Registration Dossier

Administrative data

Endpoint:
toxicity to birds
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non guideline study published in peer reviewed literature with minor restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was fed to mallard ducklings in concentrations of 0.5% and 5.0% of the diet from hatching to 18 weeks of age.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No. 2 fuel oil
Dose method:
feed
Analytical monitoring:
not specified
Vehicle:
no
Details on preparation and analysis of diet:
No. 2 fuel oil was mixed in 0.5% and 5% concentration in commercial duck started mash. This was fed ad libitumto the ducks for 8 weeks. The ducks were then fed with similar concentrations of test substance in developer mash for the final 10 weeks.

Test organisms

Test organisms (species):
Anas platyrhynchos
Details on test organisms:
Mallard eggs were obtained from Whistling Wings (Hanover, Ill, USA). The ducklings were hatched in house.

Study design

Limit test:
yes
Total exposure duration (if not bolus):
18 wk
Post exposure observation period:
Not reported
No. of animals per sex per dose and/or stage:
36 animals. 18 males and 18 females. 36 control animals were also used with a 1:1 ratio of males to females.
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
Nominal dose.
Details on test conditions:
Four animals were assigned to each pen (2 male and 2 female). The animals had unlimited access to water. The test temperature and photoperiod were not reported.

Examinations

Details on examinations and observations:
All birds were weighed once a week for 18 weeks. Other weekly measurements taken were culmen length, tarsal length, wing length and length of the ninth primary. At 9 d of age the ducklings were tested for their response to a frightening stimulus (rotating black and white axle which created a noise) using the method of Heinz, 1975 and 1976. The distance of retreat from the stimulus was measured.At 16 weeks of age the ducks were tested for open field behaviour. The movement of groups of ducks in a 3 X 3 m room marked into 1 X 1 m squares was observed for 5 minutes. Movement was recorded as the number of line crosses on an individual basis and square movements when at least 3 bird moved from one square into another.2 ml blood samples were taken at 6, 12 and 18 weeks of age. Blood samples were analysed for Sodium ions, potassium ions, cholestrol, triglycerides and plasma enzymes.Liver and spleen weights were recorded and microscopic analysis was performed on tissue sections (heart, intestinal loop, gonads). The age of the animals at organ harvesting was not reported but is assumed to be 18 weeks.
Details on reproductive parameters:
Not reported
Reference substance (positive control):
not specified

Results and discussion

Effect levels
Duration (if not bolus):
18 wk
Dose descriptor:
other: NOAEL
Effect level:
5 000 other: ppm
Conc. / dose based on:
test mat.
Basis for effect:
other: growth
Mortality and sub-lethal effects:
There was no mortality related to ingestion of No. 2 fuel oil. There were significant differences (alpha < 0.01) in sex and treatments for 5 growth parameters at 18 weeks of age between the test and control groups. Duckings fed on 5% oil exhibitedsignificantly (alpha < 0.05) reduced avoidance behaviour when compared to the control animals and animals fed on 0.5% oil. In the open field test, the animals fed on 5% oil were significantly (alpha < 0.05) more active than the other groups.Morphological examinations showed liver weights were rasied in ducklings fed on 5% oil. Conversely, spleen weights decreased with increasing dietry oil concentration. Increasing oil concentration was related to enhanced enzymatic activity in the plasma, liver and kidney. Subtle morphological differences were also observed between the control and test animal organs. For example, livers of ducks fed on 5% oil showed focal hepatocytic vacuolation to a greater extent than the other groups.
Effects on reproduction:
Effects on reproduction were not investigated.
Results with reference substance (positive control):
Not applicable
Further details on results:
Not applicable
Reported statistics and error estimates:
Multivariate analysis of variance and repeated measures analysis were used to compare sex and growth parameters.

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
Non mortality was observed in ducklings fed no, 0.5 or 5% dietary oil. The growth NOAEL for 18 week old mallard ducks was 5000 ppm.
Executive summary:

Newly hatched Mallard ducklings were fed on feed containing 0, 0.5 or 5% No. 2 fuel oil for 18 weeks. Growth, mortality, behavioural, histological and biochemical investigations were performed to determine the effect of the test substance on the ducklings. Non mortality was observed in ducklings fed no, 0.5 or 5% dietary oil. The growth NOAEL for 18 week old mallard ducks was 5000 ppm. Growth, behavioural, histological and biochemical effects were dose related. This study is considered reliable as it is a non-GLP, non guideline study. It was published in peer reviewed literature, it has minor restrictions in design and/or reporting but is otherwise adequate for assessment.