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Description of key information

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:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
not specified
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
3 females, 3 males
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw

Two groups, each using three female or three male Hanlbm: WIST (SPF) rats, were treated with FAT 93'464/A at 4000 mg/kg by oral gavage. The test article was suspended in vehicle (polyethylene glycol PEG 300) at a concentration of 0.4 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No death occurred during the study. In all females, violet urine and dark feces were observed until test day 3. In all males, these findings were evident until test day 2. In one male, respiratory sounds were noted on test day 2. All clinical signs were reversible after 4 days. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
LD50 rat: greater than 4000 mg/kg body weight
Executive summary:

LD50 rat: greater than 4000 mg/kg body weight

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
4 000 mg/kg bw

Additional information

Justification for classification or non-classification