Registration Dossier
Registration Dossier
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EC number: 300-504-3 | CAS number: 93941-05-0
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
INTRODUCTION
In accordance with the Section 8.8.1 of Annex VIII in Regulation (EC) No 1272/2008, the toxicokinetic profile of the substance was derived from all available substance-specific information as collated in the registration dossier. The assessment is based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, 2017).
PHYSICOCHEMICAL PROPERTIES
C.I. Reactive Red 3:1 is a mono-constituent substance with a molecular weight of 788.0714 g/mol. It is a brown powder with a meting point of above 400 °C. Therefore, the vapour pressure of the registered substance is considered to be very low. The registered substance has a very high water solubility of 275 g/L at 20 °C with a low log Pow value of ≤ -4.4827 at 25 °C. Due to its very high water solubility and the logPow value, the registered substance is expected to be readily dissociated into the gastro-intestinal fluids for oral absorption by passive diffusion. The dermal absorption is expected to be low due to its relatively high molecular weight with very hydrophilic property. Particles of the registered substance are expected to be deposited in the nasopharyngeal/thoracic region with limited absorption via the inhalation route. The particles may be cleared from the airways by the mucocilliary mechanism and eventually swallowed.
ABSORPTION
Signs of oral absorption are seen in the results of the 14-day range-finding study and combined repeated dose and reproduction/developmental toxicity test in rats (Miyata, 2020a,b), both of which were conducted via oral gavage.
Dermal toxicity studies were waived for the registered substance, due to the low acute oral toxicity and a lack of skin irritation and sensitisation properties. The registered substance is not a skin or eye irritant. Therefore, there is no indication that the dermal absorption may be enhanced by a repeated dosing regimen. There are no signs of dermal absorption of the registered substance from the negative results in the two guinea pig maximisation tests (Driscoll, 1994; Tsai, 2016a). A limited dermal absorption is also supported by thehigh molecular weight and very hydrophilic property of the registered substance.
There are no in vivo mammalian studies available via the inhalation route for the registered substance. However, due to its physico-chemical properties, inhalation is not considered to be the most significant route of exposure.
DISTRIBUTION
Distribution and accumulation of the registered substance to the kidneys are evidencedby vacuolisation of the proximal tubules with brown pigment deposition in the cortexin the rat in the OECD 422 study (Miyata, 2020b). However, wider distribution of the registered substance may be limited due to the relatively large molecular size with very hydrophilic properties. Due to its low log Pow value, the registered substance is not expected to be accumulated in body fat.
METABOLISM
The available OECD 422 study show no evidence of enhanced metabolism (Miyata, 2020b). The results of the in vitro genotoxicity assays do not show any evidence that the addition of the S9 metabolising system either enhances or diminishes the activity of the registered substance (Furukama, 2019, 2020; Taniguchi and Munemitsu, 1995; Tsai, 2016b).
EXCRETION
There is no evidence to indicate the route of excretion. However, the kidney is expected to be a significant route of excretion for substances with high water solubility. Urinary excretion of the registered substance is evidenced by the reddish urine associated with the colour of the test substance observed in all treatment groups in the OECD 422 study in rats (Miyata, 2020b). Any test material that is not absorbed will be excreted in the faeces.
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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