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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
Reference substance name:
Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
EC Number:
229-390-2
EC Name:
Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
Cas Number:
6505-30-2
Molecular formula:
C43H48N3O6S2.Na
IUPAC Name:
hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt
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:
other: No signs
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.