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Administrative data

Description of key information

analogue substance 1, EU B1, oral, LD50 > 2000 mg/kg

analogue substance 2, OECD 401, oral LD50 > 2200 mg/kg

other reported studies are with realibilaity 4 and are not used for classification nor for derivation of LD50 parameters

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Lack of exposure concentrations, only indication of mortality and necropsy findings after exposure time.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
no details on study desgin and doses. Only qualitative considerations

Additional information

Acute toxicity was assessed mainly through oral route on the target and analogue substance 2. Other exposure patterns ( dermal, inhalation and intraperitoneal) are used only for qualititative considerations.

Acute toxicity: oral

Two studies were considered in order to complete the assessment on Acute oral toxicity: One test was conducted on the substance itself but limited information is available regarding the method and the experimental results. Therefore, another test conducted on the Similar Substance 02 was considered in order to confirm the results of the first test.

The two results are consistent (LD50 > 10000 mg/kg bw and LD50 > 2200 mg/kg bw) and the substance is expected to have an LD50 > 2000 mg/kg bw.

Acute toxicity: inhalation

No deaths occurred at the highest exposure time of 8 hours, however, no indication regarding the exposure concentration was present. For this reason, the performed study is not suitable for classification purpose.

Acute toxicity: dermal

Rats were exposed to a single dermal application of the test substance. After 14 days of observation, no deaths occurred and no abnormalities were noted at necropsy.

Other sudies are available on another route of exposure (intraperitoneal) and were reported in the endpoint nevertheless, no indication on classification can be derived.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:

For Acute toxicity oral route:

Category 1: ATE <= 50 mg/kg bw

Category 2: 50 < ATE <= 200 mg/kg bw

Category 3: 200 < ATE <= 1000 mg/kg bw

Category 4: 1000 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be > 2000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.