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Administrative data

Description of key information

NOAEL (oral, 28 d) = 1000 mg/kg/day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In the CLP Regulation (EC 1272/2008), target organ toxicity - repeated exposure (STOT-RE) means specific, target organ toxicity arising from a repeated exposure to a substance or mixture. All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed are included.

Substances are classified in category 2 for target organ toxicity (repeat exposure) on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations.

If classification is based on the results obtained from studies conducted in experimental animals, the dose/concentration guidance values to classify refer to effects seen in a standard 90-day toxicity study conducted in rats (category 2):

-Oral (rat) 10 < C ≤ 100 mg/kg bw/day

-Dermal (rat or rabbit) 20 < C ≤ 200 mg/kg bw/day

-Inhalation (rat) gas 50 < C ≤ 250 ppmV/6 h/day

-Inhalation (rat) vapour 0.2 < C ≤ 1 mg/litre/6 h/day

-Inhalation (rat) dust/mist/fume 0.02 < C ≤ 0.2 mg/litre/6 h/day.

The assessment shall be done on a case-by- case basis; for a 28-day study the guidance values is increased by a factor of three.

The repeated dose toxicity (oral) of the substance was evaluated in a subacute 28-day toxicity study to rat, according to the OECD Guideline 407. Under the test conditions the substance there were no signs of a toxic reaction to treatment noted in animals and a NOEL of 1000 mg/kg/day was established. Therefore, according to the CLP Regulation (EC 1272/2008), the substance is not classified for target organ toxicity (repeated exposure).