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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:
1972
Report date:
1972

Materials and methods

Principles of method if other than guideline:
The experiment was conducted following the procedures outlined into the "Handbook of Toxicology" by W.S. Spektor.
GLP compliance:
no
Remarks:
pre GLP
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
Fluorescent Brightener 367
IUPAC Name:
Fluorescent Brightener 367

Test animals

Species:
rat
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 90 - 130 g

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
The product was administered as a 25 % suspension in 2 % mucilage of starch.
Doses:
15000 mg/kg bw
Details on study design:
After the application, the animals were kept under observation for another 7 days.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Clinical signs:
Animlas were normal.

Applicant's summary and conclusion

Conclusions:
LD50 (female) > 15000 mg/kg bw
Executive summary:

The experiment was conducted following the procedures outlined into the "Handbook of Toxicology" by W.S. Spektor. The product was administered as a 25 % suspension in 2 % mucilage of starch in female rats. The dose administrated was 15000 mg/kg bw. After the application, the animals were kept under observation for another 7 days. No animal died and animlas appeared normal.

Conclusion

LD50 (female) > 15000 mg/kg bw