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EC number: 939-379-0
CAS number: -
Gelbpigment E4GN was administered by gavage to 5 male and 5 female Wistar rats per dose group in daily doses of 0, 100, 300 or 1000 mg/kg body weight for 29 days. The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done.
Survival was not affected by the treatment with the test substance.
At clinical observations the only treatment-related finding was that the color of feces was changed (yellowish) in cages of treatment groups. It seems to be obvious that this finding is caused by the color of Gelbpigment E4GN.
At histopathology some yellowish material was seen in the lumen of the large intestine (cecum, colon, rectum) of almost all rats treated with 1000 mg/kg and, additionally, in the rat of the 300 mg/kg group, which died during blood sampling. However, in all cases no such material was detected intracellularly or related to any other lesion seen in the affected organs. Therefore, this is assessed to be a sign of exposure and not as adverse.
Body weight development of males and females was not retarded by the treatment up to 1000 mg/kg. Mean food and water intake in treated groups was not relevantly changed.
Neither hematology nor clinical chemistry gave evidence for toxicologically relevant treatment-related effects up to 1000 mg/kg.
Gelbpigment E4GN was administered orally by gavage to 5 male and 5 female Wistar (HsdRCCHan:Wist) rats per dose group using ethanol/ Kolliphor HS15/ tap water (10%/ 40%/ 50%; v/v/v) as vehicle, in daily doses of 0, 100, 300, 1000 mg/kg b.w. for a period of 4 weeks.
Under the conditions described the no observed-adverse-effect level (NOAEL) for repeated oral administration of Gelbpigment E4GN to male and female Wistar rats was >1000 mg/kg b.w.
The no-observed-adverse-effect-level (NOAEL) for Gelbpigment E4GN is > 1000 mg/kg based (1000 mg/kg bw was the highest applied dose). The only treatment findings were the colour of faces (yellowish changed) and yellowish material at histopathology in the lumen in the large intestine (cecum, colon, rectum) of almost all rats treated with 1000 mg/kg bw. It seems obvious that this findings are caused by the colour of Gelbpigment E4GN.
Survival was not affected by the treatment with the test substance and no functional or morphological changes were observed. Therefore a classification is not justified.
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