Registration Dossier

Administrative data

Description of key information

A study conducted with a TDI polyurea grease thickener is read across to members of the polyurea MDI category.

The oral administration of a TDI polyurea grease thickener base grease to rats by gavage, at dose levels of 375, 750 and 1500 mg/kg bw/day did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1500 mg/kg bw/day. The study is deemed suitable for read-across as both source and target substances contain structures with linear alkyl chains in the range of C8 to C18. As source and target substances are structurally similar, they are expected to demonstrate similar toxicity (or lack of toxicity) in toxicology studies. This is demonstrated by the similarity of available experimental data for mammalian toxicity endpoints.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Guideline study conducted to GLP suitable for read-across to support the data generated on other MDI-category substances

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Four studies were conducted with MDI category members and from all studies it was concluded that the test items should not be classified. Additionally an OECD 422 study conducted on a TDI category substance, deemed suitable for read-across, also concluded that classification is not required.