Registration Dossier

Administrative data

Description of key information

LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 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 study available

Additional information

The test substance was tested for its Acute Oral Toxicity according to a the OECD guideline 423, following oral administration of a single dose of 2000 mg/kg bw (limit test). No lethality occurred after application of 2000 mg/kg body weight. Besides unspecific symptoms the animals showed impairments of motility and respiration starting 30 – 60 minutes after application. Additionally urine was discolored reddish on day one. Later on up to day 3 urine was discolored dark as well as feces. From day 4 until the end of the study no symptoms were observed. One animal showed a slight body weight reduction in the second week of the study. Development of body weight was not impaired in the other animals. All animals were killed at the end of the observation period. They showed no macroscopically visible changes.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one offour toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be more than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).