Dipotassium disulphate

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

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

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

13-Week Subchronic Oral Toxicity Study of Ammonium Sulfate in Rats

Author:

Takagi H, Onodera H, Yun L, Yasuhara K, Koujitani T, Mitsumori K, and Hirose M

Year:

1999

Bibliographic source:

Kokuritsu Iyuakuhin Shokuhin Eisei Kenkyusho Hokoku [Bull. Natl. Health Sci.], 117:108-114

Materials and methods

Principles of method if other than guideline:

A 13-week subchronic oral toxicity study was performed in male and female rats. Reproductive organs were examined.

GLP compliance:

not specified

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium sulphate

EC Number:

231-984-1

EC Name:

Ammonium sulphate

Cas Number:

7783-20-2

IUPAC Name:

diammonium sulfate

Details on test material:

- Purity: Not reported

Test animals

Species:

rat

Strain:

Fischer 344/DuCrj

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: ~6 weeks
- Weight at study initiation: not reported
- Fasting period before study: No
- Housing: 5per plastic cage using soft chips as bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): not reported
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24±1°C
- Humidity (%): 55±5%
- Air changes (per hr): 18
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on exposure:

See 7.5.1 DL.K2.13Wk.Diet.R.Pub.KD.ReadAcross.(NH4)2SO4 for additional details.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

13 Weeks

Frequency of treatment:

Continuously in the diet

Duration of test:

13 Weeks

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
220, 441, 886, 1792 mg/kg bw/d (males); 239, 484, 961, 1975 mg/kg bw/d (females)
Basis:
actual ingested

Doses / concentrations 2

Remarks:

Doses / Concentrations:
0.38, 0.75, 1.5, 3% in the diet
Basis:
nominal in diet

No. of animals per sex per dose:

10/sex/dose

Control animals:

yes, plain diet

Details on study design:

See 7.5.1 DL.K2.13Wk.Diet.R.Pub.KD.ReadAcross.(NH4)2SO4 for additional details.

Statistics:

See 7.5.1 DL.K2.13Wk.Diet.R.Pub.KD.ReadAcross.(NH4)2SO4 for additional details.

Results and discussion

Effect levels

Dose descriptor:

NOEC

Remarks:

reproductive organ effects

Effect level:

>= 3 other: % (equivalent to 1792 and 1975 mg/kg in males and females, respectively)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: No effects in reproductive organs were reported at the highest dose tested.

Any other information on results incl. tables

See 7.5.1 DL.K2.13Wk.Diet.R.Pub.KD.ReadAcross.(NH4)2SO4 for additional details.

Applicant's summary and conclusion

Conclusions:

In a 13-week feeding study, no effects in reproductive organs were reported.

Executive summary:

A 13-week subchronic oral toxicity study of ammonium sulphate was performed in both sexes of F344 rats by feeding them a CRF-1 powder diet containing concentrations of 0.38, 0.75, 1.5, and 3.0% of the test substance. A control group was fed plain diet. Rats were randomly divided into 5 groups each consisting of 10 males and 10 females. The mean daily doses were 220, 441, 886, 1792 mg/kg bw/day for males, and 239, 484, 961, 1975 mg/kg bw/day for females. Male animals in the 3% group exhibited diarrhoea during the administration period. No changes indicating obvious ammonium sulphate toxicity were observed in the body weights, organ weights, haematological, serum biochemical, or histopathological examinations. Based on these results, the NOEL (no-observed-effect level) of ammonium sulphate for F344 rats was judged to be 1.5% in males (886 mg/kg/day) and 3% in females (1975 mg/kg/day). No effects on reproductive organs were reported.