Registration Dossier

Administrative data

Description of key information

LD50, oral, m/f > 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 dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The analogue substance was tested for acute oral toxicity in-vivo studies following OECD 401 (NONS dossier, 1988).

For the acute oral toxicity five males and five females of Wistar were dosed and the LD50, m/f > 2000 mg/kg bw.

Based on the read across considerations same results apply to Reactive Orange 12:2.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < 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 does not classified the substance.