Raffinates (Fischer-Tropsch), C10-25-branched

Toxicity to birds

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; study published in 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No guideline. The effects on embryonic development are investigated through direct application of the substance on the egg shell. A great number of eggs (65 per dose) were tested, which contributes to make the results statistically valid.

Data source

Reference

Reference Type:

publication

Title:

Embryotoxic effects of crude oil in Mallard ducks and chicks

Author:

Hoffman, D. J.

Year:

1978

Bibliographic source:

Toxicology and Applied Pharmacology 46: 183-190

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Oil is applied on the surface of fertile eggs. Embryonic survival time, teratogenic potential, and growth were evaluated.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

C10-C19 paraffin mixture

IUPAC Name:

C10-C19 paraffin mixture

Details on test material:

- Name of test material (as cited in study report): Paraffin mixture
- Test material composition included equal parts (wt.) of following constituents: decahydronaphthalene (C10), 2,2,4,6,6-pentamethyl heptane (C12), n-pentadecane (C15), n-hexadecane (C16), 2,2,4,4,6,8,8-heptamethyl nonane (C16), n-heptadecane (C17), n-octadecane (C18), nonadecane (C19), 2,6,10,14-tetramethyl pentadecane (C19)
- Physical state: Liquid

Dose method:

other: application onto egg shell

Analytical monitoring:

no

Vehicle:

no

Details on preparation and analysis of diet:

No diet

Test organisms

Test organisms (species):

Anas platyrhynchos

Details on test organisms:

TEST ORGANISM
- Common name: Mallard duck
- Source: Commercial hatcheries: Whistling WIngs, Hanover, Ill., and Truslow Farms, Chestertown, Md.
- Age at test initiation (mean and range, SD): Eggs (72hr of development)

Study design

Limit test:

yes

Total exposure duration (if not single dose):

18 d

Post exposure observation period:

No post-exposure period

No. of animals per sex per dose and/or stage:

65 eggs; see results for sex ratio

Control animals:

yes, concurrent no treatment

Nominal and measured doses / concentrations:

5µL per egg

Details on test conditions:

SUBSTANCE APPLICATION:
5µL of paraffin mixture were applied by microliter pipet to the shell surface just below the air space of upright eggs (72 hrs of development) and permitted to spread freely

NO. OF EGGS
- For negative control: 65
- For treated: 65

TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: 37.5°C
- Relative humidity (%): 70

Examinations

Details on examinations and observations:

MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: daily
- Remarks: all eggs were candled daily to determine mortality, and dead embryos were removed and examined.

EMBRYONIC WEIGHT
- Time schedule for examinations: All remaining eggs were opened on the 18th day of development and the embryos were removed and weighed.
- Remarks:

PATHOLOGY
- One half of the embryos were defeathered and placed in Bouin's solution for fixation and subsequent examination of soft tissues by the sectioning technique of Wilson (1965) and by dissection.
- The other half were cleared and staiend with alizarine red S according to the method described by Karnofsky (1965) for squeletal examination.

OTHER:
When removed from the shell, sex-ratios, crown-rump lengths, and beak lengths were recorded.

Details on reproductive parameters:

The following parameters were examined per egg:
- Embryos viable
- Clinical signs of toxicity, abnormalities and mortality

OTHER:
- Embryonic growth: embryo weight, crown-rump length, beak length
- Sex ratio

Reference substance (positive control):

no

Results and discussion

Effect levels

Effect levels 1

Duration (if not single dose):

18 d

Dose descriptor:

other: NOELR

Effect level:

5 other: µL/egg

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Remarks:

Embryonic mortality

Effect levels 2

Duration (if not single dose):

18 d

Dose descriptor:

other: NOELR

Effect level:

5 other: µL/egg

Conc. / dose based on:

test mat.

Basis for effect:

reproductive parameters

Remarks:

Embryo weight

Effect levels 3

Duration (if not single dose):

18 d

Dose descriptor:

other: NOELR

Effect level:

5 other: µL/egg

Conc. / dose based on:

test mat.

Basis for effect:

reproductive parameters

Remarks:

Sex ratio

Effect levels 4

Duration (if not single dose):

18 d

Dose descriptor:

other: NOELR

Effect level:

5 other: µL/egg

Conc. / dose based on:

test mat.

Basis for effect:

other: Development: crown-rump length

Effect levels 5

Duration (if not single dose):

18 d

Dose descriptor:

other: NOELR

Effect level:

5 other: µL/egg

Conc. / dose based on:

test mat.

Basis for effect:

other: Development: beak length

Repellency factors (if applicable):

Not applicable

Mortality and sub-lethal effects:

For details on mortality and sub-lethal effects see Table 1.

Effects on reproduction:

For effects on embryo development see Table 1.

Reported statistics and error estimates:

Embryonic weights, crown-rump lengths, and beak lengths were compared by one-way analysis of variance and Duncan's multiple range test. Survival data, sex distribution and numbers of embryos with one or more defects were compared by squared-chi analysis.
No statistical difference ws found between treated and control eggs for any invetigated parameter.

Any other information on results incl. tables

Table 1. Effects of paraffin mixture (5 µL/egg) on Mallard duck embryos

 

	Control	Paraffin
Number treated	65	65
Percentage survival (Days 3-18)	97	94
Sex ratio, M:F	45:55	44:56
Embryonic Weight (g)
Male	15.72 ± 1.78	16.34 ± 1.49
Female	15.75 ± 2.03	15.98 ± 1.58
Combined	15.74 ± 1.90	16.14 ±1.54
Crown-rump length (mm)
Male	84.1 ± 3.7	84.9 ± 4.0
Female	82.7 ± 3.7	83.4 ± 3.0
Combined	82.8 ± 3.7	84.1 ± 3.5
Beak length (mm)
Male	13.2 ± 0.9	13.3 ± 0.5
Female	13.1 ± 0.6	12.9 ± 0.6
Combined	13.1 ± 0.7	13.1 ± 0.6
Percentage that were abnormal survivors	4.8	3.3

Applicant's summary and conclusion

Validity criteria fulfilled:

not applicable

Conclusions:

Mallard duck eggs were coated with 5ul of a paraffin mixture (equal parts (wt.) of decahydronaphthalene (C10), 2,2,4,6,6-pentamethyl heptane (C12), n-pentadecane (C15), n-hexadecane (C16), 2,2,4,4,6,8,8-heptamethyl nonane (C16), n-heptadecane (C17), n-octadecane (C18), nonadecane (C19), and 2,6,10,14-tetramethyl pentadecane (C19)) for 18 days.
There were no effects on embryonic survival and weight, sex ratio, and development (crown-rump and beak lengths) in eggs that had the paraffin mixture applied to the shell surface in comparison to control eggs.

Executive summary:

Mallard duck eggs were coated with 5ul of a paraffin mixture (equal parts (wt.) of decahydronaphthalene (C10), 2,2,4,6,6-pentamethyl heptane (C12), n-pentadecane (C15), n-hexadecane (C16), 2,2,4,4,6,8,8-heptamethyl nonane (C16), n-heptadecane (C17), n-octadecane (C18), nonadecane (C19), and 2,6,10,14-tetramethyl pentadecane (C19)) for 18 days.

There were no effects on embryonic survival and weight, sex ratio, and development (crown-rump and beak lengths) in eggs that had the paraffin mixture applied to the shell surface in comparison to control eggs.