Registration Dossier
Registration Dossier
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EC number: 249-171-5 | CAS number: 28706-25-4
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Since no toxicokinetic studies are available for Direct Red 239 the following assessment is based on the available physicochemical properties and results from toxicological studies.
1) UPTAKE
Oral:
The substance is a black powder with a molecular weight of 1060.87954 g/mol. The calculated log Pow value is -4.2 at 23°C and the calculated solubility in water is 218 g/L at 20°C. The substance’s high water solubility and its high molecular weight (> 1000 g/mol) limit its absorption by the gastro-intestinal tract. Furthermore, the results of the study on reproduction toxicity with Direct Red 239 (BASF SE, 2013), in which the test substance was administered by oral gavage, revealed no systemic effects in any of the treated animals. Red colored feces however, were noted in all treatment groups. The severity of the red coloration increased with increasing dose level. This suggests incomplete absorption through the GI tract.
Inhalation:
No experimental data is available concerning the respiratory hazard of Direct Red 239. The particle size distribution of the test substance, as measured by laser diffraction, indicates that 16% is inhalable (particle size < 100µm), about 23% can be defined as the thoracic fraction, the mass fraction that can pass the larynx (particle size < 10µm), and 0.1% of the particles can reach the alveoli (particle size < 4µm) (BASF SE, 2011). Though the substance is highly hydrophilic, its high molecular weight limits absorption through aqueous pores. Further, for highly hydrophilic substances uptake may be limited by the low rate at which they partition out of the mucus and into the blood. It is more likely that inhaled Direct Red 239 is retained in the mucus and transported out of the respiratory tract. Overall it is expected that the substance is not readily absorbed by inhalation.
Dermal:
The low log Pow (-4.2), the high molecular weight and the high water solubility (> 10000 mg/L) suggest that the substance may be too big and too hydrophilic to cross the lipid rich environment of the stratum corneum. Dermal uptake for such substances will be low. In addition, as the substance is not a skin irritant (Ciba-Geigy Ltd., 1981) and has no sensitising properties (Research and Consulting Company AG (RCC), 1990) the dermal uptake of the test compound will be low. In the available acute dermal study no systemic effects were observed (Lea Jehlickova and Viktor Mejstrik, 1995), further strengthening the conclusion that dermal absorption for Direct Red 239 will be low.
2) DISTRIBUTION
No specific statement can be made regarding the distribution of Direct Red 239 in organisms. The available in vivo studies provided no evidence of distribution as no systemic effect or coloration of internal organs was observed. Its high molecular weight and high water solubility would limit diffusion of the substance through aqueous channels/pores and membranes, respectively.
3) ACCUMULATION
No specific statement can be made regarding tissue accumulation of Direct Red 239. The available in vivo studies provided no evidence of accumulation as no systemic effect or coloration of internal organs was observed. The physicochemical properties of Direct Red 239 suggest that its bioaccumulation once taken up will be low.
4) METABOLISM
Based on the chemical structure of Direct Red 239 (Kolliget al. (1993), Boethling & Mackay (2000) and Harris (1990)) it is not expected that it is hydrolyzed in the GI-tract as it does not contain any functional groups sensitive to hydrolysis. It is not known whether Direct Red 239 is metabolized by intestinal flora or in tissues. The results of in vitro mutagenicity (Ames) tests with Direct Red 239 did not indicate formation of genotoxic or cytotoxic metabolite(s) in the presence of metabolic activation (hepatic S9 mix).
5) EXCRETION
Due to its low absorption, Direct Red 239 will largely leave the body via the faeces following oral exposure. It is not known how Direct Red 239 is excreted once absorbed. Its high molecular weight does not favour excretion via the urine.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.
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