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EC number: 619-057-3 | CAS number: 94667-33-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to birds
Administrative data
Link to relevant study record(s)
- 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.
- 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.
Reference
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 |
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.
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