Registration Dossier

Physical & Chemical properties

Endpoint summary

Administrative data

Description of key information

Additional information

Appearance/physical state

Test item is a white powder at 20 °C and 1013 hPa. There is no hazard associated with the physical state. However, the test item is produced in-situ, i.e. diluted in a solvent, and does not exist in its solid form. It is produced and used in its dissolved form and, hence, there is no chance of inhalative exposure to particles of the test item during the entiry life cycle. A more detailed assessment regarding inhalative hazards is given below.

Boiling point

As the test item decomposes before boiling, the boiling point cannot be determined. There is no hazard resulting from decomposition of the test item before boiling.

Particle size distribution

Results are summarised in the following table.

Percentile Mean St. dev. Remarks
D10 ca. 7.82 µm 0.157
D50 ca. 33.23 µm 0.395
D90 ca. 66.82 µm 1.178

Since the biggest part of all particles with a diameter of about 0.5 -5 µm is deposited in the nasal cavity and laryngeal region of the respiratory tract of humans1), most of the test item particles are not able to penetrate deep into the alveolar regions. Clearance of inhaled particles, if any, predominantly takes place by mucocilia transport. Due to the fact that the test item did not show any signs of toxicity in any toxicity study performed, acute oral toxicity as well as repeated dose toxicity, it can be cloncluded that the clearance of inhaled particles, if any, via the gastro-intestinal route does not pose any hazard to human health. Therefore, the particle size distribution does not result in any hazard.

Moreover, the test item is produced in-situ, i.e. diluted in a solvent, and does not exist in its solid form. It is produced and used in its dissolved form and, hence, there is no chance of inhalative exposure to particles of the test item during the entiry life cycle.

1): Marquardt, Schäfer, "Lehrbuch der Toxikologie", 2. Auflage, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, Germany

Vapour pressure

The vapour pressure of the test substance was determined to be < 2.35 x 10EXP-24 Pa, i.e. extremely low. Since volatilisation of the substance is a function of its vapour pressure, it can be concluded that the test item will not become airborne under any conditions relevant for its production and use durings its entire life cycle. As a consequence, no relevant release into the atmosphere will take place. Moreover, exposure via the inhalative route will not occur for both workers as well as consumer.

Partition coefficient

The high LogPow values estimated reflect the extreme low water solubility of the test item. Since the reason for the high Log Pow is the poor water solubility, Log Pow cannot be directly associated with a high lipophilicity and hence a possible tendency to bioaccumulate of the test item. Further details on bioavailability

Water solubility

The fact that the test item is insoluble has direct effects on (i) the n-octanol/water partition coefficient (Log Pow), (ii) biodegradation, and (iii) adsorption properties as detailed in IUCLID5 sections 4.7, 5.2.1, and 5.4.1, respectively.

n-octanol/water partition coefficient (IUCLID5 section 4.7):

The Log Pow determined is between 12 and 16, i.e. extremely high, reflecting the inability of the test item to dissolve in water.

Biodegradation (IUCLID5 section 5.2.1):

The test item is not biodegradable due to the fact that it is not dissolved in water and, as a consequence, not bioavailable for microorganisms. The fact that the test item is not bioavailable is also supported by the results of the toxicological studies performed, as summarised in the toxicokinetic assessment (cf. IUCLID5 section 7.1.1).

Adsorption/desorption (IUCLID5 section 5.4.1):

The adsorption coefficient was determined to be > 10, reflecting the tendency of the test item to avoid any aqueous environment.

Auto-flammability

The test item does not give rise to any concern related to auto-flammability. Neither did the study results indicate any hazard nor does the molecule contain any structural alerts with respect to pyrophoricity, explosive and oxidising properties.

Flammability

The test item does not give rise to any concern related to flammability. Neither did the study results indicate any hazard nor does the molecule contain any structural alerts with respect to pyrophoricity, explosive and oxidising properties. The test item does is not self-heating nor does it react with water or air. Practical experience from production and use do not give rise to any concern related to physical-chemical hazards.

Explosiveness

The appraisal of the composition and the molecular structure indicates without doubt, that the reactive groups in the structural formula of the substance could not lead to the conclusion, that the substance is capable of a rapid decomposition or reaction with a strong release of heat. This result was confirmed in analogy and extrapolation from data existing for comparable components. Moreover, practical experience from production and use do not give rise to any concern related to physical-chemical hazards.

Oxidising properties

The test substance does not have the functional groups associated with oxidising activity. It has never demonstrated such activity under normal handling. The oxygen balance of the test substance is negative. This means, there is a surplus on carbon atoms.

Therefore, it can be concluded beyond reasonable doubt that the test substance is incapable of causing fire or enhance the risk of fire when in contact with combustible material.