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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Remarks:
14-day
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline is specified in the report.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The volume of administration was 2 mL/rat.
Duration of treatment / exposure:
Animals were treated for 14 consecutive days.
Frequency of treatment:
Daily
Doses / concentrations
Dose / conc.:
2 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
10 animals per sex per group
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
MORTALITY:
- Time schedule: Daily

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily

BODY WEIGHT: Yes
- Time schedule for examinations: Twice weekly

FOOD CONSUMPTION: Yes
- Food intakes were recorded weekly

WATER CONSUMPTION: Yes
- Time schedule for examinations: Daily

HAEMATOLOGY: Yes
- Time schedule for collection of blood: Just before sacrifice
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- Blood was collected from the abdominal aorta

CLINICAL CHEMISTRY: Yes
- See above

URINALYSIS: Yes
- Time schedule for collection of urine: Urine samples were taken during the last week of treatment.
Sacrifice and pathology:
At the end of the study period all surviving rats were sacrificed and subjected to complete necropsy and histological examinations.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
Body weight gain was significantly increased (46%) in treated males, while in females body weight gain was reduced by 10% when compared to control values.
Food consumption and compound intake (if feeding study):
effects observed, non-treatment-related
Description (incidence and severity):
In males food intake was increased by 19% compared to control.
Water consumption and compound intake (if drinking water study):
effects observed, non-treatment-related
Description (incidence and severity):
Water intakes were increased by 139% and 22% in treated males and females, respectively.
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 2 000 mg/kg bw/day (actual dose received)
Sex:
male/female
Remarks on result:
not determinable due to adverse toxic effects at highest dose / concentration tested

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
Based on the results of the study, 2000 mg/kg bw of Balsalazide for 14 days did not produce any toxicity in rats (both sexes).