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EC number: 943-670-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LD50 (oral) > 10.000 mg/kg bw
LD50 (oral), similar substance 1 = ca. 7000 mg/kg bw, equivalent to 2772 mg/kg bw of active ingredient.
Key value for chemical safety assessment
Additional information
The potential of the substance for acute toxicity following oral administration was tested in male and female rats of the RAIf (SPF) strain. 5 animals per sex per dose were used in tests conducted in 1976. The observation period was 14 days.
Signs and symptoms seen in rats included sedation, dyspnoea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 9 days. They were submitted to a necropsy at the end of the observation period. The LD50 of the test substance was determined to be > 10000 mg/kg bw.
As no detailed composition on the tested substance is available, the test is considered as a weight of evidence, supported by another test available on similar substance 1.
In this test, the potential of the substance for acute toxicity following oral administration was tested in male and female rats of the RAIf (SPF) strain. 5 animals per sex per dose were tested at doses of 3170, 4640, 6000 and 7750 mg/kg bw and observed for 14 days.
Within 2 hours of treatment, the rats in the dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur. Surviving animals recovered within 8 to 11 days. They were subjected to a necropsy whenever they died. Survivors were subjected to necropsy at the end of the observation period. In the 6000 mg/kg bw group, 1 female mortality occurred after 7 d, and in the 7750 mg/kg bw group, 3 male mortalities and 1 female mortality occurred after 24 h. The LD50 of the test substance was determined to be approximately 7000 mg/kg bw, equivalent to 2772 mg active ingredient/kg bw.
Therefore it can concluded that disperse Blue 73 is not classified as acutely toxic by oral exposure route.
Justification for classification or non-classification
The CLP Regulation (EC 1272/2008), Annex I, Part 3, Table 3.1.1 gives the following criteria for acute oral toxicity: "Category 4: 300 < ATE ≤ 2 000," where ATE is acute toxicity estimates in mg/kg bodyweight.
LD50 of the test substance is considered > 10.000 mg/kg bw and LD50 of similar substance 1 was determined to be ca. 2772 mg/kg bw in the chosen reference test, which is outside the above criteria.
Therefore, the test substance is not acutely toxic by the oral exposure route.
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