Freitag, 26. Februar 2016

Toxicity to birds 001 to .004

Toxicity to birds.001

Administrative data

Purpose flag:
key study
Study result type:
read-across from supporting substance (structural analogue or surrogate)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
Study generated according to generally valid and
internationally accepted testing guideline and performed
under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 206 (Avian Reproduction Test)
GLP compliance:
yes (incl. certificate)
Test type:
reproduction toxicity

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across):
no
Test material identityopen allclose all
Details on test material:
Purity: 99.66%
Analytical monitoring:
yes
Vehicle:
no
Details on preparation and analysis of diet:
- Vehicle, solvent: No
- Procedure: A concentrated premix was made from which further premixes were made for each dose level. Appropriate premixes were mixed with a volume of basal diet overnight and mixed with a Winkworth tumble mixer.

Test organisms

Test organisms (species):
Colinus virginianus
Details on test organisms:
Bobwhite quail (Colinus virginianus)
- Supplier: Monkfield Nutrition, Hertfordshire, UK
- Wild caught: No
- Age/size/weight: approx. 6 months
- Feeding: adults: meal; chicks: chick crumbs
- Feeding during test: Yes

Study design

Limit test:
no
Total exposure duration:
154 d
Post exposure observation period:
- Pretreatment: acclimatisation period of approx. 10 weeks. 2 weeks of pretreatment when untreated basal diet is given.
Nominal and measured doses / concentrations:
- Nominal/measured concentrations: 0, 100, 300 and 1000 ppm (measured concentrations were within 80% of the nominal, therefore nominals
are used)
- Diets were analysed on three occasions.
Details on test conditions:
- Test type: Dietary administration
- Housing: For adults tiered cages of stainless steel mesh, measuring approx. 0.38 x 0.39 x 0.25 m, with a drinker and a food hopper and had a
sloping floor with an egg catcher. Chicks were housed separately from adults in floor pens. Additionally infra red lamps were provided as heat
source.
- Number of replicates, individuals per replicate: 20 replicates, each replicate consisted of 1 male and 1 female
- Collection of eggs: eggs were collected daily and stored at 16 +/- 2 °C. At the end of each week eggs were removed from storage and held at
room temperature for at least 12 hours. Then they were transferred to an incubator at 37.5 +/- 1.5 °C and 50-70% relative humidity. On day 21 they were transferred to the hatcher for 2-3 days at 35.5-38.5 °C and 55-75% relative humidity.
- Test temperature: adults: 21 +/- 2 °C, on 3 occasions it rose to 24 °C; chicks: 19.9-24 °C
- Humidity: 45-67%
- Ventilation: 15-20 air changes per our
- Photoperiod in hours:
Adults
Week of test light dark
Start of week 2 to day 3 of week 5 7 17
Day 4 of week 5 to day 5 of week 5 10 14
Day 6 of week 5 to day 7 of week 5 13 11
Start of week 6 to end of week 8 16 8
Start of week 9 to end of week 9 16.5 7.5
Start of week 10 to termination of test 17 7
Chicks: One room was set at 14 hours light and the other erroneously at 16 hours light. Since half of the birds were in one room and the other half in the other (including the control) it was considered not to have an effect on the integrity or outcome of the test.

DURATION OF THE TEST: 2 weeks of pretreatment, 10 weeks pre-egg production period and 12 weeks egg production period.

Examinations

Details on examinations and observations:
Health, mortality, food consumption, body weight of adults; cracks, abnormalities, egg shell thickness, fertility and hatching of eggs; health,
mortality, body weight, food consumption of chicks.

Results and discussion

Effect levels
Duration:
154 d
Endpoint:
NOEC
Effect level:
300 other: ppm
Basis for effect:
reproductive parameters
Remarks (e.g. 95% CL):
measured
Effects on reproduction:
Observations on eggs (mean):
Treatment No. eggs % eggs damaged Shell
(ppm) per week/ of eggs laid thickness
female (mm)
0 5.4 7.4 0.22
100 5.7 3.4* 0.23
300 5.4 5.6 0.23
1000 1.9* 5.2 0.24*

Observations on embryos and hatchlings (mean):
Treatment % viable embryos % live 3-week
(ppm) of eggs set embryos of viable embryos
0 95 95
100 92 93
300 91 88*
1000 68* 60*

Treatment % normal hatchlings % normal hatchlings
(ppm) of viable embryos of live 3-week embryos
0 82 86
100 82 88
300 77 86
1000 44* 73*

Survivors (mean):
Treatment % 14 -day % 14-day 14-day
(ppm) survivors of survivors of survivors/
normal hatchlings normal eggs laid female
0 74 48 2.6
100 63 44 2.5
300 80 47 2.5
1000 74 19* 0.4*

Bodyweights of chicks (mean):
Treatment On hatching (g) at day 14 (g)
(ppm)
0 7.1 18.1
100 7.0 17.7
300 7.1 17.6
1000 6.6* 16.9


Chick food consumption (mean):
Treatment Days 0-7 Days 8-14
(ppm) (g/bird/day) (g/bird/day)
0 1.7 4.8
100 2.4 5.2
300 1.9 5.2
1000 3.3 4.8

* Significant difference compared to the control
- Effect data: NOEC = 300 ppm (equal to 31.6 mg/kg bw/d)
Further details on results:
- Mortality: 5 birds were found dead during the study, 1 in the control, 1 at 300 ppm and 3 at 1000 ppm. 2 additional birds were killed in the control
and 1 at 300 ppm because of severe injuries. It was unlikely that this was related to treatment.
- Adult body weight: no effects found
- Adult food consumption: unaffected by treatment
- Eggs laid: At 100 ppm the number of eggs increased compared to the control, at 1000 ppm the number decreased compared to the control.
The percentage of damaged eggs was lower in all treatments than in the control.
- Egg shell thickness: significantly greater at 1000 ppm
- Viable embryos: significantly reduced at 1000 ppm. Additionally the percentage of live 3-weeks embryos of viable embryos was significantly
reduced at 300 and 1000 ppm. The results of the hatching data would suggest that the difference at 300 ppm is not biologically significant. This endpoint is not asked for in OECD Guideline 206 and it is not a true endpoint, it is more an intermediate measurement, therefore this result is not taken
into acount for determination of the NOEC.
- Hatchlings: no treatment-related effect evident in the percentage of normal hatchlings of live 3-week embryos. However, the percentage of normal hatchlings of viable embryos was significantly reduced at 1000 ppm. The percentage of 14-day survivors of eggs laid per replicate was significantly
reduced at 1000 ppm. The percentage of 14-day survivors of normal hatchlings was unaffected by treatment.
- Chick body weight: body weight on hatching was significantly reduced at 1000 ppm. However, there were no treatment-related effects on
body-weight after 14 days.
- Chick food consumption: variable, but did not seem to be treatment-related.
- Chick post mortem: no treatment related effects when examined post mortem.
CONTROL:
- Eggs laid: the percentage of damaged eggs was greater than the suggested range in the guideline. All other parameters were acceptable and it is
possible that the difference is due to the strain of birds used. This endpoint does not belong to the criteria for validity of the test and therefore does not have an impact on the validity. 
Reported statistics and error estimates:
Repeated Measures Analysis was used for adult body weight, adult food consumption rate, egg shell thickness, hatched chick weight and chick body weight. Poisson distributed counts was used for eggs laid per treatment, eggs laid per replicate, 14-day survivors per replicate. Logistic regression
was used for eggs damaged of eggs laid, viable embryos of eggs set, live 3-weeks embryos of viable embryos, normal hatchlings of viable embryos, 14-day survivors of normal hatchlings, 14-day survivors of eggs laid.

Applicant's summary and conclusion

Executive summary:
Study title: Sodium chlorate: Assessment to determine the effects on reproduction in the Bobwhite quail (Colinus virginianus)
Guidelines: United States Environmental Protection Agency Pesticide Assessment Guidelines, Subdivision E, Hazard Evaluation: Wildlife and Aquatic Organisms, Series 71-Avian and Mammalian Testing, § 71-4 Avian reproduction test, dated October 1982.
OECD Guideline for testing of chemicals (1984), no 206, entitled "Avian Reproduction Test".
Study No.: K3AK1008
Test item: Sodium chlorate
Batch No.: 1E0103WF
Purity: 99.66 %
Formulation: Technical material
Test species: Bobwhite quail (Colin us virginianus)
Source: Monkfield Nutrition
Test system: Dietary administration.
Treatments: Control (untreated basal diet) and three test item concentrations.
Test item treatment levels: 100 (Group 2),300 (Group 3) and 1000 (Group 4) ppm.
Replicates: 20 replicates per test item treatment and 20 replicates for the control. Each replicate consisting of one male and one female.
Test period: 2 week pre-treatment period, 10 week pre-egg laying treatment period, 12 week egg laying treatment period. Eggs collected over the 12 week period and resulting chicks reared for 14 days.
Results: No treatment related effects were observed in adult bodyweights or food consumption. At termination of the adult phase a higher incidence of liver congestion was seen at post mortem examination in birds treated at 1000 ppm. Statistically significant effects were observed in the following parameters:
Eggs laid (Group 2, increased & 4, decreased)
Eggs laid per female (Group 4 decreased)
Eggs damaged of eggs laid (Group 2 decreased)
Egg shell thickness (Group 4 increased)
Viable embryos (fertile eggs) of eggs set (Group 4 decreased)
Live 3 -week embryos (Day 18 candling) of viable embryos (Groups 3 and 4 decreased)
Normal hatchlings of viable embryos (Group 4 decreased)
14 -day survivors of eggs laid (Group 4 decreased)
14 -day survivors per female (Group 4 decreased)
Chick bodyweights at hatching (Group 4 decreased)
Conclusion: Under the conditions of this study the NOEC was considered to be 300 ppm.
Validity criteria fulfilled:
yes
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