Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)

Toxicity to birds

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to birds: acute oral toxicity test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25/04/2001 - 12/10/2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: US EPA FIFRA Guideline 71-1

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.2100 (Avian Acute Oral Toxicity Test)

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Dose method:

gavage

Analytical monitoring:

no

Vehicle:

no

Details on preparation and analysis of diet:

Test substance was dispersed in deionized water. The concentration of the test substance in the diluent was adjusted to provide a constant volume to body weight dosage for all treatment birds. A single dose of the test substance was orally intubated directly into the crop of each bird at the beginning of the experiment.

- Nominal concentration (mg/kg feed): 0, 28, 47, 78, 130, 216, 360 and 600 mg a.s./kg bodyweight.

Test organisms (species):

Colinus virginianus

Details on test organisms:

- Test organism: Northern bobwhite (Colinus virgianus)
- Source: Barrett’s Quail Farm, Houston.
- Age at test initiation: 16 weeks of age
- Weight at test initiation: 228 – 308 g
- Sexes used: Male and female (equal numbers in each group)
- Disease free: yes
- Diet: Wildlife international game bird feed (fasted for 18 hours prior to dosing

Limit test:

no

Total exposure duration (if not single dose):

21 d

Post exposure observation period:

Post-exposure observation period was 21 days.

No. of animals per sex per dose and/or stage:

10 animals (5 males and 5 females) per dose level
10 vehicle control animals (5 males and 5 females) per dose level

Control animals:

yes

Nominal and measured doses / concentrations:

Initial concentrations: 0, 28, 47, 78, 130, 216, 360 and 600 mg/kg bw

Details on test conditions:

- For vehicle control: 10 vehicle control animals (5 males and 5 females) per dose level
- For treated: 10 animals (5 males and 5 females) per dose level
- Housing: Birds housed indoors in batteries of pens
- Temperature: 23.34± 0.5°C
- Humidity: 44%± 12%
-Lighting: ca. 143 lux

Housing and husbandry practices were based on guidelines established by the National Research Council.

Details on examinations and observations:

MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: Observed twice daily

BODY WEIGHT
- Time schedule for examinations: Bodyweight was measured on Days 0, 3, 7 and 14 and 21 of the test.

FOOD CONSUMPTION
- Time schedule for examinations: Estimated feed consumption was measured on Days 0, 3, 7 and 14 and 21 of the test.

Necropsy
-With the exception of two mortalities, all test birds were subjected to gross necropsy.

Details on reproductive parameters:

No information provided.

Reference substance (positive control):

not specified

Key result

Duration (if not single dose):

21 d

Dose descriptor:

LD50

Effect level:

226 mg/kg bw

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 179- 285 mg a.s./kg bodyweight

Duration (if not single dose):

21 d

Dose descriptor:

NOEL

Effect level:

78 mg/kg bw

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Repellency factors (if applicable):

Not applicable.

Mortality and sub-lethal effects:

One female in the control group was noted with foot injury. This was however, considered not to be treatment related.

At the 28 mg/kg dose level, one male was noted ruffled in appearance on the morning of Day 6. The bird was noted as normal in appearance on the afternoon of Day 6. At the 47 mg/kg dose level, one male was noted with a ruffled appearance on Day 3. Lethargy ad/or ruffled appearance were noted intermittently on Day 8 in three birds dosed at 47 mg/kg and in seven birds on Day 7, dosed at 78 mg/kg. All birds have recovered within the next day.
Lethargy, ruffled appearance, wing droop, loss of co-ordination, rapid respiration and gaping were noted in birds dosed at 130 mg/kg.

At the 216 mg/kg dose level the following signs were observed: lethargy, ruffled appearance, wing droop, depression, reduced reaction to sound and movement, salivation, loss of co-ordination, lower limb weakness, rapid respiration, regurgitation and hunched posture.

At the 360 mg/kg dose level due to the emaciated body condition, six birds were euthanised. Clinical sign in other birds were similar to that observed at the 216 mg/kg dose level.

Signs noted in the 600 mg/kg test group were lethargy, ruffled appearance, reduced reaction to sound and movement, prostrate posture, gaping, salivation and watery faeces.

There was a dose responsive loss in bodyweight in all birds at all dosage levels.

There were no apparent treatment related effects on feed consumption at 28 mg/kg. There were treatment related effects on feed consumption at the 47 through 600 mg/kg dose levels.

There was 10 % mortality in the 130 mg/kg dose group. At 216 mg/kg, there was 40% mortality. At 360 mg/kg, 90% mortality was observed, with 100% mortality observed at 600 mg/kg

Effects on reproduction:

No information provided.

Results with reference substance (positive control):

No information provided.

Further details on results:

The acute oral LD50 for Northern bobwhite was found to be 226 mg/kg. Lesions observed at necropsy, primarily associated with necrosis in the esophagus and crop, would indicate a “point of entry” effect of the test substance.

Reported statistics and error estimates:

Statistics were performed using C.E. Stephan et al and Probit analysis, moving averages method or the binomial probability method.

Table 1. Mortality data

 

Mean measured concentration (mg a.s. /kg)	Percent Mortality
0	0
28	0
47	0
78	0
130	10
216	40
360	90
600	100

Validity criteria fulfilled:

yes

Conclusions:

Based on the results of this study, the LD50 for Northern bobwhite was found to be 226 mg/kg bodyweight and the no mortality level was 78 mg/kg bodyweight. Lesions observed at necropsy, primarily associated with necrosis in the esophagus and crop, would indicate a ''point of entry'' effect of the test substance.

Executive summary:

In a study conducted in accordance with US EPA FIFRA Guideline 71-1, Northern Bobwhite (Colinus virginianus) were exposed to the test material, N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate (Bardap 26), for 21 days, at concentrations of 0, 28, 47, 78, 130, 216, 360 and 600 mg/kg. A vehicle control of deionised water was also used. Male and female test animals were used, with 10 animals (5 males and 5 females) per test concentration and vehicle control.

Mortality and signs of clinical toxicity were observed twice daily and bodyweight and estimated feed consumption were measured on Days 0, 3, 7 and 14 and 21 of the test. Under the conditions of this study, the acute oral LD₅₀ for Northern bobwhite was found to be 226 mg/kg. Lesions observed at necropsy, primarily associated with necrosis in the esophagus and crop, would indicate a “point of entry” effect of the test substance. Based on the results of this study, the LD₅₀ for Northern bobwhite was found to be 226 mg/kg and the no mortality level was 78 mg/kg.

Description of key information

A key study and two supporting studies are available to assess the toxicity to birds. All studies were conducted according to US EPA FIFRA Guidelines and were GLP compliant. An acute oral toxicity test for Bardap 26 was carried out using northern Bobwhite and information from two studies on the dietary toxicity of DDAC to northern bobwhite and mallard are also available.
In the key study, lesions observed at necropsy, primarily associated with necrosis in the esophagus and crop, would indicate a “point of entry” effect of the test substance. Based on the results of this study, the LD50 for Northern bobwhite was found to be 226 mg/kg and the no mortality level was 78 mg/kg. In the supporting study, there was reduction in bodyweight gains for

the birds in the 3160 and 5620 ppm dose groups and no apparent effect on feed consumption. Based on concentration-effect relationship observed, the LC50 was found to be greater than 5620 ppm and the no-observed-effect concentration (NOEC) was 1780 ppm. In the second supporting study, the Mallard duck (Anas platyrhynchos) was exposed to the test material Bardac 2280. Based on concentration-effect relationship observed, the LC50 was found to be greater than 5620 ppm and the no-observed-effect concentration (NOEC) was 562 ppm.

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:

226 mg/kg food

Additional information

Study from which key value was derived:

In a study conducted in accordance with US EPA FIFRA Guideline 71-1, Northern Bobwhite (Colinus virginianus) were exposed to the test material, N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate (Bardap 26), for 21 days, at concentrations of 0, 28, 47, 78, 130, 216, 360 and 600 mg/kg. A vehicle control of deionised water was also used. Male and female test animals were used, with 10 animals (5 males and 5 females) per test concentration and vehicle control. Mortality and signs of clinical toxicity were observed twice daily and bodyweight and estimated feed consumption were measured on Days 0, 3, 7 and 14 and 21 of the test. Under the conditions of this study, the acute oral LD50 for Northern bobwhite was found to be 226 mg/kg. Lesions observed at necropsy, primarily associated with necrosis in the esophagus and crop, would indicate a “point of entry” effect of the test substance. Based on the results of this study, the LD50 for Northern bobwhite was found to be 226 mg/kg and the no mortality level was 78 mg/kg.

 

Supporting studies:

 

In a study conducted in accordance with U.S. EPA FIFRA Guideline 71-2, Northern bobwhite (Colinus virginianus) were exposed to the test substance, Bardac 2280, for 5 days, with 3 days post-exposure observations recorded. The test animals were exposed orally, via the diet, at concentrations of 0, 562, 1000, 1780, 3160 and 5620 ppm. Ten chicks per group were exposed to the test substance in the diet. There were four control groups of ten chicks each, each receiving basal diet. Mortality and signs of clinical toxicity were observed twice daily during the 3 day post-exposure period. Body weights by group were measured at the initiation of the test, on Day 5 and at test termination on Day 8. Average estimated feed consumption was determined for the exposure period and for the post-exposure observation period. Mortality,loss of coordination, lethargy, ruffled appearances and reduction in body weight gains. No deaths occurred in the 4 control groups or at Didecyldimethylammonium Chloride concentrations below 5620 ppm. One mortality occurred on Day 5 at 5620 ppm and was considered to be treatment related. There was reduction in bodyweight gains for the birds in the 3160 and 5620 ppm dose groups and no apparent effect on feed consumption. Based on concentration-effect relationship observed, the LC50 was found to be greater than 5620 ppm and the no-observed-effect concentration (NOEC) was 1780 ppm.

 

In a study conducted in accordance with U.S. EPA FIFRA Guideline 71-2, the Mallard duck (Anas platyrhynchos) was exposed to the test material Bardac 2280 at concentrations of 0, 562, 1000, 1780, 3160 and 5620 ppm for a 5 day exposure period. Post- exposure observations were conducted for a further 3 days, where mortality, clinical signs of toxicity, body weight and food consumption were monitored and recorded. Control test animals were also used and were administered basal diet. The method of dosing was orally,via feed. Based on concentration-effect relationship observed, the LC50 was found to be greater than 5620 ppm and the no-observed-effect concentration (NOEC) was 562 ppm.