Registration Dossier

Administrative data

Description of key information

Acute toxicity: oral: LD50> 2000 mg/kg bw (Key study, rel. 1)
Acute toxicity: dermal: LD50> 2000 mg/kg bw (Key study, rel. 1)
Acute inhalation: no data.

Key value for chemical safety assessment

Additional information

Acute toxicity: oral

A key study was identified (Tetsuo Chida, 1992, rel. 1). In this limit acute oral toxicity study performed similarly to the OECD test guideline No. 401 and in compliance with GLP applied to industrial chemicals in Japan (1984), rats were administered a single oral dose of 2000 mg P-#620/kg bw in 0.5% Tween 80 in 0.5% CMC-Na (1.0 mL/100 g) by gavage.No mortality occurred during the study. No abnormal clinical signs were found. No abnormality was revealed at autopsy.

Oral LD50 Combined > 2000 mg/kg bw

Acute toxicity dermal:

A key study was identified (Allan, 1992, rel. 1). In this limit acute dermal toxicity study performed according to the E.U method B.3 and in compliance with GLP, rats were occlusively exposed to undiluted P-#620 at dose of 2000 mg/kg bw. No mortality occurred during the study. There were no signs of systemic reaction to treatment. Sites of application showed no irritation or other dermal changes.No abnormality was revealed at autopsy

Dermal LD50Combined > 2000 mg/kg bw

Justification for classification or non-classification

Harmonized classification:

The test item has no harmonized classification for human health according to the Regulation (EC) No. 1272/2008 including the ATP2 draft.

Self classification:

Oral route:

Based on the available data, the test item is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is higher than 2000 mg/kg bw

- not classified according to the Directive 67/548/EEC as the LD50 is higher than 2000 mg/kg bw

Dermal route:

Based on the available data, the test item is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is higher than 2000 mg/kg bw

- not classified according to the Directive 67/548/EEC as the LD50 is higher than 2000 mg/kg bw