Registration Dossier
Registration Dossier
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EC number: 916-899-6 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
There are no experimental toxicokinetic data available for the substance and this statement is based on the available physico-chemical and toxicological data. This comprises inter alia studies on skin irritation/corrosion, eye irritation, skin sensitization, in vitro mutagenicity and acute and repeated dose oral toxicity. The assumption on toxicokinetics follows the procedure indicated in the “Guidance on information requirements and chemical safety assessment chapter R.7c” of the ECHA guidance document (version 3.0, June 2017).
Available physico-chemical information taken into account:
Physical appearance: Bayscript Blaukomonente TEA-Salz is a brown-violet, crystalline solid at 20°C and 1013 hPa.
Boiling point: Decomposition of the substance is observable at around 140°C. Therefore no boiling point could be determined.
Particle size distribution: No data available
Molecular weight range: 871 - 1031 g/mol (UVCB)
Water solubility: Highly soluble (> 841.7 g/L at 20°C)
Log Pow: The partition coefficient was estimated with ≤ 0 due to the high solubility and by comparison with similar substances. Thus, the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum.
Vapor pressure: Anticipated to be low and estimated by QSAR for the three main components to be 0 Pa at 25 °C.
Estimation of oral absorption: Oral absorption can be assumed, based on the physico-chemical properties (soluble in water, log Pow for the three main components in the range of favourable for absorption). In the subchronic repeated dose toxicity study (OECD TG 408) and in the Reproductive/Developmental Toxicity Screening Study (OECD TG 422) the body and several organs of animals treated with 1000 mg/kg bw/day appeared discoloured, due to staining with the test item (dye). Coloured kidneys were observed starting at 100 mg/kg bw indicating the UVCB substance is already absorbed at this dose. This is further evidenced by purple/blue stained urine noticed after acute and repeated oral dosing of 300 mg/kg bw and above.
Overall: oral absorption is proven based on physicochemical properties and toxicological studies with oral exposure.
Estimation of dermal absorption: Dermal absorption is unlikely based on log Pow of ≤ 0, the high water solubility, and the relatively high molecular weight.
Other parameters relevant for dermal absorption: The substance is not irritating to the skin, thus it does not affect the skin barrier. However, dermal uptake could be demonstrated in a skin sensitization study (LLNA, OECD TG 429) in which the substance showed a moderate sensitizing potential.
Estimation of absorption via inhalation: Vapor pressure is anticipated to be low and estimated by QSAR for the three main components to be negligible at 25 °C; no information on particle size distribution is available. No acute inhalation toxicity study is available to estimate potential absorption.
Overall: absorption by inhalation of aerosol or dust might be assumed but vapor pressure is low.
Overall estimation of absorption: Some absorption is anticipated by oral, dermal and inhalation route.
Estimation of distribution: Based on the log Pow ≤ 0 and the high water solubility it is likely that the substance will distribute in the body after being systemically available. This assumption is supported by the available repeated dose oral toxicity studies in which the whole body and several organs of animals treated with 1000 mg/kg bw/day appeared discoloured. Coloured kidneys were observed starting at 100 mg/kg bw indicating the UVCB substance is distributed into kidneys at this dose.
Estimation of accumulation: In general highly water soluble particles have a low potential to accumulate in tissue.
Estimation of metabolism: In vitro genotoxicity data do not indicate the generation of DNA-reactive metabolites due to hepatic biotransformation, since the substance revealed negative results in the available in vitro genotoxicity tests (Ames test on the substance; HPRT and MNT in vitro via read-across), conducted in the absence and in the presence of a metabolizing system.
Estimation of excretion:
Purple/blue stained urine and blue/purple/black stained feces were noted after a single dose of 300 and 2000 mg active ingredient/ kg bw (OECD TG 420), demonstrating that excretion via urine is possible. Furthermore, the kidney as the primary target organ in repeated dose oral toxicity studies suggest a renal excretion pathway.
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