Reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on test type (migrated information)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Sodium sulphate was tested. Limited documentation, low numbers of animals per dose group, only females were treated, no fertility indices were measured.

Data source

Reference

Reference Type:

publication

Title:

Influence of sulfate in drinking water on mouse reproduction during two parities.

Author:

Andres CJ and Cline TR

Year:

1989

Bibliographic source:

J Anim Sci 67: 1313-1317.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]

Deviations:

yes

Remarks:

Limited documentation, low numbers of animals per dose group, only females were treated, no fertility indices were measured.

Principles of method if other than guideline:

10 females were treated with sodium sulphate, the males were untreated.
Sixty random-bred ICR female virgin mice were used. Mice were assigned randomly to one of six water treatments (control, Na control, 4 dose levels of sodium sulphate). All groups contained equal levels of Na, which was maintained by varying the amount of sodium bicarbonate added. The treated water was available ad libitum beginning 1 wk prior to breeding and was continued throughout the experiment. After 1 wk of acclimation to the treatments, a male mouse that had received tap water was paired randomly with each female mouse. The females were checked every 24 hours in the morning for  the presence of a vaginal plug. After a vaginal plug was observed, the  male mouse was removed and the female was weighed. Water consumption was measured daily during the 2nd and 3rd wk of gestation, and the 1st and 2nd wk of lactation. At parturition, the dams were weighed and litter size was recorded. The litters then were standardized to eight pups per litter. At 21 days postpartum, the pups were weaned and the litters and dams were weighed individually. The dams were then rebred at first estrus immediately following weaning. This procedure was carried out over two parities. Only animals that whelped during each parity were used in the analysis. Thus, the number of dams per dose group in the first parity was 4-9, in the second parity it was only 4. Fertility indices were not  measured.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

7727-73-3

EC Number:

616-445-4

Cas Number:

7727-73-3

IUPAC Name:

7727-73-3

Constituent 2

Reference substance name:

Sodium sulphate

EC Number:

231-820-9

EC Name:

Sodium sulphate

Cas Number:

7757-82-6

Molecular formula:

O4S.2Na

IUPAC Name:

sodium sulfate

Constituent 3

Reference substance name:

disodium sulfate decahydrate

IUPAC Name:

disodium sulfate decahydrate

Details on test material:

- Name of test material (as cited in study report): Sodium sulfate; no further data

Test animals

Species:

mouse

Strain:

ICR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
random-bred virgin female ICR mice
- Housing: individually in stainless steel cages
- Diet (ad libitum): commercially prepared breeder block
- Water (ad libitum): dosing solution or control water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.6 °C
- Humidity (%): 55%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

water

Details on mating procedure:

cohabitation with untreated males
- M/F ratio per cage: 1/1
- Length of cohabitation: 24 h
- Proof of pregnancy: vaginal plug

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Exposure period: from one week prior to breeding until study end (day 21 of second parity)
Premating exposure period (males): no treatment (tap water ad lib)
Premating exposure period (females): 1 week

Frequency of treatment:

continuously in the drinking water

Details on study schedule:

no data

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
625, 1250, 2500 or 5000 mg sulphate/L
Basis:
nominal in water

Doses / concentrations 2

Remarks:

Doses / Concentrations:
ca. 250-850, 480-2040, 1270-4320, 1790-6560 mg/kg bw/d
Basis:
nominal conc.

No. of animals per sex per dose:

10 females

Control animals:

yes, concurrent vehicle

Examinations

Statistics:

Least squares mean analysis of variance (SAS, 1982).
Student's t-test was used to determine the difference in water consumption.

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

1

Dose descriptor:

NOAEL

Effect level:

1 790 - 6 590 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

female

Basis for effect level:

other: no substance-related adverse effects noted

2

Dose descriptor:

NOAEL

Effect level:

5 000 mg/L drinking water

Based on:

test mat.

Sex:

female

Basis for effect level:

other: no substance-related adverse effects noted

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

Sixty random-bred albino mice were randomly assigned to six sulphate treatments. Sodium sulphate was added to deionized distilled water to give sulphate levels in ppm as follows:

(1) 0 (control);

(2) 0 (Na control);

(3) 625;

(4) 1250;

(5) 2500 and

(6) 5000.

Treatments 2 to 6 contained the same Na content (2392 ppm) by varying Na bicarbonate content. Mice receiving only the deionized distilled water drank less (P <0.05) than mice receiving the other treatments at all times measured. Animals offered the 0 (Na control) water drank more (P < 0.05) water than mice on the other sulphate treatments. There was no difference (P> 0.10) in litter size, litter weaning weight, or gestational and lactational weight gain of the dams among water treatments. Although levels of sulphate up to 5000 ppm and 2392 ppm Na in the thinking water altered water consumption, they did not affect litter size, litter weaning weight, or gestational and lactational weight gain of the dam when sulphate ingestion was continued over two parities.

Applicant's summary and conclusion

Executive summary:

Sixty random-bred albino mice were randomly assigned to six sulphate treatments. Sodium sulphate was added to deionized distilled water to give sulfate levels in ppm as follows:

(1) 0 (control);

(2) 0 (Na control);

(3) 625;

(4) 1250;

(5) 2500 and

(6) 5000.

Treatments 2 to 6 contained the same Na content (2392 ppm) by varying Na bicarbonate content. Mice receiving only the deionized distilled water drank less (P < 0.05) than mice receiving the other treatments at all times measured. Animals offered the 0 (Na control) water drank more (P < 0.05) water than mice on the other sulphate treatments. There was no difference (P > 0.10) in litter size, litter weaning weight, or gestational and lactational weight gain of the dams among water treatments. Although levels of sulphate up to 5000 ppm and 2392 ppm Na in the thinking water altered water consumption, they did not affect litter size, litter weaning weight, or gestational and lactational weight gain of the dam when sulphate ingestion was continued over two parities.