Registration Dossier

Administrative data

Description of key information

LD50 > 2000 mg/kg upon oral exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Weight of evidence evaluation based on both experimental and literature data..

Target substance was tested in a Balb/c 3T3 NRU assay for in vitro cytotoxicity. An IC50 of 9855 µg/ml was obtained as mean of 2 experiments. From the IC50 value, a LD50 of 3233.26 mg/kg was estimated.

Literature data on similar substances was all indicative of a low acute toxic potential.

Justification for classification or non-classification

The CLP Regulation (EC 1272/2008), Annex I, Part 3, Table 3.1.1 gives the following criteria for acute oral toxicity: "Category 4: 300 < ATE ≤ 2 000," where ATE is acute toxicity estimates in mg/kg bodyweight.

Based on available data, an LD50 > 2000 mg/kg bw was assumed, i.e. above the threshold for classification under the CLP Regulation (EC 1272/2008).