Registration Dossier

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

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:
1965
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

Constituent 1
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

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.

Categories Display