Registration Dossier
Registration Dossier
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EC number: 614-503-3 | CAS number: 68441-62-3
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Based on its water-solubility and the systemic effects observed in rats upon acute and subchronic oral exposure and subacute inhalation exposure, Polyol IXOL B350 is expected to be absorbed by the gastrointestinal and respiratory tract. In the absence of substance-specific data, a default absorption value of 100% is assumed for the inhalation and oral route. For the dermal route, a default (worst case) absorption value of 100% is also assumed.
Key value for chemical safety assessment
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
No data are available that describe the toxicokinetics of Polyol IXOL B350, therefore relevant substance properties and data from toxicity studies indicating systemic bioavailability were taken together to assess the general toxicokinetics of the substance.
Polyol IXOL B350 (molecular weight range of 319-775 g/mol) is a dark brown viscous liquid (viscosity: 48560 mPa.s) with a measured vapour pressure of 0.0655 Pa at 20°C, an octanol-water partition coefficient (log Kow) of -0.03-3.3 at 25 °C and the water solubility of the substance is 4.4 g/L.
Oral and respiratory absorption
The available acute oral toxicity (dose levels: 625, 1250, 2500 and 5000 mg/kg bw) revealed effects which may indicate systemic availability of the substance. Clinical signs were mainly indicative of an effect on the autonomic nervous system, on the central nervous system, on motor coordination and on muscle tone. Autopsy of the rats that died as a result of treatment revealed effects on kidneys (pale), liver (pale), lymph nodes (congested) and lungs (red spots). Systemic effects were also observed in an Extended One Generation Toxicity Study that was conducted with Polyol IXOL B350 by oral gavage.
In the acute inhalation toxicity study (4 hour exposure to 5.47 ± 0.05 g/m3) no systemic effects were observed. However, systemic effects were observed in a subacute (28 days) inhalation study in which exposure to Polyol IXOL B350 at concentrations of 1 g/m3 or above induced changes indicative of systemic toxicity (viz. changes in haematology, clinical chemistry and organ weights).
In the absence of substance specific quantitative data on absorption, a default (worst case) absorption value of 100% is assumed for the oral and inhalation route.
Dermal absorption
As the test substance has a theoretical molecular weight of < 500, a log Kow of -0.03-3.3 and a water solubility of 4.4 g/L, a default dermal absorption figure of 100% should be selected. Nevertheless, Polyol IXOL B350 is a viscous substance (48560 ± 2460 mPa.s at20°C) which might limit dermal absorption. However, it is difficult to quantify the reduction of the dermal absorption figure based on the viscosity. Therefore, a default (worst case) absorption value of 100% is assumed for the dermal route
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