Registration Dossier
Registration Dossier
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EC number: 259-571-1 | CAS number: 55290-62-5
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Assessment of the Toxicokinetic Behavior
The test substance is a yellow, grained powder with a density of 1218 kg/m³ at 20°C and a molecular weight of 501.6 g/mol. The vapor pressure was estimated to be <0.00001 Pa at 25°C. The test item is furthermore characterized by very low solubility in water (0.8 µg/L at 20°C at pH 6.7). The log Pow was determined by HPLC method and gave a result of 5.7 at 23°C at pH 5.9. No studies are available investigating the toxicokinetic properties of the test substance. The toxicokinetic behavior is therefore assessed based on physic-chemical properties and on available toxicity studies performed with the test article.
Absorption
In an acute toxicity study in rats no mortality and no systemic findings were observed after oral administration of test substance (Safepharm, 2000). Therefore no indications are given that the substance is taken up after oral administration. Generally the smaller the molecule, the more easily it may be taken up. Molecular weights below 500 g/mol are favorable for absorption; molecular weights above 1000 g/mol do not favor absorption (ECHA GD 7c, 2008). Based on molecular weight the test substance could be absorbed in the gastrointestinal tract. However, the water solubility of the test article is very low, thus not favoring the substance to be readily dissolved in gastrointestinal fluids. Furthermore, passive diffusion is also not very likely to happen because of the high log P (> 4) of the test substance. Based on these physico-chemical parameters, the potential for absorption through the gastrointestinal tract is considered to be low but cannot be entirely be ruled out. In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (BASF, 2015), no toxicological relevant effects were reported up to the highest dose tested (750 mg/kg). No indications of systemic availability could be obtained in this study. The observation of colored feces indicates that the substance is excreted unchanged. Accumulation of the test article in the body is therefore not expected.
Dermal absorption is equally unlikely based on the test compound’s physical properties. According to ECHA guidance chapter 7c, dermal absorption does not exceed 10% if the molecular weight is > 500 and the log Pow is outside the range of -1 to 4, which is the case for the test article. In a dermal toxicity study no signs of toxicity were observed with the limit dose of 2000 mg/kg, indicating a low systemic availability after dermal exposure (Bioassay, 2014). In conclusion, based on the physico-chemical properties together with the results of acute dermal toxicity studies, dermal absorption of the test article is expected to be low.
No data from acute or repeated dose inhalation toxicity studies are available, which could provide information about the systemic distribution of the test substance after inhalation. Inhalative exposure to vapors is not of relevance as the substance has a very low vapor pressure (<0.00001 Pa at 25°C). Particle size distribution analysis demonstrated that no particles are smaller than 100 µm with an MMD of 1088µm. These data demonstrate that the particles will not reach the alveolar region. Particles deposited in the nasopharyngeal region will most likely be coughed or sneezed out and particles deposited in the trachea-bronchial region will be cleared by mucocilliary mechanisms and swallowed.
Metabolism
Due to the low absorption the substance is most likely excreted unchanged. This is supported by the observation of colored feces in the repeated dose toxicity study. The substance was tested negative in various genotoxicity tests, i.e. there is no indication of a reactivity of the test substance or its metabolites with biomacromolecules under the chosen test conditions.
Excretion
The excretion pathway is largely dependent on molecular size, polarity and water solubility. Therefore, the parent compound is expected to be excreted mainly via feces. This is in line with the discolored feces observed in the repeated dose study.
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