Registration Dossier

Administrative data

Description of key information

LD50 p.o. rat: > 2000 mg/kg bw (BASF SE, 2013)
LD50 dermal: > 2000 mg/kg bw (BASF SE, 2013)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw (BASF SE, 2013) of the undiluted test item Pentaerythritol, olig. react. prod. with 1- chloro-2,3-epoxypropane, react. prod. with acrylic acid were administered to two test groups of three fasted Wistar rats by gavage. No mortality occured. The LD50 was > 2000 mg/kg bw.

Acute dermal toxicity:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw (BASF SE, 2013) of the undiluted test item Pentaerythritol, olig. react. prod. with 1-chloro-2,3-epoxypropane, react. prod. with acrylic acid to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality occurred. The LD50 was > 2000 mg/kg bw.

In accordance with column 2 of REACH Annex VIII, no acute inhalation toxicity study was conducted as two other routes are provided.

Justification for classification or non-classification

EU classification according to Annex VI of the Directive 67/548/EEC: no classification required

GHS classification (GHS UN rev.3, 2009): no calssification required