Registration Dossier

Administrative data

Description of key information

The key acute oral toxicity study gave an LD50 (oral) >2000 mg/kg bw (OECD 423, acute toxic class method) in rats (Wolf, 2005). There were no clinical signs or necropsy findings. 
The key acute dermal toxicity study gave an LD50 (dermal) >2000 mg/kg bw (OECD 402, limit test) in rats (Bernat, 2005). There were no clinical signs, signs of local irritation or necrospy findings.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute oral toxicity:

Three acute oral toxicity studies are available for Crude Tall Oil. In all cases, the observed LD50 was greater than 2000 mg/kg bw. The key study was selected as the most recent study which was conducted in accordance with OECD Test Guideline 423 and in compliance with GLP (Wolf, 2005).

Acute dermal toxicity:

Only one acute dermal toxicity study is available for Crude Tall Oil. The test was carried out in accordance with OECD Test Guideline 402 (limit test) and in compliance with GLP (Bernat, 2005). The observed LD50 was greater than 2000 mg/kg bw.

Justification for classification or non-classification

The available data for acute oral and dermal toxicity in the rat indicate that Crude Tall Oil is not classified for acute toxicity according to the criteria of EU Directive 67/548/EEC or Regulation 1272/2008.

There are no data available for the inhalation route.