Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Basic Blue 99
Author:
American College of Toxicology
Year:
2007
Bibliographic source:
International Journal of Toxicology, 26(Suppl. 2):51–63, 2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
The effects of basic blue were investigated on CF1 female mice in 90 day oral toxicity study.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Basic blue 99- Molecular formula (if other than submission substance): C19-H20-Br-N4-O2.Cl- Molecular weight (if other than submission substance): 451.75 g/mol- Substance type:Organic- Physical state:Solid- Impurities (identity and concentrations):-Purity-63%

Test animals

Species:
mouse
Strain:
CF-1
Sex:
female
Details on test animals and environmental conditions:
- Weight at study initiation: average 21 g

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Duration of treatment / exposure:
90days
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:125, 250, and 500 mg/kgBasis:no data
No. of animals per sex per dose:
Ten female mice per group
Control animals:
yes
Details on study design:
Twenty control mice received only diet.

Examinations

Observations and examinations performed and frequency:
BODY WEIGHT: YesHAEMATOLOGY: YesCLINICAL CHEMISTRY: YesURINALYSIS: YesNEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
GROSS PATHOLOGY: YesHISTOPATHOLOGY: No details available
Other examinations:
Histologically , histiocytic cell infiltration, presence offat, and hemosiderosis were found in the liver of the dosed animals, but not in control animals. Hemosiderosis in the spleens of the treated animals was comparable to the control animals. The findings were not considered dose related.
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
All mice survived the duration of the study.
Mortality:
mortality observed, treatment-related
Description (incidence):
All mice survived the duration of the study.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Mean body weights were lower than control at the end of the study.
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
effects observed, treatment-related
Urinalysis findings:
effects observed, treatment-related
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Discoloration of stomach and intestines were observed grossly.
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
effects observed, treatment-related

Effect levels

Dose descriptor:
NOEL
Effect level:
500 mg/kg diet
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Histological and behavioral changes. Also the body weight gain Is not found to be related to doses

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
None of the Basic Blue 99 doses tested led to cumulative toxic effects. NOEL was found to be 500mg/kg
Executive summary:

The effects of basic blue were investigated on CF1 female mice in 90 day oral toxicity study.10 female mice were administered basic blue 99 in diets at concentrations of 125, 250 and 500mg/kg. All the parameters including biochemistry, urinanalysis, hematology and behavioral patterns were examined. No differences in behavior or organ weight were found between dosed and control mice. No findings were considered to be dose related. Hence 500mg/kg can be concluded as a NOEL .