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Diss Factsheets

Administrative data

Description of key information

No adverse effects observed after repeated administration.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Rather old study without sufficient information; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form
Principles of method if other than guideline:
Internal Guideline Hoechst AG
GLP compliance:
no
Limit test:
yes
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
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
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
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
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
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
Critical effects observed:
not specified
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A 21-day study with 14 applications of Reactive Black 5 was performed with a single dose of 500 mg/kg bw/day was performed without revealing any adverse effects. The only effects seen were substance stained urine and faeces.

The subacute oral toxicity study (28 applications within 29 days) with the structural analogue 01 produced the following effects; faeces of animals of the 1000 mg/kg test group were red discoloured, beginning with day 6. Urine was red-brown discoloured in all animals of the 1000 mg/kg test group. Necropsy revealed red discoloration of the kidneys in all animals of the 1000 mg/kg test group. Additionally, the testes of the male animals were red discoloured. Vacuolization of the epithelial cells of the renal cortex was microscopically observed in two female animals of this test group, which are considered to be a result of an increased reabsorption and subsequent deposition of the test compound. Summarising, the 29-day oral administration of the substance at a dose of 1000 mg/kg body weight/day resulted in two female animals in microscopic renal findings as described above. There was no evidence in clinical chemistry and histopathology of an adverse effect on the renal function. The administration of the test compound in a dose of 1000 mg/kg body weight/day did not induce any evident relevant compound-related changes in male animals. The NOAEL was therefore considered to be 1000 mg/kg bw/day in male and female rats. With regard to the present study the No Observed Effect Level (NOEL) is 1000 mg/kg body weight/day for male and 250 mg/kg body weight day for female animals due to dye re-absorption in two females. There was no clear evidence of a toxic effect in female animals even after administration of 1000 mg/kg body weight/day.

Justification for classification or non-classification

Based on the findings of the repeated dose toxicity study, the test substance does meet the criteria of the Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and therefore no classification is needed.