Registration Dossier
Registration Dossier
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EC number: 232-160-4 | CAS number: 7789-38-0
Toxicity to reproduction
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:
- 2 001
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
- Principles of method if other than guideline:
- NTP standards.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- 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
Constituent 1
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.
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