Registration Dossier
Registration Dossier
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EC number: 282-468-8 | CAS number: 84229-70-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1965
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Rather old study without sufficient information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
- Principles of method if other than guideline:
- Internal Guideline Hoechst AG
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Reactive Black 5
- IUPAC Name:
- Reactive Black 5
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Preparation of Reactive Black 5: Remazol Schwarz B
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: mixed racial albino rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 90 to 124 g
- Fasting period before study: none
- Housing: group-housing: 5 rats per sex and cage
- Diet (e.g. ad libitum): Standard Altromin (Altrogge)
- Water (e.g. ad libitum): tap water
- Acclimation period: NA
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
5% solution in water
VEHICLE
- Justification for use and choice of vehicle (if other than water): -
- Concentration in vehicle: 5% (50 mg/mL)
- Amount of vehicle (if gavage): 10 mL/kg - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- -
- Duration of treatment / exposure:
- 14 treatments within 21 days (5 days/week)
- Frequency of treatment:
- 14-times on weekdays
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500 mg/kg bw/day
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
50 mg/mL
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- other: comparison to pre-treatment data
- Details on study design:
- Post-exposure period: 3 days
- Positive control:
- NA
Examinations
- Observations and examinations performed and frequency:
- Body weight: weekly
Clinical signs: daily
Urine: appearence, color, protein, sediment in 5 rats/sex beginning and end of study
Hematology: hemoglobin, erythrocyte count, leukocyte count, differential blood cell count in 5 rats/sex beginning and end of study - Sacrifice and pathology:
- Sacrifice: cervical dislocation and exsanguination
Necropsy: macroscopic evaluation
organ weights: heart, lung, liver, kidney, spleen
microscopic examination: heart, lung, liver, kidney, adrenal, spleen - Other examinations:
- behavior
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- urine and feces stained by test article
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: urine and feces stained by test article
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse effects were observed at 500 mg/kg/day.
NOEL: 500 mg/kg/day in male and female rats - Executive summary:
10 mixed race albino rats per sex received 500 mg/kg bw Remazolschwarz B 14-times in 21 days orally by gavage, followed by a 3-day post-observation time. There were no adverse effects observed in clinical signs, body weight development, urinalysis, hematology, marco- and microscopic evaluation. The test item was excreted via feces and urine.
The No Observed Effect Level is 500 mg/kg bw/day.
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