Registration Dossier

Ecotoxicological information

Toxicity to birds

Currently viewing:

Administrative data

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:
1999-02-02 - 1999-03-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to
Guideline:
other: no guideline available
Principles of method if other than guideline:
Acute oral toxicity test was conducted for a short period in japanese quails in order to study the possible toxic effect of the product Ferbam. The product was utilized pure, put into gelatin capsules and administered orally to quails with age of 16 weeks in the dose of2,000 mg/kg of body weight. The birds were observed for mortality, behavioral changes, external clinical symptoms and presence of anatomical alterations.
GLP compliance:
no
Specific details on test material used for the study:
originally in the solid form was utilized pure, accurately weighted then placed in gelatin capsules
Dose method:
capsule
Analytical monitoring:
not specified
Vehicle:
yes
Remarks:
gelatine capsules
Test organisms (species):
Coturnix coturnix japonica
Details on test organisms:
The test was carried out with japanese quail (Coturnix coturnix japonica). The age of the test birds were at least 16 weeks old when the test initiated. The birds were healthy and of an uniform size and weight, and had never been used in another test or submitted to any treatment. Individual body weights were measured at the beginning and at the end of the study, males weighting 120 to 141 g and female birds 125 to 148 g, at the beginning of the test.
Limit test:
yes
Total exposure duration (if not bolus):
15 d
Post exposure observation period:
minimum of 14 days after dosing
No. of animals per sex per dose and/or stage:
5
Control animals:
yes
Nominal and measured doses / concentrations:
nominal: 2000 mg/kg of body weight
Details on test conditions:
The birds were preconditioned to test facilities for at least 15 days prior to the beginning of the experiment Pen conditions were kept at temperature ranging from 25 to 28°C, relative humidity 30-70%, 10 to 15 air changes per room per hour and photoperiod of 10-hour light/ 14-hour dark lighting regime (fluorescent light). Ten birds were used per dosage (five of each sex) randomly distributed in cages with the maximum of five birds per cage.

Feed was withheld from all birds for at least 15 hours prior to oral dosing. After administration of the test material, the birds had free access to feed (commercial brand GUABI ration) and water. Food consumption was monitored for treated and control birds.

Except in cases where no birds survive, the observation period was always a minimum of 14 days after dosing.
Details on examinations and observations:
The birds were observed for mortality, behavioral changes, external clinical symptoms and presence of anatomical alterations. The birds were weighted at the beginning and at the end of test. Gross necropsy was carried out in any bird that died during the test, and in all the birds by the end of the experiment. Routine necropsy was done in the GI tract, liver, kidneys, heart and lung.
Details on reproductive parameters:
not specified
Reference substance (positive control):
no
Key result
Duration (if not bolus):
14 d
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Mortality and sub-lethal effects:
Average death time:
No deaths were observed in the birds.
Effects on reproduction:
not applicable
Results with reference substance (positive control):
not applicable
Further details on results:
Behavioral changes
No behavioral changes were observed in the birds.

Clinical symptoms:
No clinical symptoms were observed in the birds.

Fecal material and urine
No alterationsin the fecal material and urine were observed in the test animals

see 'Any other information on results incl. tables!

Reported statistics and error estimates:
no statistical analysis was carried out

Number of deaths:

- Male       - Dose 1 (2000 mg/kg): 0

- Control (0.00 mg/kg): 0

- Female:   - Dose 1: 0

- Control: 0

- Total:       - Dose 1: 0

- Control: 0

Median Lethal Dose (LD50):

- Male:       >2000 mg/kg

- Female:    >2000 mg/kg

- Total:       >2000 mg/kg

Confidence interval at 5 %:

- Male:       not calculated

- Female:    not calculated

- Total:       not calculated

Gross necropsy

Dead birds:

- Respriatory system: NSF

- Ciculatory system: NSF

- Central nervous system: Not searched

- Digestive system: NSF

- Genital and urologic systems: NSF

- Another (liver and pancreas): NSF

Surviving birds:

- Respriatory system: NSF

- Ciculatory system: NSF

- Central nervous system: Not searched

- Digestive system: NSF       

- Genital and urologic systems: NSF

- Another (liver and pancreas): NSF

NSF = No Specific Findings

Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, the product Ferbam applied orally to japanese quails showed a Median Lethal Dose (LD50) for male and female japanese quails higher than 2,000 mg/kg. The lower limit of the confidence interval of the LD50 for both sexes (male and female) was higher than 2,000 mg/kg. No other local or general alterations were observed in the animals.
Executive summary:

Acute oral toxicity test was conducted for a short period in japanese quails in order to study the possible toxic effect of the product Ferbam. The product was utilized pure, put into gelatin capsules and administered orally to quails with age of 16 weeks in the dose of2,000 mg/kg of body weight. The birds were observed for mortality, behavioral changes, external clinical symptoms and presence of anatomical alterations. Median Lethal Dose (LD50) was higher than 2,000 mg/kg of body weight.

Description of key information

Acute oral toxicity test was conducted for a short period in japanese quails in order to study the possible toxic effect of the product Ferbam. Median Lethal Dose (LD50) was higher than 2,000 mg/kg of body weight.

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:
2 000 mg/kg food

Additional information

Value above is LD50, not LC50!

Key: dos Santos, 1999

Acute oral toxicity test was conducted for a short period in japanese quails in order to study the possible toxic effect of the product Ferbam. The product was utilized pure, put into gelatin capsules and administered orally to quails with age of 16 weeks in the dose of2,000 mg/kg of body weight. The birds were observed for mortality, behavioral changes, external clinical symptoms and presence of anatomical alterations. Median Lethal Dose (LD50) was higher than 2,000 mg/kg of body weight.

Supporting information: Fink, 1973a

The study was conducted according to "A GUIDELINE FOR EVALUATION OF SUBACUTE TOXICITY OF ECONOMIC POISONS TO AVIAN SPECIES - DIETARY LC50 - 8-DAY PROTOCOL" (Finney, D. J. Probit Analysis, 2nd Edition, Cambridge University Press 318 pp (1952)) but not under GLP.

The test chemical and dieldrin used in the positive control diet shall be dissolved in edible-grade corn oil prior to incorporation in the rations. If the test material is incompatible with, or insufficiently soluble in corn oil, propylene glycol may be used as the solvent. Concentration of toxicant in the solution shall be adjusted so that the addition of 2 parts (by weight) of this solution to 98 parts of the standard game bird ration will result in the desired concentration (ppm) of toxicant in the finished diet. The standard game bird ration is to be fed to the negative control groups at all times, and to the positive control and test groups during the pretreatment (acclimation) and post-treatment (observation) periods. It shall consist of 2 parts solvent and 98 parts of the standard ration.

The acute LC50 of ferbam is estimated to be greater than 4640 ppm.

Supporting information: Fink, 1973b

The study was conducted according to "A GUIDELINE FOR EVALUATION OF SUBACUTE TOXICITY OF ECONOMIC POISONS TO AVIAN SPECIES - DIETARY LC50 - 8-DAY PROTOCOL" (Finney, D. J. Probit Analysis, 2nd Edition, Cambridge University Press 318 pp (1952)) but not under GLP.

The test chemical and dieldrin used in the positive control diet shall be dissolved in edible-grade corn oil prior to incorporation in the rations. If the test material is incompatible with, or insufficiently soluble in corn oil, propylene glycol may be used as the solvent. Concentration of toxicant in the solution shall be adjusted so that the addition of 2 parts (by weight) of this solution to 98 parts of the standard game bird ration will result in the desired concentration (ppm) of toxicant in the finished diet. The standard game bird ration is to be fed to the negative control groups at all times, and to the positive control and test groups during the pretreatment (acclimation) and post-treatment (observation) periods. It shall consist of 2 parts solvent and 98 parts of the standard ration.

The acute LC50 of ferbam is 2940 ppm.