Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Available data suggest that the registered substance as a whole may be absorbed to some extent following oral and inhalation routes of exposure. Some components within this complex mixture constituting the registered substance may be more absorbed more readily than other components.

Key value for chemical safety assessment

Absorption rate - oral (%):
50
Absorption rate - dermal (%):
50
Absorption rate - inhalation (%):
100

Additional information

No specific ADME and/or toxicokinetic data are available for the registered substance. Following a single oral administration to rats of both sexes at the limit dose of 2000 mg/kg no signs of systemic toxicity were noted although some effects on body weight (slightly reduced body weight gains in males, body weight loss in one out of the three treated females) were observed during the first week after treatment. Similarly, following a single dermal application of a structurally related substance at the limit dose of 2000 mg/kg no signs of systemic toxicity but only local irritating effects were noted. In inhalation experiments in which mice were exposed for 2 hours to very high aerosol concentrations, clinical signs such as reduced activity, uncoordinated movements together with dyspnoea were noted in animals before death, however, the LC50 was calculated to be 19 ± 1.4 mg/L, much higher than the limit dose.

In a developmental toxicity study (Oral Gavage) in the rat (OECD 414) there was a slight decrease in food consumption and body-weight gain. There were also minor effects on embryofoetal development. These effects were observed in animals tested at the highest dose level of 1000 mg/kg/day. There were no test-item-related findings upon necropsy.

These data suggest that the registered substance as a whole may be absorbed to some extent following oral and inhalation routes of exposure. Some components within this complex mixture constituting the registered substance may be more absorbed more readily than other components. Although acute dermal data gives little indication as to the absorption through the skin, there will be at least some, because the substance was able to penetrate to produce skin sensitisation (based on results of a LLNA study) and animal studies with materials called "shale oils" in the public domain evidenced a carcinogenic response following repeated dermal applications to mice and rabbits. Although the registered substance is irritating for both the skin and eye, these tumours were not considered related only to local effects.

In the absence of any fully quantitative information, in line with ECHA guidance inhalation absorption is considered to be 100 % and oral and dermal absorption are considered to by 50 % for each of these routes.