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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
reproductive toxicity, other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Non-GLP compliant, non-guideline experimental investigation. Study published in scientific, peer reviewed journal.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Use of recultivated electrofilter ash dumping areas for sheep breeding.
Author:
Pestevsek U, Juntes P, Pogacnik M, et al.
Year:
2000
Bibliographic source:
Bull Environ Contam Toxicol. 2000 Aug;65(2):153-60.

Materials and methods

Principles of method if other than guideline:
Pastures and hay production areas for sheep treated with electrofilter ash from coal power plants were experimentally cultivated and effects on sheep health and breeding studied.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Electrofilter ash
IUPAC Name:
Electrofilter ash
Test material form:
solid: particulate/powder
Remarks:
powder
Details on test material:
Electrofilter ash from coal power plants of Slovenia

Test animals

Species:
other: sheep
Strain:
other: Local Slovenian sheep breed
Sex:
male/female
Details on test animals or test system and environmental conditions:
Group size: 10 older ewes and 10 one year old ewes. Detailed examination of health status, hematology and clinical chemistry, and dehelminthzation were carried out prior to study.

Administration / exposure

Route of administration:
oral: feed
Details on exposure:
Exposure via grass grown on electrofilter ash treated pastures. Ash deposits were spread out in dumping areas in the depth of 2-4 meters followed by several months of watering and compression to stabilize the ground. The second phase included conveying, spreading, compression and preparation of earth deposit at the depth of 0.5 meters, seeding of grass and corresponding one year maintenance to make the pasture suitable for grazing and production of hay for winter nutrition.
Details on mating procedure:
Mating of all ewes at the end of first experimental year by the same ram.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Analysis of Pb, Cd, Cu and As, and radionuclides K40 and Cs137 in muscle, liver and kidney. Analyses carried out according to AOAC 1995 (Official methods of analysis of the AOAC, 16th edition, AOAC, Washington, D.C.
Duration of treatment / exposure:
2 years, mating at the end of the first experimental year
Frequency of treatment:
Daily via feed
Details on study schedule:
Groups of 20 ewes were maintained on pastures for one year after which two ewes from each group were euthanized for analysis. The rest of the ewes were mated and the body weight development of the offspring were monitored for 75 days. At the end of the second year three ewes from each group were euthanized and analysed. The follow-up of the remaining animals was published separately (Juntes et al., 2007).
Doses / concentrations
Remarks:
Doses / Concentrations:
Control pasture and electrofilter ash treated pasture
Basis:
other: Control pasture and electrofilter ash treated pasture
Control animals:
yes
Positive control:
no

Examinations

Parental animals: Observations and examinations:
Veterinary examination was carried out 4 times per year and included clinical examination, body weight, hematology and clinical chemistry.
Oestrous cyclicity (parental animals):
No data
Sperm parameters (parental animals):
No data
Litter observations:
Body weights at birth and at the age of 30, 45 and 75 days.
Postmortem examinations (parental animals):
Body weight , hematology, clinical chemistry, analysis of Pb, Cd, Cu and As, and radionuclides K40 and Cs137 in muscle, liver and kidney.
Postmortem examinations (offspring):
Reported separately (Juntes et al., 2007)
Statistics:
No data on methods

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Slightly higher body weight gain in the treated group. No data for food consumption.
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Slightly higher body weight gain in the treated group. No data for food consumption.
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Other effects:
no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed

Details on results (P0)

Body weight and food consumption (parental animals): Slightly higher body weight gain in the treated group due to slightly lower nutritional value of the control pastures; food consumption: no data. The nutritional value of grass was analysed four times per year and proved to be slightly but non-significantly better in the electrofilter ash treated pastures.

Test substance intake (parental animals): No differences between the treatment groups in concentrations of Pb, Cd, Cu and As, or radionuclides K40 and Cs137 in muscle, liver and kidney.

Effect levels (P0)

Dose descriptor:
other: No data
Based on:
other: analysis of Pb, Cd, Cu and As, and radionuclides K40 and Cs137 in muscle, liver and kidney
Sex:
female
Basis for effect level:
other: No data
Remarks on result:
not measured/tested
Remarks:
Effect level not specified

Results: F1 generation

General toxicity (F1)

Clinical signs:
not specified
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

No significant differences in health status, the studied parameters or the reproductive performance between experimental and control animals were found.

Applicant's summary and conclusion

Conclusions:
Maintenance of sheep on electofilter ash treated pastures had no effects on health or reproduction on sheep.
Executive summary:

In order to find out appropriate means to utilize electrofilter ash dumping areas, pastures and hay production areas for sheep were experimentally cultivated and effects on sheep health and breeding studied. Ash deposits were spread out in dumping areas in the depth of 2-4 meters followed by several months of watering and compression to stabilize the ground. The second phase included conveying, spreading, compression and preparation of earth deposit at the depth of 0.5 meters, seeding of grass and corresponding one year maintenance to make the pasture suitable for grazing and production of hay for winter nutrition. Experimental and control groups of 10 older ewes and 10 one year old ewes grazed on the pasture cultivated with electrofilter ash or ordinary pastures in the surrounding area, respectively. Health condition, body weight, hematology, clinical chemistry and reproductive performance were monitored during the study. Animals from each group were slaughtered after one or two years and hematological, clinical chemistry, gross pathological, histopathological and analytical chemistry analyses were carried out. No significant differences in health status, the studied parameters or the reproductive performance between experimental and control animals were found.

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