Paraffins (petroleum), normal C>10

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

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

C10-C19 Paraffin mix

IUPAC Name:

C10-C19 Paraffin mix

Constituent 2

Reference substance name:

Paraffin mixture

IUPAC Name:

Paraffin mixture

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 single dose):

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 levels

Effect levels 1

Duration (if not single dose):

26 wk

Dose descriptor:

other: NOELR

Effect level:

10 000 mg/kg diet

Conc. / dose based on:

test mat.

Basis for effect:

body weight

Effect levels 2

Duration (if not single dose):

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

Effect levels 3

Duration (if not single dose):

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

Effect levels 4

Duration (if not single dose):

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

Effect levels 5

Duration (if not single dose):

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)

Effect levels 6

Duration (if not single dose):

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

Effect levels 7

Duration (if not single dose):

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

Effect levels 8

Duration (if not single dose):

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

Effect levels 9

Duration (if not single dose):

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

Effect levels 10

Duration (if not single dose):

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

Effect levels 11

Duration (if not single dose):

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

Effect levels 12

Duration (if not single dose):

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

Effect levels 13

Duration (if not single dose):

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

Effect levels 14

Duration (if not single dose):

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

Effect levels 15

Duration (if not single dose):

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

Effect levels 16

Duration (if not single dose):

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.