Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
other: An assessment of TK properties is made based on the available information as per Annex VIII of REACH
Adequacy of study:
other information

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

ABSORPTION

Oral / GI tract

The substance has a molecular weight of 450 and is insoluble in water, therefore significant absorption is unlikely. However, it is noted that in an OECD 422 study signs of systemic toxicity were observed meaning that absorption must occur.

Inhalation

The low vapour pressure value (0.11 Pa at 20°C) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.

Dermal

The substance is a liquid, however update via the dermal route is likely to be hindered by the relatively large molecular weight (450) and the presence of the methacrylate group. Further, since the substance is practically insoluble in water dermal uptake is likely to be low.

The substance is not considered to be an irritant or to be corrosive to the skin and no systemic toxicity was observed in those studies. On the basis of read-across to an analogous substance skin sensitisation is not expected.

DISTRIBUTION

Since the molecular weight is reasonable high and the substance is insoluble it is unlikely that the substance is widely distributed throughout the body. However, clear effects on the liver in repeated dose studies suggests that the substance in some form will reach the liver via systemic distribution.

 

METABOLISM

The results of the genotoxicity assays have shown that genotoxicity is neither enhanced or diminished in the presence of the S9 metabolising system. 

 

EXCRETION

There is no evidence to indicate the route of excretion but insoluble substances are not favourable for urinary excretion in addition excretion via bile is also unlikely. Any test item that is not absorbed will be excreted in the faeces.