Registration Dossier
Registration Dossier
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EC number: 290-924-2 | CAS number: 90294-40-9
Endpoint summary
Administrative data
Description of key information
LD50 >5000 mg/kg bw (based on test material)
LD50 >2850 mg/kg bw (based on active ingredient)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
A study is available for analogue substance 1 following OECD 401 (Huntsman, 1974).
Ten rats (5 male and 5 female) were administered 5000 mg/kg bw test substance by oral gavage and observed for 14 days. All animals survived until the end of the study period and no changes in the body weight and macroscopic findings were observed. The only clinical signs observed, were orange stained urine and faeces.
Based on the observations, median lethal oral dose (LD50) to rats of the substance was found to be greater than 5000 mg/kg bodyweight based on the test material and >2850 mg/kg bw based on the active ingredient.
Based on the read across considerations same results apply to Acid Orange 144.
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 2850 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.
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