Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.

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. 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 in all treatment groups. There were effects on embryofetal development in animals tested in the two highest dose groups of 100 mg/kg/day and 250 mg/kg/day. There were incidents of diaphragmatic hernia recorded in three fetuses from three litters of animals dosed at 250 mg/kg bw/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 indicate 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.