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EC number: 921-535-4 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
Toxicity to birds
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of 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.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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
- 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 (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 - 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.
- 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
- 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
- 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
- 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
- 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
- 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)
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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 sodium and potassium concentrations
- 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
- 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).
- 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.
- Endpoint:
- long-term toxicity to birds
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study does not follow a guideline, but it is reliable because the results are numerous and consistent.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The ducks are fed on a commercial breeder mash containing the test substance for 7 months. They are weighed monthly and blood is taken up from the brachial vein to follow liver function using indocyanin green dye clearance technique (Ketterrer, S. G., Wiegand, B. D., Rapaport, E., 1960. Hepatic uptake and biliary excretion of indocyanin green and its use in estimation of hepatic blood flow in dogs. American Journal of Physiology 199: 481-484).
- GLP compliance:
- not specified
- 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:
- feed
- Analytical monitoring:
- not specified
- Vehicle:
- no
- Details on preparation and analysis of diet:
- Commercial breeeder mash containing 1% of the paraffin mixture
- Test organisms (species):
- Anas platyrhynchos
- Details on test organisms:
- TEST ORGANISM
- Common name: Mallard duck
- Source: no data
- Age at test initiation (mean and range, SD): no data
- Weight at test initiation (mean and range, SD): 1200-1300 g
- Sexes used: Males - Limit test:
- yes
- Total exposure duration (if not single dose):
- 7 mo
- Post exposure observation period:
- No post exposure period
- No. of animals per sex per dose and/or stage:
- 12
- Control animals:
- yes, concurrent no treatment
- Nominal and measured doses / concentrations:
- Nominal concentration in food: 1 %
- Details on test conditions:
- ACCLIMATION
- Acclimation period: 1 month
- Acclimation conditions (same as test or not): Same as test
- Feeding: commercial breeder mash ad libitum
- Health (any disease or mortality observed): no data
- Fasting period before study: no fasting period
PEN SIZE AND CONSTRUCTION MATERIALS
- Description: vinyl coated wire pens, 90 x 90 x 60 cm
- Floor covering: no data
- Caging: pairs
- air-conditioned building with controlled lighting and running water
NO. OF BIRDS PER REPLICATE
- For negative control: 2
- For treated: 2
NO. OF REPLICATES PER GROUP
- For negative control: 6
- For treated: 6
TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: no data but controlled (air-conditioned)
- Photoperiod: 12D:12L
- Details on examinations and observations:
- MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: Monthly
BODY WEIGHT
- Time schedule for examinations: monthly
PATHOLOGY
- ICG test performed monthly
- Blood parameters (Plasma sodium and potassium, glutamic oxaloacetic transaminase - GOT): monthly
ORGAN WEIGHTS
- Organs: Liver, testes - Details on reproductive parameters:
- No reproductive parameters studied
- Reference substance (positive control):
- no
- Duration (if not single dose):
- 7 mo
- 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 single dose):
- 7 mo
- Dose descriptor:
- other: NOELR
- Effect level:
- 10 000 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- other: ICG test
- Duration (if not single dose):
- 7 mo
- 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 single dose):
- 7 mo
- Dose descriptor:
- other: NOELR
- Effect level:
- 10 000 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- organ weights
- Remarks:
- testes
- Duration (if not single dose):
- 7 mo
- Dose descriptor:
- other: NOELR
- Effect level:
- 10 000 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- pathology
- Remarks:
- Blood hematocrit
- Duration (if not single dose):
- 7 mo
- Dose descriptor:
- other: NOELR
- Effect level:
- 10 000 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- pathology
- Remarks:
- Plasma sodium and potassium
- Duration (if not single dose):
- 7 mo
- Dose descriptor:
- other: NOELR
- Effect level:
- 10 000 mg/kg diet
- Conc. / dose based on:
- test mat.
- Basis for effect:
- pathology
- Remarks:
- Plasma GOT
- Repellency factors (if applicable):
- Not applicable
- Mortality and sub-lethal effects:
- MORTALITY
No mortality
ABNORMAL BEHAVIOUR
- Results: No abnormal behaviour
BODY WEIGHT
- Results: No statistical difference between control and treated duck body weights (p<0.05)
PATHOLOGY
- Results: There was no statistical difference between control and treated duck for any of the investigated parameters
ORGAN WEIGHTS
- Results: see table 1
- Effects on reproduction:
- Not applicable
- Results with reference substance (positive control):
- Not applicable
- Further details on results:
- No further details
- Reported statistics and error estimates:
- The data were analyzed using a two-way analysis of variance for repeated measures. Separation of mean differences was performed using Duncan's multiple range test.
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- The paraffin mixture is not toxic to Mallard duck.
- Executive summary:
The indocyanine green dye clearance test (ICG) for hepatic function was determined in mallard ducks before and during the chronic ingestion (7 months) of representative paraffinic petroleum hydrocarbon mixture (tridecane, pentadecane, hexadecane, heptadecane, octadecane, nonadecane, 1,1,4,6,6-pentamethylheptane, 2,2,4,4,6,8,8-heptamethylnonane, 2,6,10,14-tetramethylpentadecane, decahydronaphthalene).
No mortality nor visible symptoms of toxicity occurred in any of the tests. There was no statiticaly significant difference between control and treated duck weights. There was no change in ICG, nor in plasma sodium, potassium and GOT activity. It is concluded that paraffin mixture is not toxic to Mallard duck.
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- 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.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- reference to same study
- 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 are evaluated.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
No surrogate test material - Dose method:
- other: application onto egg shell
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and analysis of diet:
- No diet
- 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) - Limit test:
- no
- 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 per dose. For sex ratio, see results.
- 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 - 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
- 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
- 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
- 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
- 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
- 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 no.1.
- Effects on reproduction:
- Effect on embryo development : see table1
- Results with reference substance (positive control):
- No reference substance
- Further details on results:
- No other details
- 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. - Validity criteria fulfilled:
- not applicable
- Conclusions:
- The application of paraffin mixture on the shell of Mallard duck egg has no effect on embryo development.
- Executive summary:
Paraffin mixture constitued of pentdecane, hexadecane, heptadecane, octadecane, nonadecane, 2,2,4,6,6-pentamethylheptane, 2,2,4,4,6,8,8-heptamethylnonane, 2,6,10,14-tetramethylpentadecane, and decahydronaphthalene, mixed in equal proportions, was applied on Mallard duck eggshell (5µL/egg). Embryonic survival, teratogenic potential and growth were evaluated.
No effect of oil application was noted, neither on embryo survival nor development.
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- 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 (100 per dose) were tested, which contributes to make the results statistically valid.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- reference to same study
- 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 are evaluated.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
No surrogate test material - Dose method:
- other: application onto egg shell
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and analysis of diet:
- No diet
- Test organisms (species):
- other: Gallus domesticus
- Details on test organisms:
- TEST ORGANISM
- Common name: Chicken
- Source: Commercial hatcheries: Whistling WIngs, Hanover, Ill., and Truslow Farms, Chestertown, Md.
- Age at test initiation (mean and range, SD): Eggs (48hr of development) - Limit test:
- no
- Total exposure duration (if not single dose):
- 15 d
- Post exposure observation period:
- No post-exposure period
- No. of animals per sex per dose and/or stage:
- 100 eggs per dose. For sex ratio, see results.
- 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 (48 hrs of development) and permitted to spread freely
NO. OF EGGS
- For negative control: 100
- For treated: 100
TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: 37.5°C
- Relative humidity (%): 60 - 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
- Duration (if not single dose):
- 15 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- Embryonic mortality
- Duration (if not single dose):
- 15 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
- Duration (if not single dose):
- 15 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
- Duration (if not single dose):
- 15 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
- Duration (if not single dose):
- 15 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 no.1.
- Effects on reproduction:
- Effect on embryo development : see table1
- Results with reference substance (positive control):
- No reference substance
- Further details on results:
- No other details
- 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. - Validity criteria fulfilled:
- not applicable
- Conclusions:
- The application of paraffin mixture on the shell of chicken eggs has no effect on embryo development.
- Executive summary:
Paraffin mixture constitued of pentdecane, hexadecane, heptadecane, octadecane, nonadecane, 2,2,4,6,6-pentamethylheptane, 2,2,4,4,6,8,8-heptamethylnonane, 2,6,10,14-tetramethylpentadecane, and decahydronaphthalene, mixed in equal proportions, was applied on chicken eggshell (5 µL/egg). Embryonic survival, teratogenic potential and growth were evaluated.
No effect of oil application was noted, neither on embryo survival nor development.
Referenceopen allclose all
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 |
Table 1. Mean liver and testes weights (± SE) in groups of 12 ducks fed paraffinic petroleum hydrocarbons for 7 months
Treatment |
Liver |
Testes |
||
Total (g) |
g/kg body weight |
Total (g) |
g/kg body weight |
|
Control |
23.8 ± 1.9 |
17.5 ± 1.4 |
14.7 ± 2.1 |
11.0 ± 1.5 |
Paraffin |
25.4 ± 1.8 |
18.9 ± 1.2 |
20.4 ± 3.3 |
15.7 ± 3.0 |
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 |
Table 1. Effects of paraffin mixture (5 µL/egg) on chicken embryos
|
Control |
Paraffin |
Number treated |
100 |
100 |
Percentage survival (Days 2 -15) |
98 |
96 |
Sex ratio, M:F |
54:46 |
50:50 |
Embryonic Weight (g) |
||
Male |
15.40 ± 1.24 |
14.85 ± 1.19 |
Female |
15.11 ± 1.18 |
15.00 ± 1.15 |
Combined |
15.25 ± 1.22 |
14.94 ±1.17 |
Crown-rump length (mm) |
||
Male |
74.4 ± 1.62 |
74.1 ± 1.55 |
Female |
73.8 ± 1.65 |
73.7 ± 2.12 |
Combined |
74.1 ± 1.63 |
73.9 ± 1.85 |
Beak length (mm) |
||
Male |
11.2 ± 0.49 |
11.0 ± 0.49 |
Female |
11.1 ± 0.36 |
10.9 ± 0.37 |
Combined |
11.2 ± 0.43 |
11.0 ± 0.42 |
Percentage that were abnormal survivors |
3.5 |
5.8 |
Description of key information
There is no data available for this substance. However, key data is available for structural analogues. The data is read across to this substance based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.
C10-C19 Paraffin mix presented a 26-week NOELR for Mallard ducks of 10000 mg/kg diet. No long-term toxicity of paraffin was observed neither to adult Mallard ducks, neither to their eggs.
C10-C19 Paraffin mix presented a 7-month NOELR for Mallard duck of 100000 mg/kg diet.
Paraffin mix (constitued of pentdecane, hexadecane, heptadecane, octadecane, nonadecane, 2,2,4,6,6-pentamethylheptane, 2,2,4,4,6,8,8-heptamethylnonane, 2,6,10,14-tetramethylpentadecane, and decahydronaphthalene, mixed in equal proportions) presented a 18-d NOELR for Mallard duck eggs of 5 µL/egg. The application of paraffin mixture on the shell of Mallard duck egg had no effect on embryo development.
Paraffin mix (constitued of pentdecane, hexadecane, heptadecane, octadecane, nonadecane, 2,2,4,6,6-pentamethylheptane, 2,2,4,4,6,8,8-heptamethylnonane, 2,6,10,14-tetramethylpentadecane, and decahydronaphthalene, mixed in equal proportions) presented a 15-d NOELR for chicken eggs of 5 µL/egg. The application of paraffin mixture on the shell of chicken eggs had no effect on embryo development.
Key value for chemical safety assessment
Additional information
Several studies investigate the effects of a mixture containing equal concentrations of C13, C15, C16, C17, C18, C19 n-paraffins, C12, C16, C19 isoparaffins and C10 cycloparaffin on mallard duck and chicken. In a first study (Hoffman, 1978), the mixture was applied directly on the egg shell (5 µL in one application) of mallard duck and chicken for 18 and 15 days respectively: the mixture had no effect on embryo development, or on sex ratio. Dietary studies with mallard ducks fed a diet containing 1% (i.e. 10 g/Kg diet) of the same paraffin mixture showed that the paraffin mixture had no effect on body and organ weights, reproduction, histopathology, hematology and serology (Patton, and Dieter, 1980; Coon and Dieter, 1981).
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