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Ecotoxicological information

Toxicity to birds

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Administrative data

Endpoint:
long-term toxicity to birds: reproduction test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study does not strictly follow the guideline recommendations and does not give results for all the endpoints (no 14-d survival of hatchlings followed). However, the results are numerous and consistent.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Responses of adult Mallard ducks to ingested South Louisiana crude oil
Author:
Coon, N.C., Dieter, M.P.
Year:
1981
Bibliographic source:
Environmental Research 24: 309-314

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 850.2300 (Avian Reproduction Test)
Deviations:
yes
Remarks:
Only 1 concentration tested; 8 pens instead of 12; longer final phase; no 14-d survival of hatchlings observed
Principles of method if other than guideline:
Guideline principles
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Paraffin mixture, Paraffin
- Substance type: Petroleum product
- Physical state: Liquid
- Composition of test material, percentage of components: equal parts by weight of tridecane, pentadecane, hexadecane, heptadecne, octadecane, 2,2,4,6,6-pentamethyl heptane, 2,2,4,4,6,8,8-heptamethyl nonane, 2,6,10,14- tetramethyl pentadecane and decahydronaphthalene
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No test surrogate material
Dose method:
other: Food available ad libitum
Analytical monitoring:
not specified
Vehicle:
no
Details on preparation and analysis of diet:
DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
- Food composition: Food consisted of duck developer mash (not less than 14.5% crude protein, 2.75% crude fat, and 7% crude fiber) for 2 months and then duck breeder mash (not less than 17% crude protein, 3% crude fat, and 6% crude fiber).

- Nominal concentration : 1.0% of paraffin mixture

Test organisms

Test organisms (species):
Anas platyrhynchos
Details on test organisms:
TEST ORGANISM
- Common name: Mallard duck
- Source: Commercial
- Age at test initiation (mean and range, SD): 5 months
- Weight at test initiation (mean and range, SD): No data
- Sexes used: Males and females

Study design

Limit test:
yes
Total exposure duration (if not bolus):
26 wk
Post exposure observation period:
No post-exposure observation period
No. of animals per sex per dose and/or stage:
8
Control animals:
yes, concurrent no treatment
Nominal and measured doses / concentrations:
Nominal concentration : 1.0% parffin mixture in food
Details on test conditions:
ACCLIMATION
- Acclimation period: 2 weeks
- Acclimation conditions (same as test or not): same as test
- Feeding: Duck developper mash (not less tahn 14.5% crude protein, 2.75% crude fat, and 7% crude fiber), ad libitum
- Health (any disease or mortality observed): No data
- Fasting period before study: No fasting period


PEN SIZE AND CONSTRUCTION MATERIALS
- Description: 90 x 90x 60-cm vinyl coated wire pens
- Floor covering: No data
- Caging: pairs

NO. OF BIRDS PER REPLICATE
- For negative control: 1 male / 1 female
- For treated: 1 male / 1 female

NUMBER OF REPLICATES
- For negative control: 8
- For treated: 8

TEST CONDITIONS (range, mean, SD as applicable)
- Photoperiod: Artificial day length was set at 10 hrs for the first 2 months, then increased by 2 hrs at weekly intervals to 16 hrs where it was maintained.


Examinations

Details on examinations and observations:
MORTALITY / CLINICAL SIGNS
- Time schedule for examinations:
- Remarks:


BODY WEIGHT
- Time schedule for examinations: Monthly
- Remarks:


FOOD CONSUMPTION (if feeding study)
- Time schedule for examinations:No data
- Remarks:


PATHOLOGY
All birds were sacrificed after 26 weeks on treatement. Protions of the kidney, liver, and gonad were preserved in 10% formalin and later embedded in paraffin, sectioned and stain with hematoxylin-eosin for microscopic observation.


ORGAN WEIGHTS
- Organs: Liver, spleen, adrenal gland and gonad (oviduct or testes)
- Remarks: organs were weight at the end of the experiment after a 26-week exposure


OTHER:
At each weighing (monthly intervals), 3-ml blood samples were drawn from the alar vein for haematological (hematocrit and hemoglobin determinations) and biochemical (plasma concentrations of sodium, potassium, cholesterol, and triglycerides; plasma enzyme activities: glutamic oxalacetic transaminase- GOT, lactate deshydrogenase - LDH, alpha-hydroxybutiric acid deshydrogenase - HBDH, ornithine carbamyl transferase - OCT) investigations.
Portions of selected tissues were frozen for petroleum hydrocarbon analyses.
Details on reproductive parameters:
The following parameters were examined per parental pen per week:
- Eggs laid
- Eggshell thickness or eggshell strength
- Eggs fertile
- Embryos viable
- Normal hatchlings
- Abnormal hatchlings


OTHER:
Content of the eggs were saved for later petroleum hydrocarbon analyses.
Reference substance (positive control):
no

Results and discussion

Effect levelsopen allclose all
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
body weight
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
organ weights
Remarks:
Liver
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
organ weights
Remarks:
Spleen
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
organ weights
Remarks:
Adrenal gland
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
organ weights
Remarks:
Gonads (ovary or testis)
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
reproductive parameters
Remarks:
Eggs laid
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
reproductive parameters
Remarks:
Fertility
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
reproductive parameters
Remarks:
Hatchability
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
reproductive parameters
Remarks:
Eggshell thickness
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
pathology
Remarks:
Liver histopathology
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
pathology
Remarks:
Kidney histopathology
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
pathology
Remarks:
Gonad (testis or ovary) histopathology
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
pathology
Remarks:
Blood hematocrit and hemoglobin concentration
Duration (if not bolus):
26 wk
Dose descriptor:
other:
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
pathology
Remarks:
Plasma sodium and potassium concentrations
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
pathology
Remarks:
Plasma triglyceride and cholesterol concentrations
Duration (if not bolus):
26 wk
Dose descriptor:
other: NOELR
Effect level:
10 000 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
pathology
Remarks:
Plasma enzyme activity: GOT, HBDH and OCT
Repellency factors (if applicable):
No data
Mortality and sub-lethal effects:
For details see Tables no. 1 and 2
MORTALITY
No mortality observed

CLINICAL SIGNS
- Results: No difference between exposed and control birds


ABNORMAL BEHAVIOUR
- Results: No abnormal behaviour


BODY WEIGHT (see Table 1)
- Results: No difference between exposed and control birds


FOOD CONSUMPTION (if feeding study)
- Results: No difference between exposed and control birds


PATHOLOGY
- Results: No difference between exposed and control birds

ORGAN WEIGHTS
- Results: No difference between exposed and control birds


HISTOPATHOLOGY
- Results: No difference between exposed and control birds


Effects on reproduction:
See table 2
Results with reference substance (positive control):
No reference substance
Further details on results:
When activities of plasma enzymes originating from the liver (GOT), Kidney (OCT), or heart (HBDH) were compared between treated and control birds, there were no obvious differences due to treatment. In addition plasma glyceride and cholesterol concentrations did not change with treatment, nor did variables that can be altered by dehydration, e.g., hematocrit, hemoglobin, sodium, potassium and total protein in the plasma.
Reported statistics and error estimates:
According to the statistical test used for evaluating significance of the results, there was no statistical difference between treated and control birds for any of the parameters analysed (p<0.05).

Any other information on results incl. tables

Table 1. Weights of whole bodies and organs of adult Mallard ducks after 26 weeks on diet contaminated with paraffin mixture

 

Treatment

Sex

Body weight (g)

Organ weights (g/1000g body weight)

Liver

Spleen

Gonad

Control

Males

1339 ± 66.8

22.1 ± 0.86

0.49 ± 0.04

26.0 ± 4.16

Females

1274 ± 26.3

41.5 ± 3.5

0.66 ± 0.06

16.6 ± 4.86

1.0% Paraffin

Males

1268 ± 69.8

21.7 ± 0.91

0.47 ± 0.05

24.3 ± 4.09

Females

1186 ± 40.9

43.6 ±5.44

0.56 ± 0.06

25.2 ± 5.2

 

 

 

Table 2. Egg production in adult Mallard ducks after 26 weeks on diet contaminated with paraffin mixture

 

Treatment

Number of total eggs laid

Number of Eggs laid / hen

Number of Eggs laid / hen / week

Control

615

76.9

5.1

1.0% paraffin

617

77.1

5.1

 

Applicant's summary and conclusion

Conclusions:
No long-term toxicity of paraffin was observed neither to adult Mallard ducks, neither to their eggs.
Executive summary:

Adult Mallard ducks were exposed to diet contaminated with 1.0% paraffin mixture (equal parts of tridecane, pentadecane, hexadecane, heptadecane, octadecane, nonadecane, 2,2,4,6,6-pentamethylheptane, 2,2,4,4,6,8,8-heptamethylnonane, and decahydronaphthalene) for 26 weeks. No statistical differences were seen between treated and control duck body weight, organ (liver, kidney, spleen) weights, blood parameters (hematocrit, hemoglobin, plasma sodium, potassium, cholesterol and triglycerides, plasma enzyme activities glutamic oxalacetic transaminase - GOT, lactated deshydrogenase - LDH, alpha-hydroxybutiric acid dehydrogenase - HBDH, and orinithine carbamyl transferase - OCT). The exposure had no effect on the number of laid eggs, neither on eggshell thickness, fertility and egg viability.