Potassium 3-sulphopropyl methacrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
According to the later amendment of REACH, i.e. Commission Regulation (EU) 2016/863 of 31 May 2016, testing by the dermal route does not need to be conducted if:
— the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and
— no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies).
The oral LD50 in rats is >5000 mg/kg, no animal died at 5000 mg/kg, clinical signs were sedation, dyspnea, diarrhea, and all rats had recovered within 3 hours to 3 days after test articIe treatment. No clinical signs were noted at both skin irritation (registered substance SPM) and sensitization (read-across substance SPA) testing. Hence, testing can be waived.