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Ecotoxicological information

Toxicity to birds

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Administrative data

Link to relevant study record(s)

short-term toxicity to birds: acute oral toxicity test (LD50-slope)
Data waiving:
other justification
Justification for data waiving:

Description of key information

The acute toxicity was tested on Bobwhite Quail with EDTA-FeNa. The LD50 was above 5000 mg/kg b.w. , the LC50 (5d dietary administration) was above 5000 mg/kg food, corresponding to > 5881 mg/kg bw and 5881 mg/kg food ZnK2EDTA respectively.

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:
5 881 mg/kg food

Additional information

The toxicity to birds was evaluated in two studies with EDTA-FeNa:

1. The acute toxicity of EDTA-FeNa was studied on Bobwhite quail according to the Guideline OPPTS 850.2100 and SETAC Europe (Leuschner 2008). The test item was administered at a single dose (1000, 2000, 3000 and 5000 mg/kg b.w.) to 5 males and 5 females in each tested dose and control. Animals were observed individually for effects on regurgitation, signs of intoxication and remission, abnormal behaviour, mortality, time of death, body weight and food consumption during 14 days. All surviving birds after the 14 days were sacrified, dissected and inspected macroscopically. The LD50was determined to be > 5000 mg/kg b.w., equivalent to > 5881 mg/kg b.w. EDTA-ZnK2 (431.8/367.1, MW ratio)

2. The acute toxicity after oral administration via the diet of five consecutive days to birds was studied in Bobwhite quail. Birds were fed a diet containing EDTA-FeNa at a concentration of 5000 ppm. Beginning of on day 6, the birds were fed the basal diet, free of the test item, for 8 additional days. At the end of the study all surviving birds were sacrificed, dissected and inspected macroscopically. Two controls were used. 10 birds were use per dose and per control (total 30 birds). After dosing all animals were observed for signs of intoxication and other abnormal behaviour, mortality, body weight and food consumption. At the end of the experiment all animals were sacrificed, dissected and inspected macroscopically.

No toxic signs were noted after oral administration of EDTA-FeNa via the diet at a concentration of 5000 ppm EDTA-FeNa (limit test). No test item-related inhibition of body weight gain was observed. No test item-related changes were noted at necropsy.

The LC50was > 5000 ppm (equivalent to > 5881 ppm EDTA-ZnK2 (431.8/367.1, MW ratio), and this corresponds to a LD50> 886.1 mg EDTA-FeNa/kg b.w./d corresponding to > 1042 mg EDTA-ZnK2/kg bw/d.

Based on the availability of these two short-term studies, on the fact that the mammalian dataset does not indicate acute or chronic toxicity of the test substance and for reasons of animal welfare, testing for long-term reproductive toxicity to birds is waived.