Registration Dossier
Registration Dossier
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EC number: 208-993-4 | CAS number: 551-16-6
Endpoint summary
Administrative data
Description of key information
Additional information
Appearance/ Physical state:
In Fox and White 2010, the test material was described as an off white powder at room temperature.
Melting Point:
The melting point of 6-aminopenicillanic acid was evaluated using standard melting point apparatus in Gilmore 2006 and was found that onset of decomposition occurred at: 196 °C.
Boiling Point:
The boiling point of 6-Aminopenicillanic acid was calculated by the EU method A2 and the an adaptation of the Stein and Brown Method MPBPWIN version 1.43, ©2000 US Environmental Protection Agency in the report by Fox and White 2010.The boiling point was determined to be 699 K at Atmospheric pressure: 99.36 kPa.
Density:
The density of ampicillin was stated to be 1.37 g/mL at ambient temperature.
Particle Size Distribution (Granulometry):
The particle size of 6-aminopenicillanic acid was determined by the OECD method 110 in the study by Fox and White 2010.
97.6 % of the particles were < 100 µm (inhalable) from the sieve method, 2.58 % were < 10.0 µm (thoracic) from the cascade impactor results and 0.975% were <5.5 µm (respirable) also from the cascade impactor results.
Vapour Pressure:
The vapour pressure of 6-aminopenicillanic acid was determined using the EU method A4 in the study by Fox and White 2010.
The vapour pressure of 6 -aminopenicillanic acid was determined to be <0.000377 Pa at 25 °C.
Partition coefficient:
The partition coefficient of 6-aminopenicillanic acid was determined using the EU method A8 in the study by Fox and White 2010.The Log Kow (Log Pow) was -3.87 at the temperature of 22.5°C.
Water Solubility:
The water solubility of 6-aminopenicillanic acid was determined using the EU method A6 in the study by Fox and White 2010.The water solubility was 2.46 g/L at the temperature of 22.5°C, which was determined to be soluble.
Surface Tension:
According to Annex VII, Section 7.6, Column 2 of Regulation No. 1907/2006, a surface tension study need only be conducted if based on structure, surface activity is expected or can be predicted. Or, if surface activity is a desired property of the material. 6-aminopenicillanic acid meets neither of these criteria.
Flash Point:
The test procedure, EU Method A.9 (Flash-Point), is applicable to liquid substances whose vapours can be ignited by ignition sources. As 6-aminopenicillanic acid is a solid, it does not fall under the scope of the test.
Auto Flammability:
The auto-flammability of 6-aminopenicillanic acid was studied in Gilmore 2006.No ignition or exotherm was observed up to 400 °C.
Flammability:
The flammability of 6-aminopenicillanic acid was investigated using a method equivalent to EU method A10 in the study by Gilmore 2006. 6 -Aminopenicillanic acid was determined to be non-flammable.
Oxidising Properties:
The study does not need to be conducted if:
- the substance is incapable of reacting exothermically with combustible materials, for example on the basis of the chemical structure (e.g. organic substances not containing oxygen or halogen atoms and these elements are not chemically bonded to nitrogen or oxygen, or inorganic substances not containing oxygen or halogen atoms.
6-APA does not contain any halogen atoms and therefore does not contain any halogen atoms chemically bonded to nitrogen or oxygen.
Stability in organic solvents and identity of relevant degradation products:
The stability of the test material in organic solvents was measured by HPLC analysis in the study by Fox and White 2010.
The test material was determined to be unstable in methanol with the rate constant and half-life at 25°C being 2.84 x 10-3 hour-1 and 10.2 days respectively.
pH:
The pH of 6-Aminopenicillanic acid was measured with a HI 9024 portable pH metre with a temperature probe. The pH of a 10% aqueous solution of 6-Aminopenicillanic acid was 3.4.
Dissociation constant:
According to Annex IX, Column 2, Section 7.16: The study does not need to be conducted if:
-The substance is hydrolytically unstable (half-life less than 12 hours).
-Readily oxidisable in water.
6-aminopenicillanic acid was determined to have a half life of 4.68 hours at the physiologically relevant pH of 1.2 at 37 °C
Viscosity:
Viscosity was not determied as the test material is a solid.
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