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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Literature data

Data source

Reference
Reference Type:
publication
Title:
Effects of sulphate in water on swine reproduction and young pig performance.
Author:
Paterson D.W., Wahlstrom R.C., Libal G.W.and Olson O.E.
Year:
1979
Bibliographic source:
Journal of animal science, Vol. 49, No. 3 (1979)

Materials and methods

Principles of method if other than guideline:
Experiment was conducted to investigate the effects of high sulfate waters given to swine during gestation and lactation and to their offspring when weaned at 28 days.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium sulphate
EC Number:
231-820-9
EC Name:
Sodium sulphate
Cas Number:
7757-82-6
Molecular formula:
H2O4S.2Na
IUPAC Name:
disodium sulfate

Test animals

Species:
pig
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Animals: the reproductive trial involved 31 sows and 27 gilts.
- Source: Hampshire, Yorkshire, Duroc breeding.
- Group: sows and gilts were grouped separately on the basis of ancestry and weight.Outcome groups were randomly assigned to the three treatments.
- Housing: during gestation, all animals were housed in uninsulfated, wooden, colony type houses located in dry lots.
- Diet: feed was restricted to 1.8 kg per head daily and fed in individual feeding stalls. Fortified corn-soybean meal diets with 10% alfalfa meals (gestation) and 10% beet pulp (lactation) included 0.5% trace mineralized salt. Calculated crude protein content was 12.65 and 15.70% for gestation and lactation diets, respectively.
- Water: ad libitum available from 227 liter circular tank waterers. Self-feeders containing the lactation diet and the 227-liter waterers were located in concrete lots outside the farrowing house.
- Fedding during the test: sows were allowed access to this lot for feed and water each morning and evening for 2.0 and 1.5 hr, respectively.

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on exposure:
SALINE WATER AVAILABILITY
Saline water was available in the creep area for pigs after 10 days of age.

PREPARATION OF DOSING SOLUTIONS:
A 10% solution of the salt (analytical grade) was added as appropriate to give the desired concentrations.
Sulfate content was determined weekly by a turbidimetric method.

CONCENTRATION
- Sulphate: the averages with their standard deviations for the entire experimental period: control, 320 ± 24 ppm; low sulfate, 1790 ± 35 ppm and high sulfate, 3298 ± 139 ppm.

CONTROL
The local water supply was used as a control and for making up the experimental waters.
Duration of treatment / exposure:
30 days postbreeding, through 28 days lactation.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
620, 2840, 5060
Basis:
other: Total dissolved solids
Remarks:
Doses / Concentrations:
320, 1820, 3320 ppm
Basis:
other: Sulphate
Remarks:
Doses / Concentrations:
20, 740, 1460
Basis:
other: Sodium

Examinations

Parental animals: Observations and examinations:
Fecal condition was scored on a one to five basis, with one being most firm. Data were analyzed by least squares analysis of variance.
Litter observations:
The number of live and stillborn pigs as well as litter weight and average pig weight were obtained.
Litter weight at 14 days, number of pigs at 28 days, litter weight and average pig weight at 28 days were recorded.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
ca. 3 320 ppm
Based on:
test mat.
Sex:
female
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
ca. 3 320 ppm
Based on:
test mat.
Sex:
not specified
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Sulfate content of water consumed during gestation had no significant effect on gestation gain, number of pigs per litter at birth (total and live) or average pig and litter birth weights.

Lactation gain, number of pigs at 28 days and average pig and litter weights at 28 days were not significantly affected by sulfates in water during lactation.

Slightly less saline water was consumed during gestation. However, in lactation, water consumption increased as total dissolved solids increased.

Gilts consumed more water than sows during gestation, but slightly less during lactation.

Significant differences existed in gestation and lactation gain between gilts and sows. Gilts gained more during gestation and also gained an average of 5.5 kg during lactation, while sows lost an average of 7.0 kg during this time. The general condition and performance of the pigs during the 28-day nursing period were similar among groups. No excessive scouring was noted in any of the treatments.

 Add sulphate (ppm)
Parameter 0 1500 3000 Gilts Sows 
No. of litter 12 13 14 14 23
Average gestation gain, kg* 30.2 27.5 26.0 41.0 18.6
Average lactation gain, kg** 1.5 -5.5 1.7 5.5 -7.0
Water consumprion, L/day           
Gestation 13.3 11.2 10.6 15.1 9.2
Lactation 13.6 14.2.1 6.8 16.8 14.4 15.5
Pig/Litter             
Total 11.1 10.9 10.0 9.8 11.7
Live  9.6 10.0 8.2 8.7 9.9
Average pig birth weight, kg ** 1.4 1.4 1.5 1.3 1.5
Average litter birth weight, kg 13.5  13.5 11.8 11.6 14.2 
No pigs at 28 days 6.7 6.9 6.3 6.5 6.8
28-day pig weight, kg 6.1 6.2 6.3 6.1 6.4
28 -day litter weight, kg 40.4 42.2  40.2 39.5 42.3

*significant difference (P < 0.01) between gilts and sows.

**significant difference (P < 0.05) between gilts and sows.

Although saline water consumption of sows also increased during lactation, there was no evidence of scouring in either sows or their

nursing pigs. This study did not allow one to determine the amount of total dissolved solids in water necessary to cause problems in reproducing swine.

Applicant's summary and conclusion

Conclusions:
Sulfates up to and including 3320 ppm in water have no significant effect on reproduction in the gilt or sow. Taking into account that the highest dose of sodium sulphate in water is 4780 mg/L, that a pig can weight minimum 100 Kg and drinks about 20 L/day, the received dose without an effect is set to 956 mg/Kg bw
Executive summary:

Thirty-one sows and 27 gilts were each allotted to three treatments to study the effect of water quality during gestation and lactation. Sodium sulfate was added to the water to give sulfate and total dissolved solids in ppm as follows:

Control: 320, 620 ppm

Low sulphate: 1820, 2840 ppm

High sulphate: 3320, 5060 ppm.

Water was offered ad libitum from about 30 days postbreeding through 28 days lactation.

Result

There were no significant differences in gestation or lactation gains and number or weight of pigs at birth or at weaning. Fecal consistency was normal in all treatments. Water consumption did not differ during gestation but increased during lactation as salt level increased. These results suggest that sulfates up to and including 3320 ppm in water have no significant effect on reproduction in the gilt or sow.