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EC number: 226-939-8 | CAS number: 5567-15-7
Oral LD50 values for Diarylide Yellow Pigment 83 are > 2000 mg/kg bw, the limit for classification (LD50(key study) > 15,000 mg/kg bw). No lethality was observed after acute inhalation exposure to the maximum technically feasible test concentration of 4.4 mg/L Pigment Yellow 13 (strucutral analogue) and 0.23 mg/L Pigment Yellow 17 (strucutral analogue).
No lethality was observed after single dermal application of 1710 mg/kg bw Pigment Yellow 13 (strucutral analogue).
Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the maximal applicable dose of 15000 mg/kg bw. No animal died during the 14 day observation period, resulting in a LD50 >15000 mg/kg bw.
Classification for acute oral toxicity is not necessary according to Regulation (EC) No 1272/2008.
Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.
Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .
Acute inhalation toxicity of the test item has been investigated in male and female Wistar rats. They were exposed to 230 mg test substance per cubic meter for 4 h (maximal applicable dose). All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 230 mg/m³ for the inhalation of dust.
Acute dermal toxicity of the test item was tested in male and female Sprague-Dawley rats. The maximal applicable dose (3 g test item /kg bw suspended in polyethylene glycol:water 50:50 - final volume 9.9 ml; corresponding to 1710 mg PY13/kg bw) were applied to the skin. No clinical signs were observed and no animals died during the 7 day observation period, resulting in a LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw).
Classification for acute dermal toxicity is not necessary according to Regulation (EC) No 1272/2008.
Reliable data from several guideline studies on acute toxicity after oral application are available for Pigment Yellow 83 and its structural analogues, Pigment Yellow 12, Pigment Yellow 13, Pigment Yellow 14, Pigment Yellow 17, Pigment Yellow 55, Pigment Yellow 126, Pigment Yellow 127, Pigment Yellow 170, Pigment Yellow 174 and Pigment Yellow 176 (please refer to read across justification document, IUCLID section 13). These data reveal a very low acute oral toxicity of the pigments of this category: LD50 values for all investigated test items in rats are above 2000 mg/kg bw, the upper limit for classification. Even in tests performed with much higher concentrations (up to 15000 mg/kg bw) no animals died during the post observation period.
Based on these data it is concluded that no classification for acute oral toxicity is necessary for Diarylide Pigment Yellow 83.
Acute toxicity after inhalation exposure was investigated with the strucutral analogues, Pigment Yellow 13 and Pigment Yellow 17. In the guideline study on acute toxicity after inhalation exposure performed with Pigment Yellow 17 rats were exposed to the maximum technically feasible dust concentration of 0.23 mg/L (MMAD about 1.1 μm). No lethal effects, no severe clinical symptoms indicating a life-threatening or moribund state, and no gross morphological abnormalities were observed. Similar results were obtained with Pigment Yellow 13 in two studies, which were equivalent to guideline studies. All rats exposed to aerosol concentrations of 4.2 mg/L or 4.4 mg/L for 4 h survived during the 14 - days observation period. As no lethal effects occurred at the maximum technically feasible concentrations it is concluded that the members of the Diarylide Yellow Pigments category have not to be classified for acute toxicity after inhalation exposure.
Acute toxicity after dermal application has been tested with Pigment Yellow 13 (strucutral analouge) in male and female rats which received 3000 mg/kg bw of the test item (corresponding to 1710 mg/kg bw pure Pigment Yellow 13). No lethality occurred during the 7 day observation period and no macroscopically visible changes were observed at necropsy. Taking into account that the members of this category a) show very low toxicity after oral application, b) do not induce skin irritation and c) are not expected to penetrate through the skin due to their very low water solubility and based on the data on acute toxicity after dermal application of Pigment Yellow 13 it is concluded that Diarylide Yellow Pigments have not to be classified for acute dermal toxicity.
No specific toxic effects were observed after acute oral, inhalative or dermal exposure indicative of a specific target organ toxicity. For additional information refer to read across justification, IUCLID Chapter 13.
Based on the reported study data Diarylide Yellow Pigment 83 has not to be classified for acute toxicity according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC.
Furthermore, Diarylide Yellow Pigments have not to be classified for specific target organ toxicity – single exposure according to Regulation (EC) No 1272/2008, as no specific toxic effects were observed after acute exposure.
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