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Diss Factsheets

Administrative data

Endpoint:
toxicity to reproduction
Type of information:
other: review
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Review by a recognised source.

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2001
Title:
Unnamed
Year:
1996

Materials and methods

Principles of method if other than guideline:
NTP standards.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium bromate
EC Number:
232-160-4
EC Name:
Sodium bromate
Cas Number:
7789-38-0
Molecular formula:
BrHO3.Na
IUPAC Name:
sodium bromate

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
7.7 mg/kg bw/day (nominal)
Based on:
other: bromate (BrO3-)
Sex:
male/female
Remarks on result:
other: Generation: P + F1

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Treated males in the 250-ppm dose group demonstrated a statistically significant decrease (18%) in epididymal sperm density. All other endpoints evaluated were comparable between controls and treated groups.

Female reproductive function was not adversely affected. There were no treatment-related gross or microscopic changes in the kidney, liver, spleen, testis, or epididymis.

These results indicated that sodium bromate treatment did not produce any adverse signs of general toxicity in any of the dose levels tested; a MTD was not reached.

On the basis of changes in sperm density, this study identifies a NOAEL of 80 ppm (7.7 mg BrO3-/kg-day) and a LOAEL of 250 ppm (22 mg BrO3-/kg-day).

Applicant's summary and conclusion

Conclusions:
A NOAEL of 7.7 mg BrO3-/kg-day was obtained in this reproductive toxicity study.
Executive summary:

A one generation reproductive toxicity study with rats was performed under NTP-standards. A NOAEL of 7.7 mg BrO3-/kg-day was obtained.