Registration Dossier

Administrative data

Description of key information

Acute toxicity: oral (gavage): acute toxic class method (GLP, OECD 423): species rat (Wistar, male/female): LD50 > 5000 mg/kg bw (male/female)
Acute toxicity: dermal: standard acute method (GLP, OECD 402): semiocclusive: species rat (Wistar, male/female): LD50 > 2000 mg/kg bw (male/female)
As a consequence, no DNEL for acute toxicity has to be derived and no distinct chemical safety assessment, including exposure determination and risk characterisation, has to be performed in accordance with article 14(4) of the REACH regulation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via dermal route

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

Additional information

The test item did not show any signs of acute toxicity via both oral and dermal exposure. As a consequence, only the lower limits which have been applied according the OECD guidlines were derived. This conclusion is furter supported by the fact that also in a repeated dose toxicity studies no signs of toxicity were observed.

In accordance with colum 2 of REACH annex VIII, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size (REACH, Annex VIII, section 8.5.2, colum 2). Since the vapour pressure of the substance is extremely low, no inhalative exposure is to be expected.

Justification for classification or non-classification

Since neither any classification criteria according to GHS-CLP (Regulation (EC) No. 1272/2008) nor any criteria according to DSD (Directive 67/548/EEC) are fulfilled, the substance is not classified for acute toxicity, neither by the oral nor by the dermal route.