Neurotoxicity in Solvents
Rationale
Neurotoxicity is a form of inherent hazard. A primary objective of the CleanGredients® database is to provide guidance for choosing chemicals that are inherently less hazardous than conventional options. Products formulated with safer chemicals have lower risk associated with accidents or exposure across the product lifecycle.
Listing Requirements
As a prerequisite for being listed in CleanGredients, all solvents must have their neurotoxicity data evaluated by a third party.
Solvents listed in CleanGredients cannot require a GHS categorization of 1 or 2 and must have neurotoxicity test results of at least:
- Oral 90-day LOEL/LOAEL > 100 mg/kg-bw/day
- Dermal 90-day LOEL/LOAEL >200mg/kg-bw/day
- Inhalation (Gas) 90-day LOEL/LOAEL >250ppm/6hr/day (Vapor) 90-day LOEL/LOAEL >1.0mg/L/6hr/day (Dust/Mist/Fumes) 90-day LOEL/LOAEL >0.2mg/L/6hr/day
Though test data is preferred, analog data is acceptable. If there is insufficient data to characterize this endpoint, the solvent is still eligible to be listed on CleanGredients if it meets the remaining criteria.
Data and Submission Guidance
Recommended test methods for neurotoxicity include:
- OECD Test No. 424 - ‘Neurotoxicity Study in Rodents’
- OPPTS Harmonized Guideline 870.6200 – Neurotoxicity screening battery Other similar or significant evidence will also be considered. Please see the OECD SIDS Test Guidelines for more information.