Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Cited experiment was summarized in the US National Library of Medicine's Hazardous Substances Data Bank; original study was not reviewed
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Principles of method if other than guideline:
No data provided
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Immunotoxic effects of 2-bromopropane were investigated in male Sprague-Dawley rats. The rats were treated orally with 2-bromopropane at 100, 330 or 1000 mg/kg for 28 consecutive days. Four days before necropsy, the rats were immunized with sheep red blood cells. The body and thymus weights were significantly reduced by treatment with 2-bromopropane at the highest dose. In addition, the numbers of splenic and thymic cells were decreased by 2-bromopropane. In hematology, the numbers of white blood cells, red blood cells and platelets were significantly reduced. Among the serum clinical parameters, the levels of chloride ion were significantly increased by 2-bromopropane. The antibody response to sheep red blood cells was significantly suppressed at the highest dose. With immunized animals, immunophenotyping of splenic and thymic cells was performed to investigate the changes of the number of macrophages, B cells and T cells in the spleen and the number of CD4+ and CD8+ cells in the thymus. The numbers of most cell types were significantly decreased in the spleen when animals were treated with 2-bromopropane at 1000 mg/kg. Likewise, all cell types of thymus were significantly decreased by 2-bromopropane. The results suggest that 2-bromopropane may have an immunotoxic potential in male Sprague-Dawley rats when the rats are exposed for 28 days.

Applicant's summary and conclusion

Conclusions:
In this 28-day repeated dose key study, the 1,000 mg/kg ingested dose exposure group showed immunotoxicity to cells in male rat spleen and thymus.