Are local irritation and systemic toxicity evaluated as different endpoints?
Last reviewed: .
Are local irritation and systemic toxicity evaluated as different endpoints?
Yes: they are separate studies; Product Safety Labs, Study 65321 (OPPTS 870.1100, acute oral) and Study 65322 (OPPTS 870.1200, acute dermal) are the acute toxicity studies, and Study 65323 (OPPTS 870.2500) is the primary skin irritation study.
The Validation page states that NanoFlashing™ is tested under Good Laboratory Practice to US EPA Health Effects Test Guidelines, and it names Product Safety Labs, Study 65321, Study 65322, Study 65323 and Study 65324. Each was completed in 2024 and each was run on a sponsor-supplied sample. Each of the four covers one endpoint. Product Safety Labs, Study 65323, completed 16 February 2024, reported that the material it tested “is classified as non-irritating to the skin”, and Study 65324, completed 31 January 2024, reported that the material it tested “is not considered to be a contact sensitizer”; each result describes that sample under that study’s conditions.
Each of those studies describes one endpoint, on that sample, under those conditions. None of them establishes an agency approval, a general safety conclusion, an inhalation result or a health outcome, and irritation and sensitisation are separate endpoints answered by separate studies. A copy may be made available on our review of the request. Confidentiality obligations may apply to a given report.
Source: C-POLAR — Validation, https://cpolar.tech/validation/; Product Safety Labs, Study 65321, Study 65322, Study 65323 and Study 65324, 2024, US EPA Health Effects Test Guidelines; C-POLAR — Terms of Use, section 3, https://cpolar.tech/terms/.
Reviewed on .
Sources
- C-POLAR — Validation
- Product Safety Labs, Study 65321, Study 65322, Study 65323 and Study 65324, 2024, US EPA Health Effects Test Guidelines
- C-POLAR — Terms of Use