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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

No toxicokinetic studies were performed with the test item. Physico-chemical and structural information suggest that the bioavailability of the substance is unlikely and the likelihood for bioaccumulation is low. This has been supported by repeat-dose toxicity studies with treatment durations of up to 90 consecutive days, which did not show any adverse effects up to the limit dose of 1000 mg/kg/day.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Assessment of the toxicokinetic behavior of test substance:

 

There were no studies available in which the toxicokinetic properties of the test substance were investigated. The test substance (molecular weight of 441.6 g/mol) is an off white solid powder (Ciba, 1996) with a log Pow > 8 (EPI Suite, 2012) and a water solubility of < 69 µg/L (Ciba, 1997). The vapor pressure was determined at 2.6E-7 Pa at 20°C (Ciba, 1997).

 

Absorption

Generally the smaller the molecule, the more easily it may be taken up. Molecular weights below 500 g/mol are favorable for absorption; molecular weights above 1000 g/mol do not favor absorption (ECHA GD 7c, 2008). Based on molecular weight the test substance could be absorbed in the gastrointestinal tract. However, the water solubility of the test article is very low, thus not favoring the substance to be readily dissolved in gastrointestinal fluids. Furthermore, passive diffusion is also not very likely to happen because of the high log P (> 4) of the test substance. To summarize, based on the physico-chemical parameters, the potential for absorption through the gastrointestinal tract is considered to be low but cannot be entirely be ruled out. In support of low GI absorption are the availably toxicity data obtained after oral exposure. In an acute toxicity study in rats no mortality and no systemic findings were observed after oral administration of test substance (RCC, 1996). In subchronic and subacute repeated dose toxicity studies (Covance, 1997 and Corning, 1997), no toxicological relevant effects were reported up to the highest dose tested (1000 mg/kg). No indications of systemic availability could be obtained in these studies, indicating low systemic availability and low likelihood for bioaccumulation.

 

For chemicals with a molecular weight < 100 dermal uptake is favored, while chemicals with a molecular weight > 500 have low potential to penetrate the skin (ECHA GD 7c, 2008). Highly lipophilic substances that come into contact with the skin can readily penetrate the lipid rich stratum corneum but are not well absorbed systemically. Although they may persist in the stratum corneum, they will eventually be cleared as the stratum corneum is sloughed off. In conclusion, a dermal uptake of the test substance is expected to be low. This is in line with the available toxicity data. In a guinea pig maximization test (RCC, 1997), none of the tested animals were sensitized after dermal exposure, therefore not giving any indication for dermal penetration. In a dermal acute toxicity study, no systemic findings were reported (RCC, 1996). In conclusion, dermal penetration is expected to be low.

 

No data from acute or repeated dose inhalation toxicity studies are available, which could provide information about the systemic distribution of the test substance after inhalation. Inhalative exposure to vapors is not of relevance as the substance has a very low vapor pressure.

 

Excretion

The excretion pathway is largely dependent on molecular size, polarity and water solubility. Therefore, the parent compound is expected to be excreted mainly via feces. Potential metabolites are either excreted via feces or urine, depending on their molecular size and water solubility after phase II metabolism.