Registration Dossier
Registration Dossier
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EC number: 812-490-0 | CAS number: 1312943-21-7
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
There is no evidence from the experimental studies to indicate that MDI category members are absorbed systemically. No information on distribution, metabolism or excretion can be derived from the experimental data.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Experimental data for the mammalian toxicity Annex VII and VIII endpoints have been generated on substances within the MDI category.
The following conclusions can be drawn on the basis of a review of available key experimental data from physico-chemical and toxicological studies on the substances performed according to international technical guidelines and in compliance with GLP:
- MDI category substances do not appear to be absorbed via the gastrointestinal tract. This is supported by the lack of systemic toxicity at single doses of up to 2000 mg/kg bw, as suspension via oral gavage in the acute oral toxicity studies with Wistar rats and the repeat oral toxicity studies with Wistar rats at concentrations up to 1000 mg/kg/bw. Alternatively, the lack of toxicity via the oral route may also be indicative of high-threshold toxicity for the substance over the relatively short-term exposures examined
cannot be ruled out.
- MDI substances do not appear to be absorbed via the skin. This is supported by the lack of any systemic effects following occluded, or semi-occluded, application of 0.5 g to rabbit skinin vivostudies. Similarly, there was no dose dependent increases in stimulation index following topical application of MDI substance in a local lymph node assay. Additionally, in modified Buehler tests and guinea-pig maximisation tests no classifiable response was observed. There is also a lack of systematic toxicity in acute dermal toxicity studies conducted on four MDI category members. Although lack of dermal absorption is the likely scenario for the absence of systemic effects via this route of exposure, the alternative explanation of high threshold toxicity over the short-term exposure examined cannot be ruled out.
No available data from these studies allows conclusions to be drawn regarding distribution, metabolism or excretion of the polyurea MDI substances in the marketed grease base.
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