Registration Dossier

Ecotoxicological information

Toxicity to birds

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Short-term toxicity

In an avian acute oral toxicity single dose test (BASF SE, 15W0676/09W018, 2013) on Zebra finch (Taeniopygia guttata) with the test substance conducted according to EPA OPPTS 850.2100 (Avian Acute Oral Toxicity Test (2012)). The LD50 of the test substance was 366 mg/kg body weight.

Chronic toxicity

In a study on the reproductive toxicity of the test substance (Wildlife International, Ltd., 147-261, 2014) according to OECD 206 (1984) the NOEC of the test substance in the Northern Bobwhite after 5 months was determined to be 80 ppm, equivalent to 6.7 mg/kg body weight/day.

Key value for chemical safety assessment

Additional information

Short-term toxicity

An avian acute oral toxicity single dose key test (BASF SE, 15W0676/09W018, 2013) with the test substance was conducted according to EPA OPPTS 850.2100 (Avian Acute Oral Toxicity Test (2012)).The objective of the study was to evaluate the acute toxicity of the substance in zebra finches (Taeniopygia guttata) and to determine the oral LD50 and the no observed effect level (NOEL). The test substance was administered via a single oral dose of 64, 112, 196, 343 or 600 mg/kg body weight to groups of 5-months old zebra finches. Ten birds (5 males and 5 females) were used in each test substance group. The doses were administered in0.5% Carboxymethylcellulose in drinking water. Birds that have been fasted for about 2½ to 4½ hours were administered the test substance. Birds of all groups received food and water ad libitum throughout the test. The test was terminated after 14 days. All groups were observed for mortality, signs of clinical toxicity, impact on food consumption and body weight for 14 consecutive days post dosing. During the first week after dosing the food consumption in the dose groups ≥ 196 mg/kg body weight was decreased. The decrease was dose dependent. The body weight was not statistically significantly reduced in any of the dose groups and the body weight development was not impaired in comparison to the control group.). The LD50 of the test substance was 366 mg /kg b.w.

 

In addition in a supporting study (BASF SE, 11W0676/09W015, 2012) on the acute oral toxicity of the test substance to young adult bobwhite quail (Colinus virginianus) according to EPA-540/9-82-024 (1982) , the acute oral median lethal toxicity (LD50) of the test substance was 802 mg/kg body weight (confidence interval: 536 – 1266 mg/kg body weight). The highest dose tested causing no mortality was 250 mg/ kg body weight. The "No Observed Effect Level" (NOEL) was 125 mg/kg body weight. The analytically detected concentrations of the preparations given to the birds by gavage were within a range of ± 10% of the nominal concentrations. The following acute oral LD50 value of the test substance was LD50= 802 mg/kg body weight and the NOEL was 125 mg/kg bw.

 

Moreover in a supporting study (BASF SE, 13W0676/09W017, 2011) on the acute oral toxicity of the test substance to Anas platyrhynchos was conducted according to EPA OPPTS 850.2100 (Avian Acute Oral Toxicity Test (2012)), the acute oral median lethal toxicity (LD50) of the test substance was > 2000 mg/kg body weight. The highest dose tested causing no mortality was 2000 mg/kg body weight. The analytically detected concentrations of the preparations given to the birds by gavage were within a range of ± 10 % of the nominal concentrations.

 

Furthermore in a supporting study (BASF SE, 31W0676/09W011, 2011) on the avian dietary toxicity to Colinus virginianus was conducted according to EPA OPPTS 850.2200 (Avian Dietary Toxicity Test (2011)) the LC50 for chicks of the Bobwhite quail (Colinus virginianus) was 527 mg/kg diet. This corresponds to a daily dose of 70 mg/kg bodyweight/day. No toxic signs were observed. The food consumption was not affected. The body weights in the concentration groups were not statistically significantly different from those of the control group. The No Observed Effect Concentration (NOEC) was 170 mg/kg diet. This corresponds to a daily dose of 24 mg/kg bodyweight/day.

 

Additionally a supporting study (BASF SE, 32W0676/09W012, 2012) on the avian dietary toxicity to Anas platyrhynchos was conducted according to EPA OPPTS 850.2200 (Avian Dietary Toxicity Test (2011)). Under the conditions of this study the LC50 for ducklings of the Mallard duck (Anas platyrhynchos) was > 5000 mg/kg diet. This corresponds to a daily dose of > 282 mg/kg bodyweight/day. No compound-related mortality occurred. No toxic signs were observed.

 

Long-term toxicity

In a key study on the reproductive toxicity of the test substance (Wildlife International, Ltd., 147-261, 2014) according to OECD 206 (1984), 4 groups of 18 male/female pairs of Northern Bobwhite quail (Colinus virginianus) were fed with the test substance in the diet for a period of 21 weeks. Effects of nominal test concentrations of 80, 200 and 500 ppm, respectively, over 1 generation were compared to a control group. The tested concentrations were equivalent to estimated daily dietary doses of 5.3, 13.0 and 33.2 mg/kg/day (weeks 1-11), 7.8, 18.8 and 46.2 mg/kg/day (weeks 12-21), 6.7, 16.2 and 40.3 mg/kg/day (weeks 1-21), respectively. Dose related effects were not observed in adults. There were reductions in egg production at the 200 and 500 ppm test concentrations and a delay in the onset of egg production. In addition, at the 200 ppm test concentration there were statistically significant reductions in the number of hatchlings and 14-day old survivors as percentages of the maximum eggs set. At the 500 ppm test concentration there were statistically significant reductions in the number of hatchlings as percentages of live 3-week embryos and of the maximum eggs set, as well as reductions in 14-day old survivors as percentages of hatchlings, and of eggs set, and maximum eggs set. Therefore, the NOEC of the test substance in the Northern Bobwhite was determined to be 80 ppm, equivalent to 6.7 mg/kg body weight/day.

 

In addition in a supporting study (Wildlife International, Ltd., 147-277, 2015) on the reproductive toxicity of the test substance according to OECD 206 (1984), 4 groups of 18 male/female pairs of Mallard ducks (Anas playthrhynchos) were fed with the test substance in the diet for a period of five months.The no-observed-effect concentration for mallard exposed to the test substance in the diet during the study was therefore considered to be 80 ppm (10.1 mg/kg/day).