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EC number: 251-156-3 | CAS number: 32687-78-8
There were no studies available in which the toxicokinetic properties of the test substance were investigated.
The test substance (molecular weight of 552.79 g/mol) is a white solid with a log Pow of 4.8, a water solubility < 0.05 mg/L, and a vapor pressure of 1.3 E-10 Pa at 20°C (estimated).
The low water solubility does not support ready dissolving in gastric fluids, suggesting a low absorption potential after oral ingestion. This is also supported by the available oral toxicity data obtained in rats. In an acute toxicity study, no mortality was reported up to the maximum dose level administered (7000 mg/kg bw) with the observation of commonly occurring clinical signs (dyspnoea, exophthalmus, diarrhea, ruffled fur and curved body position). No indications for systemic toxicity could be detected. In a 90-day repeated dose toxicity study no mortality and no relevant treatment-related findings were observed, indicating poor systemic distribution of the test substance.
In a guinea pig maximization and a guinea pig optimization assay, no indications of systemic availability after dermal application were detected. This is in line with the predictions made based on the physico-chemical parameters. According to ECHA guidance document Chapter R7c, molecules with a molecular size larger than 500 and with a log Pow greater than 4, skin penetration is expected to be low. In conclusion, a dermal uptake of the test substance is expected to be low.
Based on the low vapor pressure exposure to vapors can be excluded. Upon inhalation of dusty material, the particles have the potential to be inhaled (< 100 µm) and are supposed to reach alveolar region of the respiratory tract (ECHA GD 7c, 2008). Dust particles are expected to be poorly absorbed based on the low water solubility and removed by clearing mechanisms. The compound may be taken up by micellular solubilisation, a mechanism of importance for highly lipophilic compounds (log P > 4), particularly for those that are poorly soluble in water (1 mg/l or less) that would otherwise be poorly absorbed (ECHA GD 7c, 2008).
Using the OECD toolbox 3.0, the liver metabolism simulator predicted hydroxylation of the alkyl side chain and the aromatic ring. Furthermore, metabolites were proposed where the amide bond was hydrolyzed. Studies on genotoxicity (Ames-Test, micronucleus assay in-vivo) showed no increased mutagenicity or cytotoxicity in treatments with metabolic activation, indicating that the pigment is not converted into toxic or genotoxic metabolites.
Some potential metabolites as well as the parent chemical have a molecular weight a little higher than 300 g/mol and were considered insoluble in water. Thus, they are expected to be excreted predominantly via the feces (ECHA GD 7c, 2008). Some potential metabolites have a molecular weight lower than 300 g/mol, and thus are expected to be excreted predominantly via the urine (ECHA GD 7c, 2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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