Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
10 male rats received a single dose of Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR in lutrol by gavage. The rats were observed during 14 days for clinical signs and mortality.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
2500 mg/kg bw.
No. of animals per sex per dose:
10 male rats/dose
Control animals:
no
Statistics:
Probit-Analysis (Fink und Hund, Arzneimittelforsch. 15, 624 (1965)

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
discriminating dose
Effect level:
2 500 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died.
Clinical signs:
No signs
Body weight:
No data
Gross pathology:
No data

Any other information on results incl. tables

Based on technical reasons, the highest applied dose was 2500 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
None of the animals died. The discriminating dose was 2500 mg/kg bw (rat, male).
Executive summary:

A single dose of 2500 mg/kg bw of the test substance was applied to 10 male Wistar rats per gavage. The animals were inspected fpor mortality and signs of intoxication during the following 14-day observation period. A dose of 2500 mg/kg body weight was tolerated without signs of poisoning by all animals. The discriminating dose was 2500 mg/kg bw.