Registration Dossier

Physical & Chemical properties

Endpoint summary

Administrative data

Description of key information

Appearance

Sodium salicylate was observed to be odourless white crystalline organic solid in appearance.

Melting point

The melting point determination of Test item Sodium salicylate (CAS No. 54-21-7 ) was done as per the test guideline OECD 102. The method followed was according to Capillary/metal block. The Mean Melting temperature range was found to be 208.5-213.5°C at 967.3 hPa.

Based on other supporting data from authoritative databases, the Melting point of sodium salicylate is determined to be 213 °C.

Other supporting data from authoritative database Gestis, also supported the selected key study and exhibited theMelting point of sodium salicylate as 200°C,closer to the selected key value.

Boiling point

The boiling point of chemical Sodium salicylate was determined to be 237 ˚C.

Density

The density of Test item Sodium salicylate (CAS No. 54-21-7 ) was determined following OECD guideline 109 and according to the method recommended in the International Pharmacopoeia, fourth Edition, 2014. The mean pour density and tapped density of the test item was found to be 0.5556 g/cm³ and 0.6156 g/cm³at 20 °C and 968.3 hPa.

 

Granulometry

The particle size distribution of test item Sodium salicylate (CAS No. 54-21-7 ) was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was found to be in the range of 150 micron to 25 micron.

 

Vapour pressure

The vapour pressure of sodium salicylate is estimated to be 4.9E-9 Pa (3.68E-11 mmHg) at 25 deg.C.  

 

Partition coefficient

The experimental value of octanol water partition co-efficient (log Pow) of sodium salicylate is -1.259 at 25 degC.This value indicates that sodium salicylate is hydrophilic in nature.

Water solubility

The water solubility determination of test item Sodium salicylate (CAS No. 54-21-7) was done as per the OECD guideline 105 byspectrophotometric analytical method as per OECD 101. The solubility of (Sodium salicylate of CAS No: 54-21-7 )in water was found to be 575.708 gm/L at 25°C.

Solubility in organic solvents

The Solubility of sodium salicylate in various organic solvents is determined as follows, in methanol determined as 206000 mg/L 25 degC and in petroleum ether determined as 1800 mg/L 25 degC.

 

Surface tension

In accordance with column 2 of Annex VII of the REACH regulation, the study need only be conducted if surface activity is a desired property of the chemical. The sodium salicylate is used frequently as a laboratory chemical, Synthesis of substances, etc. For this use, surface activity is not an important property. Hence this study was considered for waiver.

Flash point

The flash point determination of Test item Sodium salicylate (CAS No. 54-21-7 )was done. The method was closed cup method using Pensky-Martens Flash Point Apparatus. The meanflash point of the test item was found to be 98.3°C at 967.0 hPa.

Auto-flammability

The auto-ignition temperature (auto-flammability) of Sodium salicylate is determined to be greater than 250 °C.

Flammability

Sodium salicylate 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 Sodium salicylate is not flammable at high temperature. However since such high temperatures are not found under normal circumstances of transportation and use, thus Sodium salicylate was considered non-flammable for chemical safety assessment.

Explosiveness

According to theoretical considerations based on chemical structure, sodium salicylate does not possess explosive properties. The reason for this is there are no chemical groups associated with explosive properties in sodium salicylate.Thus,as per column 2 of Annex VII this endpoint was considered for waiver.

Oxidising properties

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

Stability in organic solvents and identity of relevant degradation products

This testing was not conducted since the stability of sodium salicylate in organic solvents is not considered to be critical. Moreover, sodium salicylate is very soluble in alcohol to the tune of 206000 mg/L at room temperature of 25 degC.Therefore this study was considered to be waived.

pH

The pH of Sodium salicylate was determined to be 6.85 at 26.3 °C .

Dissociation constant

The experimental pKa value for Sodium salicylate was found to be 0.00001 (1.0E-5) at 25 degC indicating that it has dissociation properties.

Viscosity

This end point was considered for waiver since viscosity is an internal property of a liquid that offers resistance to flow and Sodium salicylate is a solid substance and hence this testing was considered scientifically unjustified for Sodium salicylate.

Additional information

Appearance

Based on available data from handbooks and authoritative databases, the Sodium salicylate was observed to be odourless white crystalline organic solid in appearance.

Other supporting data from experimental report and secondary source, also supported the selected key study and observed the physical observation of sodium salicylate as a odourless white amorphous organic solid at 20°C and 1013 hPa.

Melting point

The melting point determination of Test item Sodium salicylate (CAS No. 54-21-7 ) was done as per the test guideline OECD 102. The method followed was according to Capillary/metal block. The Mean Melting temperature range was found to be 208.5-213.5°C at 967.3 hPa.

Based on other supporting data from authoritative databases, the Melting point of sodium salicylate is determined to be 213 °C.

Other supporting data from authoritative database Gestis, also supported the selected key study and exhibited theMelting point of sodium salicylate as 200°C,closer to the selected key value.

Other supporting data from authoritative database Gestis, also supported the selected key study and exhibited theMelting point of sodium salicylate as 200°C,closer to the selected key value.

Boiling point

Based on available data from obtained report, the boiling point of chemical Sodium salicylate was determined to be 237 ˚C

Density

The density of Test item Sodium salicylate (CAS No. 54-21-7 ) was determined following OECD guideline 109 and according to the method recommended in the International Pharmacopoeia, fourth Edition, 2014. The mean pour density and tapped density of the test item was found to be 0.5556 g/cm³ and 0.6156 g/cm³at 20 °C and 968.3 hPa.

Based on supporting data from authoritative database Gestis, the density of sodium salicylate was determined to be 0.32 g/cm³.

Other supporting data also determined the bulk density ofsodium salicylateby the mass by volume method as0.56g/cm3 at room temperature of 25 °C.

Granulometry

The particle size distribution of test item Sodium salicylate (CAS No. 54-21-7 ) was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was found to be in the range of 150 micron to 25 micron.

 

Vapour pressure

Based on available data from authoritative databases, estimated the vapour pressure of sodium salicylate as 4.9E-9 Pa (3.68E-11 mmHg) at 25 deg.C.  

 

Partition coefficient

The experimental value of octanol water partition co-efficient (log Pow) of sodium salicylate is -1.259 at 25 degC.This value indicates that sodium salicylate is hydrophilic in nature.

Water solubility

Based on experimental study report, the water solubility determination of test item Sodium salicylate (CAS No. 54-21-7) was done as per the OECD guideline 105 byspectrophotometric analytical method as per OECD 101. The solubility of (Sodium salicylate of CAS No: 54-21-7 )in water was found to be 575.708 gm/L at 25°C.

Based on available supporting data from authoritative database Gestis, the water solubility of sodium salicylate is determined to be 1000000 mg/l at 20 deg.C.

Other supporting studies from authoritative databases, handbook and experimental report, also supported the selected key study and exhibited the water solubility of sodium salicylate as 125000 mg/l, 119000 mg/l and 958600 mg/L at 25 degC respectively.

Hence on the basis of obtained values, the chemical sodium salicylate is considered to be very soluble in water.

Solubility in organic solvents

Based on available data from experimental report the Solubility of sodium salicylate in various organic solvents is determined as follows, in methanol determined as 206000 mg/L 25 degC and in petroleum ether determined as 1800 mg/L 25 degC.

Hence on the basis of obtained values the sodium salicylate is considered to be very soluble in methanol and soluble in petroleum ether.

 

Surface tension

In accordance with column 2 of Annex VII of the REACH regulation, the study need only be conducted if surface activity is a desired property of the chemical. The sodium salicylate is used frequently as a laboratory chemical, Synthesis of substances, etc. For this use, surface activity is not an important property. Hence this study was considered for waiver.

Flash point

The flash point determination of Test item Sodium salicylate (CAS No. 54-21-7 )was done. The method was closed cup method using Pensky-Martens Flash Point Apparatus. The meanflash point of the test item was found to be 98.3°C at 967.0 hPa.

Based on the calculation done using  scientifically verified and validated formulas / equations, the flash point of chemical Sodium salicylate was estimated to be 97.24 degree C.

Thus, according to flash point value the chemical Sodium salicylate was not classified as flammable.

Auto-flammability

Based on available data from authoritative database Gestis, the auto-ignition temperature (auto-flammability) of Sodium salicylate is determined to be greater than 250 °C.

Flammability

Sodium salicylate 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 Sodium salicylate is not flammable at high temperature. However since such high temperatures are not found under normal circumstances of transportation and use, thus Sodium salicylate was considered non-flammable for chemical safety assessment.

Explosiveness

According to theoretical considerations based on chemical structure, sodium salicylate does not possess explosive properties. The reason for this is there are no chemical groups associated with explosive properties in sodium salicylate.Thus,as per column 2 of Annex VII this endpoint was considered for waiver.

Oxidising properties

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

Stability in organic solvents and identity of relevant degradation products

This testing was not conducted since the stability of sodium salicylate in organic solvents is not considered to be critical. Moreover, sodium salicylate is very soluble in alcohol to the tune of 206000 mg/L at room temperature of 25 degC.Therefore this study was considered to be waived.

pH

The pH determination of test item Sodium salicylate (CAS No. 54-21-7 ) was done as per the test guideline OECD 122. The mean pH of the test solutionwas determined with the help of digital pH meter. The mean pH was found to be6.85at26.3 °C.

Based on available data from publication and authoritative database Gestis, the pH of Sodium salicylate was determined to be 6.5 at 20 °C and at concentration 100 g/l. Thus, pH of 100 g/l of Sodium salicylate at 20 °C considered to beslightly acidic in nature.

Other supporting data from experimental report also supported the selected key study and exhibited, pH of1% by volume solution of Sodium salicylate as 6.21 at 27 degC. Thus 1% by volume solution of Sodium salicylate is slightly acidic in nature.

Dissociation constant

The experimental pKa value for Sodium salicylate was found to be 0.00001 (1.0E-5) at 25 degC indicating that it has dissociation properties.

Viscosity

This end point was considered for waiver since viscosity is an internal property of a liquid that offers resistance to flow and Sodium salicylate is a solid substance and hence this testing was considered scientifically unjustified for Sodium salicylate.