Registration Dossier

Administrative data

Description of key information

Acute administration by oral route LD50 > 5000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 993 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

No studies on "acute toxicity" are available for the substance in itself, nevertheless studies conducted with an analogue molecule (Similar Substance 01) were considere in order to complete the assessment. Further information are reported in the Read Across justification attached to section 13.

For the acute administration by oral route, the assessment of the substance is based on three studies.

The first study (Huntsman, 1977) was conducted according to a method similar to OECD 401. Ten rats per dose were administered with the following concentrations: 3170, 4640, 6000, 7750 and 10000 mg/kg body weight. The LD50 was 7993 mg/kg body weight.

The second study (Huntsman, 1984) was performed according to OECD 401 and a complete report is available. Ten rats were administered by gavage at a concentration of 5000 mg/kg body weight. At this concentration no mortality was observed.

The third study (Huntsman, 1973) was conducted following a method similar to OECD 401. Ten rats were administered at a concentration of 5000 mg/kg body weight. At the end of the observation period, no mortalities were observed.

Considering the results of all the studies the LD50 for the substance is considered to be > 5000 mg/kg body weight.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the 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 greater than 5000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity