Registration Dossier

Physical & Chemical properties

Endpoint summary

Administrative data

Description of key information

Appearance/physical state/colour
The test chemical tripiperazine dicitrate is observed to be a white crystalline powder with faint odour.

Melting point/freezing point
The melting point determination of Test item Tripiperazine dicitrate (CAS No. 144-29-6) was done as per the test guideline OECD 102. The method followed was according to Capillary/metal block. The melting point range was found to be 180.3°C - 185°C at 977.0 hPa.

Boiling point
The boiling point determination of Test item Tripiperazine dicitrate (CAS No. 144-29-6) was done as per the test guideline OECD 103. The method followed was according to Siwoloboff. The test item started to boil and showed foam formation at 208 °C and colour changed from white to dark brown from 220 °C. Thus, the decomposition temperature was inferred to be 220°C at 976.5 hPa.

Density
The density of test item Tripiperazine dicitrate (CAS No. 144-29-6) was determined following OECD Guideline 109 and according to the International Pharmacopoeia, fourth Edition, 2014 using glass cylinder. The pour density and tapped density of Tripiperazine dicitrate (CAS No. 144-29-6) was determined to be 0.6458 gm/cm3 at and 0.7407 gm/cm3 at 28.3°C and 977.6 hPa.

Particle size distribution (Granulometry)

The particle size distribution of test item Tripiperazine dicitrate (CAS No. 144-29-6) was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was found to be in the range of 150 micron to 10 micron.

Vapour pressure
The vapor pressure of the test chemical was estimated using MPBPVP model from EPISUITE. The estimated vapor pressure of piperazine citrate was 56.928 Pa (0.427 mm Hg).

Partition coefficient
The octanol water partition coefficient of the test chemical was estimated using KOWWIN model from EPISUITE. The estimated log Pow of piperazine citrate was -1.15.

Water solubility
The water solubility determination of test item Tripiperazine dicitrate (CAS No. 144-29-6) was done gravimetrically as per the shake flask method using membrane filtration assembly. The solubility was determined to be 540 g/L at 24°C.

Solubility in organic solvents
As per the available data from different handbooks, Piperazine citrate was determined to be insoluble in alcohol, ether and chloroform.

Surface tension
In accordance with column 2 of Annex VII of the REACH regulation, this end point was considered to be scientifically unjsutified for testing since surface activity is not a desired property of the material which is used predominantly in pharma application as an anti-helminthic.

Flash point
The flash point determination of Tripiperazine dicitrate (CAS No. 144-29-6) was done following closed cup method using Pensky-Martens flash point apparatus. The observations were made till 200°C, burning smell was obtained but no flash was observed. Thus flash point was inferred to be greater than 200°C. The test was conducted in replicates and mean flash point was inferred to be greater than 200°C.

Auto flammability
Tripiperazine dicitrate did not catch fire on being exposed to air at room temperature of 27°C pressure of 966 hPa. This indicates that tripiperazine dicitrate is not auto-flammable.

Flammability
Tripiperazine dicitrate does not indicate any ignition when the flame of bunsen burner having temperature of approximately 950°C is brought in contact with it. Thus it can be concluded that tripiperazine dicitrate is not flammable at high temperature. However since such high temperatures are not found under normal circumstances of transportation and use, thus tripiperazine dicitrate was considered non-flammable for chemical safety assessment.

Explosiveness
In accordance with column 2 of Annex VII of the REACH regulation, this end point was considered scientifically unjustified for testing, there are no chemical groups associated with explosive properties present in the molecule of tripiperazine dicitrate.

Oxidising properties
The study does not need to be conducted because there are no chemical groups present in the molecule which are associated with oxidising properties and hence, the classification procedure does not need to be applied.

pH:
The pH determination of test item Tripiperazine dicitrate (CAS No. 144-29-6) was done following OECD guideline 122. pH of 1% w/v aqueous solution was measured with the help of pH meter/probe and it was observed to be 5.60 at 26.5 °C.

Viscosity:
In accordance with Section 2 of REACH Annex XI, information requirement section 7.17, this study cannot be conducted on solid materials or gases. According to ECHA Chapter 7 guidance, viscosity measurement is only relevant to liquids tripiperazine dicitrate is a white colored powder.Hence this study can be considered for waiver.

Additional information

Appearance/physical state/colour
The test chemical tripiperazine dicitrate was observed to be a white crystalline powder with faint odour.

Other supporting data from different sources like review article, handbook and MSDS also suggest that the chemical piperazine citrate is white colored crystalline/powder with characteristic odour.

Melting point/freezing point
The melting point determination of Test item Tripiperazine dicitrate (CAS No. 144-29-6) was done as per the test guideline OECD 102. The method followed was according to Capillary/metal block. The melting point range was found to be 180.3°C - 185°C at 977.0 hPa.

Other supporting studies from authoritative handbook and MSDS also suggest that the melting point of chemical piperazine citrate was 182 -187 degree C.

Boiling point
The boiling point determination of Test item Tripiperazine dicitrate (CAS No. 144-29-6) was done as per the test guideline OECD 103. The method followed was according to Siwoloboff. The test item started to boil and showed foam formation at 208 °C and colour changed from white to dark brown from 220 °C. Thus, the decomposition temperature was inferred to be 220°C at 976.5 hPa.

Density
The density of test item Tripiperazine dicitrate (CAS No. 144-29-6) was determined following OECD Guideline 109 and according to the International Pharmacopoeia, fourth Edition, 2014 using glass cylinder. The pour density and tapped density of Tripiperazine dicitrate (CAS No. 144-29-6) was determined to be 0.6458 gm/cm3 at and 0.7407 gm/cm3 at 28.3°C and 977.6 hPa.

Particle size distribution (Granulometry)
The particle size distribution of test item Tripiperazine dicitrate (CAS No. 144-29-6) was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was found to be in the range of 150 micron to 10 micron.

Vapour pressure
The vapor pressure of the test chemical was estimated using MPBPVP model from EPISUITE. The estimated vapor pressure of piperazine citrate was 56.928 Pa (0.427 mm Hg).

Partition coefficient
The octanol water partition coefficient of the test chemical was estimated using KOWWIN model from EPISUITE. The estimated logPow of piperazine citrate was -1.15. Based on this value, piperazine citrate can be considered to be hydrophillic in nature, which is also supported by the water solubility of the test chemical.

Water solubility
The water solubility determination of test item Tripiperazine dicitrate (CAS No. 144-29-6) was done as per the shake flask method. The solubility of Tripiperazine dicitrate in water was determined to be 540 g/L at 24 °C. This value indicates that the substance is very soluble in water.

Other supporting data from different handbooks also suggest Tripiperazine dicitrate to be very soluble in water.

Solubility in organic solvents:
As per the available data from different handbooks, Piperazine citrate was determined to be insoluble in alcohol, ether and chloroform.

Surface tension:
In accordance with column 2 of Annex VII of the REACH regulation, this end point was considered to be scientifically unjsutified for testing since surface activity is not a desired property of the material which is used predominantly in pharma application as an anti-helminthic.

Flash point:
The flash point determination of Tripiperazine dicitrate (CAS No. 144-29-6) was done following closed cup method using Pensky-Martens flash point apparatus. The observations were made till 200°C, burning smell was obtained but no flash was observed. Thus flash point was inferred to be greater than 200°C. The test was conducted in replicates and mean flash point was inferred to be greater than 200°C.

Auto flammability:
Tripiperazine dicitrate did not catch fire on being exposed to air at room temperature of 27°Cpressure of 966 hPa. This indicates that tripiperazine dicitrate is not auto-flammable.

Flammability:
Tripiperazine dicitrate does not indicate any ignition when the flame of bunsen burner having temperature of approximately 950°C is brought in contact with it. Thus it can be concluded that tripiperazine dicitrate is not flammable at high temperature. However since such high temperatures are not found under normal circumstances of transportation and use, thus tripiperazine dicitrate was considered non-flammable for chemical safety assessment.

Explosiveness
In accordance with column 2 of Annex VII of the REACH regulation, this end point was considered scientifically unjustified for testing, there are no chemical groups associated with explosive properties present in the molecule of Tripiperazine dicitrate.

Oxidising properties
The study does not need to be conducted because there are no chemical groups present in the molecule which are associated with oxidising properties and hence, the classification procedure does not need to be applied.

pH:
The pH determination of test item Tripiperazine dicitrate(CAS No. 144-29-6) was done as per the test guideline OECD 122. The pH of the test solution was determined with the help of pH probe. The measurement interface was Micro Lab FS-524; software version 6.2 8b. The pH was found to be 5.60 at 26.5°C.

Other supporting Data from Merck handbook also indicates the pH of 10% aqueous solution of Piperazine Citrate (144 -29 -6) to be 5 -6.

Viscosity:
In accordance with Section 2 of REACH Annex XI, information requirement section 7.17, this study cannot be conducted on solid materials or gases. According to ECHA Chapter 7 guidance, viscosity measurement is only relevant to liquids. tripiperazine dicitrate is a white colored powder. Hence this study can be considered for waiver.