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Administrative data

Description of key information

The oral LD50 value in rat is > 5000 mg/kg bw (OECD 401, GLP).
The dermal LD50 in rat is > 2000 mg/kg bw (OECD 402, GLP).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 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:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral route:

In an acute oral toxicity study according to OECD TG 401 and GLP, groups of fasted, young adult Wistar rats (5/sex) were given a single oral dose of the test substance in 1% methyl cellulose at 5000 mg/kg bw and consecutively observed for 14 days. No mortality occured and no signs of toxicity were observed during the 14 day observation period. Bodyweight development was not impaired.

The oral LD50 value was determined to be > 5000 mg/kg bw.

Inhalation route:

No experimental data is available.

Dermal route:

The acute dermal toxicity of the test substance at the limit dose of 2000 mg/kg bw, was studied in Wistar rats (5/sex) according to OECD TG 402 and GLP. There were no deaths and no systemic response to treatment in any animal throughout the study. No dermal reactions were observed in any animal during the study. Two male animals showed a temporary bodyweight decrease during the first week of observation. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study. Based on these results the acute lethal dermal dose to rats of the test substance was demonstrated to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008.