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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From February 26th to April 24th, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Version / remarks:
1995
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
Blue REg 6080
IUPAC Name:
Blue REg 6080

Test animals

Species:
rat
Strain:
Wistar
Remarks:
HanBrl
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
Test duration: 28 days
15-day recovery for 5 animals per sex in control group and 1000 mg/kg bw/day group
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Remarks:
control
Dose / conc.:
50 mg/kg bw/day (actual dose received)
Dose / conc.:
200 mg/kg bw/day (actual dose received)
Dose / conc.:
1 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
Clinical signs, outside cage observation, food consumption and body weights were recorded periodically during pretest, treatment and recovery periods.
Urine samples were collected for urinalyses. All animals were killed, necropsied and examined post-mortem. Histological examinations were performed on organs and tissues from all control and high dose animals, and all gross lesions from all animals.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Dark feces were noted from treatment day 3 and 4 onwards in both sexes treated with 200 and 1000 mg/kg/day. This finding persisted in the high dose group for two days of the recovery period. It is not toxicologically relevant.
No changes on grip strength and locomotor activity.
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, non-treatment-related
Food consumption and compound intake (if feeding study):
no effects observed
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
A 'left shift' towards high fluorescence reticulocytes and a very slight increase in absolute and relative reticulocytes counts were noted in male (more clearly evident) and female rats treated at 1000 mg/kg.
All other hematological parameters were unaffected.
Description (incidence and severity):
No test item-related effects.
Description (incidence and severity):
No test item-related effects.
Description (incidence and severity):
No test item-related effects.
Gross pathological findings:
effects observed, non-treatment-related
Description (incidence and severity):
Spontaneous findings in rats of this strain and age.
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
Spontaneous findings in rats of this strain and age.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
clinical biochemistry
clinical signs
food consumption and compound intake
gross pathology
haematology
histopathology: non-neoplastic
mortality
organ weights and organ / body weight ratios
urinalysis
Dose descriptor:
NOEL
Effect level:
200 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
haematology

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
In male and female rats dosed for 28 days by gavage and dose of 50, 200, 1000 mg/kg and with vehicle only in acontrol group. A recovery period of 15 days was included for control and high dose group.
NOEL = 200 mg/kg bw/day
NOAEL = 1000 mg/kg bw/day