Registration Dossier
Registration Dossier
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EC number: 617-116-8 | CAS number: 80573-04-2
Repeated dose toxicity: oral
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:
- 2 000
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 substance name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Cas Number:
- 150399-21-6
- Molecular formula:
- C17H13N3O6Na2 . 2H2O
- IUPAC Name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Test material form:
- solid
Constituent 1
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).
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