Registration Dossier
Registration Dossier
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EC number: 228-783-6 | CAS number: 6358-69-6
Endpoint summary
Administrative data
Description of key information
Appearance:
On the basis of physical observation, test substance was observed to be a yellow colored powder.
Melting point:
The melting point determination of test chemical was done following OECD 102 and according to the method of Capillary/metal block.The test item starts decomposing at 252°C with colour change from yellow to green and turns black at 258.5 °C.The test was conducted in replicates and mean decomposition range was determine to be 252°C -258.5 °C at 972.7 hPa.
Boiling Point:
The study does not need to be conducted because the substance is a solid which decomposes before boiling. According to Column II of Annex VII, the boiling point study does not need to be conducted for solids which either melt above 300 °C or decompose before boiling. Test substance is a solid at room temperature and it is starts to decompose at a temperature of 252 °C and complete decompostion at 258.5 °C .Hence, it is not feasible to determine boiling point and the endpoint was considered for waiver.
Density:
The density of test item was determined following OECD guideline 109 and according to the method recommended in the International Pharmacopoeia, fourth Edition, 2014. The pour density and tapped density of the test item was determine to be 0.5718 g/cm3and 0.7151 g/cm3at 32.2oC and 974.6hPa.
Particle size distribution:
The particle size distribution of test item was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was determine to be in the range of 150 micron to 25 micron. Thus, it is concluded that the majority of the particle size of the chemical is is not in the inhalable size which is less than 10 microns.
Vapour pressure:
The estimated vapour pressure of test substance at 25 deg C was 2.47E-23 Pa.
Partition coefficient:
Based on the available data modelling database, KOWWIN V1.68 was used to estimate the octanol water partition coefficient of the test chemical. The estimated logPOW of the test chemical was estimated to be -3.97. Based on the estimated value, test chemical can be considered to be hydrophilic in nature.
Water solubility:
The water solubility determination of test item was done gravimetrically as per the shake flask method using membrane filtration assembly followed by air drying.The water solubility was determine to be 271.25 g/L at 31°C.
From above water solubility value it is concluded that test chemical is very soluble in water.
Surface tension:
In accordance with column 2 of Annex VII of the REACH regulation, this testing needs to be carried out only if surface activity is a desired property of the chemical. Test chemical is used as a personal care and home care color. For these uses, surface activity is not a desired property and hence this end point was considered for waiver.
Flash point:
The flash point determination of Test item was done. The method is closed cup method using Pensky-Martens Flash Point Apparatus. The mean flashpoint of the test item was exprimentally determined to be 249.6°C at 974.4 hPa.
Auto flammability:
Test chemical did not catch fire on being exposed to air at room temperature of 27°C pressure of 966 hPa. This indicates that Test chemical is not auto-flammable.
Flammability:
Test chemical 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 Test chemical is not flammable at high temperature. However since such high temperatures are not found under normal circumstances of transportation and use, thus Test chemical was considered non-flammable.
Explosiveness:
In accordance with column 2 of Annex VII of the REACH regulation, the study is scientifically unjustified since there are no chemical groups associated with explosive properties present in the molecule of test chemical. Thus, the chemical is not likely to be explosive.
Oxidizing properties:
In accordance with column 2 of Annex VII of the REACH regulation, test substance is incapable of reacting exothermically with combustible materials,on the basis of the chemical structure. It is an organic substance not containing halogen atoms but it contains oxygen atoms and these elements are not chemically bonded to nitrogen or oxygen. THus, the chemical is unlikely to exhibit oxidising properties and this study was therefore cnsidered for waiver.
pH:
The pH of 1% w/v aqueous solution of the test item was 5.32 at 31.6°C indicating that the chemical is moderately acidic.
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. Test chemcial is a yellow colored powder. Hence this study was considered for waiver.
Additional information
Appearance:
On the basis of physical observation, test substance was observed to be a yellow colored powder.
Available data suggests that test chemical is Bright yellow-green/bright green powder.
Melting point:
The melting point determination of test chemical was done following OECD 102 and according to the method of Capillary/metal block.The test item starts decomposing at 252°C with colour change from yellow to green and turns black at 258.5 °C.The test was conducted in replicates and mean decomposition range was determine to be 252°C -258.5 °C at 972.7 hPa.
Boiling Point:
The study does not need to be conducted because the substance is a solid which decomposes before boiling. According to Column II of Annex VII, the boiling point study does not need to be conducted for solids which either melt above 300 °C or decompose before boiling. Test substance is a solid at room temperature and it is starts to decompose at a temperature of 252 °C and complete decompostion at 258.5 °C .Hence, it is not feasible to determine boiling point and the endpoint was considered for waiver.
Density:
The density of test item was determined following OECD guideline 109 and according to the method recommended in the International Pharmacopoeia, fourth Edition, 2014. The pour density and tapped density of the test item was determine to be 0.5718 g/cm3and 0.7151 g/cm3at 32.2oC and 974.6hPa.
Particle size distribution:
The particle size distribution of test item was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was determine to be in the range of 150 micron to 25 micron. Thus, it is concluded that the majority of the particle size of the chemical is is not in the inhalable size which is less than 10 microns.
Vapour pressure:
Modified Grain method was used to estimate the vapour pressure of the test substance using MPBPVP v1.43 of EPI SUITE.
The estimated vapour pressure of test substance at 25 deg C was 2.47E-23 Pa.
Partition coefficient:
Based on the available data in a key study from modelling database, KOWWIN V1.68 was used to estimate the octanol water partition coefficient of the test chemical. The estimated logPOW of the test chemical was estimated to be -3.97.
Additional studyfromauthoritative and modelling databasesindicates that the octanol water partition coefficient (log Pow) value of the test chemical was estimated to be -0.68
Thus, based on the available information, the logPow value of the test chemical ranges from -3.97 to -0.68, respectively. On the basis of this value, test chemical can be considered to be hydrophilic in nature.
Water solubility:
The water solubility determination of test item was done gravimetrically as per the shake flask method using membrane filtration assembly followed by air drying.The water solubility was determine to be 271.25 g/L at 31°C.
From above water solubility value it is concluded that test chemical is very soluble in water.
From other reliable sources & authoritative databases it is concluded that chemcial is very soluble in water.
Surface tension:
In accordance with column 2 of Annex VII of the REACH regulation, this testing needs to be carried out only if surface activity is a desired property of the chemical. Test chemical is used as a personal care and home care color. For these uses, surface activity is not a desired property and hence this end point was considered for waiver.
Flash point:
The flash point determination of Test item was done. The method is closed cup method using Pensky-Martens Flash Point Apparatus. The mean flashpoint of the test item was exprimentally determined to be 249.6°C at 974.4 hPa.
From other reliable sources flash point of the test chemical is greater than 93.333°C.
Auto flammability:
Test chemical did not catch fire on being exposed to air at room temperature of 27°C pressure of 966 hPa. This indicates that Test chemical is not auto-flammable.
Flammability:
Test chemical 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 Test chemical is not flammable at high temperature. However since such high temperatures are not found under normal circumstances of transportation and use, thus Test chemical was considered non-flammable.
Explosiveness:
In accordance with column 2 of Annex VII of the REACH regulation, the study is scientifically unjustified since there are no chemical groups associated with explosive properties present in the molecule of test chemical. Thus, the chemical is not likely to be explosive.
Oxidizing properties:
In accordance with column 2 of Annex VII of the REACH regulation, test substance is incapable of reacting exothermically with combustible materials,on the basis of the chemical structure. It is an organic substance not containing halogen atoms but it contains oxygen atoms and these elements are not chemically bonded to nitrogen or oxygen. THus, the chemical is unlikely to exhibit oxidising properties and this study was therefore cnsidered for waiver.
pH:
The pH of 1% w/v aqueous solution of the test item was 5.32 at 31.6°C indicating that the chemical is moderately acidic.
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. Test chemcial is a yellow colored powder. Hence this study was considered for waiver.
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