Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Route: .live2