Registration Dossier
Registration Dossier
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EC number: 414-100-0 | CAS number: 154336-20-6 SUMIFIX BRILLIANTBLAU GL KONZENTRAT
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Adequacy of study:
- other information
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Sprague-Dawley Crj:CD(SD)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Entionisiertes Wasser
- Details on oral exposure:
- Method of administration:
Stomach tube - Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 12 animals at 0 mg/kg bw/day
Male: 6 animals at 10 mg/kg bw/day
Male: 12 animals at 100 mg/kg bw/day
Male: 12 animals at 1000 mg/kg bw/day
Female: 12 animals at 0 mg/kg bw/day
Female: 6 animals at 10 mg/kg bw/day
Female: 12 animals at 100 mg/kg bw/day
Female: 12 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
There were neither premature deaths nor substance-related deaths
Changes in behavior or in food consumption and
Weight development of the treated animals. All
treated animals had blue discolored faeces. In the high
dose group also included limbs, eyes, and perineal
Region, skin and tail sections discolored blue. This finding
proved in the tendency (eyes, skin and tail areas)
as reversible.
Laboratory findings:
There were no haematological or clinical-chemical results
toxicologically relevant changes.
Effects in organs:
At autopsy, all treated animals showed
Blue discoloration of the internal organs such as the gastrointestinal tract,
Kidneys, testes, eyeballs, thymus, pancreas and lymph nodes.
The histological examination revealed the kidneys of the animals
blue pigment build-up in the high dose group
Tubular epithelia. Similar findings were found histologically
in a weakened form at the end of the
Follow-up time. The macroscopic organ staining
had largely receded. Because of missing pathological significance
these findings were not considered to be toxicologically relevant.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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