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Description of key information

Oral LD50 (female) > 15000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
Species:
rat
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 90 - 130 g
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.
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.
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw

Additional information

The results of an old experiment are availabla on the oral acute toxicity of Fluorescent Brightener 376. 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.

Unfortunately, the testing method and procedures are not detailed and there are no details about test results.

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).