2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide

Toxicity to birds

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to birds: reproduction test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

In-life initiated/completed: 13-Apr-2012 to 19-Nov-2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 206 (Avian Reproduction Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.2300 (Avian Reproduction Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Dose method:

homogenously mixed into feed (accounts for technical substances)

Analytical monitoring:

yes

Vehicle:

yes

Remarks:

Corn oil

Details on preparation and analysis of diet:

Control diet and each of the treated diets were prepared approximately weekly and presented to the birds each week. Dietary concentrations were adjusted for purity of the test substance and are presented in mg ai/kg feed (ppm a.i.). The adult diet used for all phases of each study was Teklad Game Bird ration. The test substance was weighed, dissolved in acetone, and mixed with corn oil. The mixture was mechanically mixed into the adult feed for five minutes using a Kitchen Aid mixer as a pre-mix. The pre-mix was then mixed with the appropriate mass of raw feed in a Turbula mixer for five minutes.

Homogeneity of the test substance in the diet was evaluated by collecting samples from the 60 ppm and 240 ppm dietary levels. Samples were collected from the top, middle, and bottom of the mixing vessel following the initial feed mixing procedure. Room stability of the test substance in the diet was evaluated by collecting samples from the 60 ppm and 240 ppm dietary levels. Feeders for each of the treated diets were placed in the study room for a period of 7 days, samples were then taken from these feeders. Freezer stability of the test diet was also evaluated. The sampling procedures were performed to assess stability of the test substance under actual test conditions. To verify test concentrations, samples were taken on Week’s 1, 5, 10, 15 and 20 of the dosing phase of the study and were analyzed to measure the amount of Triflumuron technical in the diet. The diet samples were stored in a freezer prior to analysis.

Test organisms (species):

Colinus virginianus

Details on test organisms:

Farm raised quail (Colinus virginianus) which were healthy and obtained on 13 April 2012. All birds were from the same hatch and were approximately 14 weeks of age upon arrival. The birds were approaching their first breeding season and had not been previously used in testing. The test lot of birds were considered to be in good health and acclimated to the laboratory environment for approximately three weeks prior to experimental start.

Limit test:

no

Total exposure duration (if not single dose):

23 wk

Nominal and measured doses / concentrations:

The nominal amounts of Triflumuron technical in the dietary feed were administered at levels of 0 (control), 60, 120, and 240 ppm. The average measured amounts of Triflumuron technical for Week’s 1, 5, 10, 15, and 20 were determined as 0, 55, 107, and 220 ppm representing percent nominal values of 92%, 90%, and 92%, respectively. These values correspond to daily dietary dose levels of 0, 4.0, 7.9, and 16.1 mg a.s./kg body weight/day, respectively.

Details on examinations and observations:

The test birds were acclimated to the test facility and study cages for approximately three weeks prior to experimental start. During the acclimation, all birds were observed daily. Birds exhibiting abnormal behavior or debilitating physical injuries were not used for the test. During the study, all adult birds were observed daily for signs of toxicity or abnormal behavior. Additionally, all offspring were observed daily from hatching until 14 days of age. A record was maintained for all clinical observations and mortalities.

Details on reproductive parameters:

Reproductive parameters observed: eggs laid, eggs cracked, percent eggs not cracked of laid, eggs set and percent eggs set of eggs laid, eggshell strength and thickness were evaluated. The embryo endpoints included the number of viable embryos, the number of live embryos, the percent viable embryos of eggs set, and the percent live embryos of viable embryos.

Key result

Duration (if not single dose):

23 wk

Dose descriptor:

other: LOAEL

Effect level:

> 240 other: ppm

Conc. / dose based on:

act. ingr.

Basis for effect:

reproductive parameters

Remarks on result:

other: Equivalent to the measured concentration 220 ppm or the achieved dose of 16.1 mg a.s./kg bw/day.

Key result

Duration (if not single dose):

23 wk

Dose descriptor:

other: NOAEL

Effect level:

240 other: ppm

Conc. / dose based on:

act. ingr.

Basis for effect:

reproductive parameters

Remarks on result:

other: Equivalent to a measured concentration of 220 mg ai/kg feed or the mean achieved dose of 16.1 mg a.s./kg bw/day.

Further details on results:

No effects on adult birds were seen at any concentration of the test material. There were no effects on reproductive endpoints and no hatchling effects.

Validity criteria fulfilled:

yes

Conclusions:

The No Observed Adverse Effect Level (NOAEL) for both parental toxicity and reproduction endpoints of bobwhite quail exposed to Triflumuron technical was 240 ppm (nominal test level) with a measured concentration of 220 mg a.s./kg feed or the mean achieved dose of 16.1 mg a.s./kg bw/day. The Lowest Observed Adverse Effect Level (LOAEL) was >240 ppm (nominal test level) equivalent to the measured concentration 220 ppm or the achieved dose of 16.1 mg a.s./kg bw/day.

Executive summary:

Adult bobwhite quail (Colinus virginianus) were exposed to Triflumuron technical for approximately 23 weeks to nominal dietary levels of control, 60, 120, 240 ppm (mg ai/kg feed). Bobwhite quail were approximately 18 weeks old at experimental start with 18 pairs of birds at each treatment level. Birds were observed for mortality, abnormal behavior and signs of toxicity; adult body weight and feed consumption were measured; gross pathology was conducted; reproductive parameters, as well as hatchling health, growth and survival, were examined. No adverse effectes on parent animals or offspring were observed. The NOAEL for all parameters was determined to be 240 ppm and the LOAEL was determined to be >240 ppm.

Description of key information

Adult bobwhite quail (Colinus virginianus) were exposed to Triflumuron technical for approximately 23 weeks to nominal dietary levels of control, 60, 120, 240 ppm (mg a.s./kg feed). Bobwhite quail were approximately 18 weeks old at experimental start with 18 pairs of birds at each treatment level. Birds were observed for mortality, abnormal behavior and signs of toxicity; adult body weight and feed consumption were measured; gross pathology was conducted; reproductive parameters, as well as hatchling health, growth and survival, were examined. No adverse effects on parent animals or offspring were observed. 

The No Observed Adverse Effect Level (NOAEL) for both parental toxicity and reproduction endpoints of bobwhite quail exposed to Triflumuron technical was 240 ppm (nominal test level) with a measured concentration of 220 mg a.s./kg feed or the mean achieved dose of 16.1 mg a.s./kg bw/day. The Lowest Observed Adverse Effect Level (LOAEL) was >240 ppm (nominal test level) equivalent to the measured concentration 220 ppm or the achieved dose of 16.1 mg a.s./kg bw/day.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for birds:

16.1 mg/kg bw/day