pressure for subtilisin.

References:

1) HERA (2005) Human & Environmental Risk Assessment (HERA) on ingredients of household cleaning products α-Amylases, Cellulases And Lipases, 1st edition.

2) HERA (2007) Human & Environmental Risk Assessment (HERA) on ingredients of household cleaning products - Subtilisins (Protease), 2ndedition.

3) NJDOH (2003) New Jersey Department of Health and Senior Services – Hazardous Substances Fact Sheet: Subtilisins, available via: https://nj.gov/health/eoh/rtkweb/documents/fs/1750.pdf (accessed 13/08/2019).

4) NIOSH (2018) The National Institute for Occupational Safety and Health (NIOSH) – Subtilisins, available via: https://www.cdc.gov/niosh/npg/npgd0572.html (accessed 13/08/2019).