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Diss Factsheets

Administrative data

Description of key information

Oral: LD50 > 6700 mg/kg bw for rat; LD50 > 8900 mg/kg bw for mouse
Dermal: LD50 > 2000 mg/kg bw for rat (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
8 900 mg/kg bw
Quality of whole database:
Both studies have limitations (lack of details on experimental conditions) and were performed before GLP exist but they have concordant results in two different species (rats and mice).

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
Quality of whole database:
Study with Klimisch score 1 performed in compliance with GLP and OECD guideline 402.

Additional information

No mortality was observed in mice up to 10 mL/kg bw; this result was confirmed in rats where low mortality (1/5 animals) was observed at 7.5 mL/ kg bw. Also, the high dermal LD50 (>2000 mg/kg bw) confirms the low acute toxicity potential that has been demonstrated by oral exposure in mice and rats. Rodents species are generally used to assess this endpoint, therefore those results should be relevant to humans.


Justification for selection of acute toxicity – oral endpoint
Better quality and more details are reported in the report compared to the other study available.

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Oral and dermal LD50 are higher than 2000 mg/kg bw in mice and/or rats. Therefore the substance is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008.