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Ecotoxicological information

Toxicity to birds

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Administrative data

Link to relevant study record(s)

Description of key information

Acute Toxicity
EPA OPPTS 850.2200, EPA OPP 71-2, OECD 205, NOEC 5620 ppm, LC50 >5620 ppm (all concentrations are representative of the active ingredient and corrected for sample purity), Gallagher et al. 2000a.
EPA OPPTS 850.2200, EPA OPP 71-2, OECD 205, NOEC 5620 ppm, LC50 > 5620 ppm (all concentrations are representative of the active ingredient and corrected for sample purity), Gallagher et al. 2000b.
EPA OPPTS 850.2100, EPA OPP 71-1, NOEL 1325 mg/kg, LD50 > 2250 mg/kg (all concentrations are representative of the active ingredient and corrected for sample purity), Gallagher et al 2000.
EPA OPPTS 850.2100, EPA OPP 71-1, NOEL 2250 mg/kg, LD50 > 2250 mg/kg (all concentrations are representative of the active ingredient and corrected for sample purity), Gallagher et al 1999.
NOEL 2000 mg/kg, LD50 > 2000 mg/kg, Acute oral toxicity limit test, Johnson 1996.
Repeated dose toxicity
Reproductive and Systemic Toxicity NOEC 200 ppm (200 mg/kg diet) (all concentrations are representative of the active ingredient and corrected for sample purity), EPA OPP 71-4, OECD 206, Mitchell et al 2000a.
Reproductive and Systemic Toxicity NOEC 200 ppm (200 mg/kg diet) (all concentrations are representative of the active ingredient and corrected for sample purity), EPA OPP 71-4, OECD 206, Mitchell et al 2000b.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for birds:
200 mg/kg food

Additional information

Toxicity caused by exposure to the test substance in birds has been addressed on a weight of evidence basis, where seven studies have been provided to address both acute and repeated dose toxicity (in the form of reproductive toxicity studies).

Two studies by Gallagher et al (2000a and 2000b) have been provided to address short term toxicity in both the Anas platyrhynchos (Mallard) and Colinus virginianus (Northern Bobwhite). In both studies birds were exposed to the test substance mixed into basal diet at the following nominal concentrations; 0, 562, 1000, 1780, 3160 and 5620 ppm. Concentration, homogeneity and stability was verified by HLPC. Under the conditions of the test, no mortality was observed up to the highest concentrations tested. The 5 day LC₅₀ is therefore > than 5620 ppm. and the NOEC can be said to be 5620 ppm. Dosing volumes converted from ppm to mg/kg diet according to the ratio of 1:1, hence 5620 ppm is equivalent to 5620 mg/kg diet.

Gallagher et al (2000) exposed Anas platyrhynchos to nominal test concentrations of 292, 486, 810, 1350 and 2250 mg /kg bw, in a single exposure via oral gavage. Birds were observed over 14 days for signs of toxicity or mortality. Under the conditions of the test no signs of toxicity were observed in comparison to the control. Thus it can be said that the LD₅₀> 2250 mg/kg. One female dosed at 2250 mg/kg bw showed signed of regurgitation, based on this the NOEL was determined to be 1350 mg/kg bw. Gallagher et al (1999) exposed Colinus virginianus to the test substance under the same conditions. No treatment related effects were observed in any of the test birds and thus the LD₅₀and the NOEL were determined to be > 2250 and 2250 mg/kg, respectively.

Johnson (1996), a 14 day acute toxicity study exposed Colinus virginianus via oral gavage in a limit test at 2000 mg/kg bw. Under the conditions of the study, no mortality or signs of toxicity were observed. It can be concluded that the test substance was non toxic to test organisms ≤ 2000 mg/kg bw. As no mortality was seen the LD₅₀ can be said to be > 2000 mg/kg bw and the NOEL 2000 mg/kg bw.

Two studies by Mitchell et al (2000 a and 2000b) provide long term reproductive toxicity data in both theAnas platyrhynchos(Mallard) and Colinus virginianus (Northern Bobwhite). Adult Anas platyrhynchos were exposed to the test substance over a period of 21 weeks, whereas Colinus virginianus were exposed for 22 weeks. Detailed examinations were made in both studies on the adults, offspring and reproductive parameters in order to assess the potential toxic effects of the test substance. Birds were exposed to the test substance in their diet at nominal concentrations of 50, 100 and 200 ppm. An untreated control was run concurrently for comparison. HPLC analysis was used to verify the homogeneity, stability and concentration of the dosed feed. The results were the same for both species; under the conditions of the test no statistically significant treatment related effects were observed in adults, offspring or reproductive parameters. The NOEC was determined to be 200 ppm a.i. Dosing volumes converted from ppm to mg/kg diet according to the ratio of 1:1, hence 200 ppm is equivalent to 200 mg/kg diet. The results obtained from this study, being the most sensitive, have been selected to represent the effects of the test substance based on the worst case scenario for repeated dose toxicity.

Six studies were performed according to GLP, in line with standardised guidelines, with a high standard of reporting and have thus been assigned a reliability score of 1 in line with the principles for assessing data quality set out by Klimisch (1997). The seventh study Johnson (1996) was performed to sound scientific principles with a good standard of reporting; however no standard guidelines were followed. The study was therefore assigned a reliability score of 2 according to Klimisch (1997). With the exception of Johnson (1996) all concentrations are representative of the active ingredient and were corrected for sample purity.

 

The available data are considered to be complete and the following conclusions for short term toxicity have been taken forward for risk assessment: Acute toxicity NOEL 1325 mg/kg, LD₅₀> 2250 mg/kg; Repeated dose NOEC 200 mg/kg diet.