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Administrative data

Description of key information

The oral LD50 for the test substance was greater than 5000 mg/kg for female rats.

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
Study period:
Single dose - 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
GLP compliance:
yes
Test type:
up-and-down procedure
Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Control animals:
no
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
A single dose of test substance was administered by oral gavage to 1 fasted female rat each at a dose of 175, 550, or 1750 mg/kg and to 3 fasted female rats at a dose of 5000 mg/kg. The rats were dosed 1 at a time at a minimum of 48 hour intervals. The rats were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. All rats were necropsied to detect grossly observable evidence of organ or tissue damage. No deaths occurred. One of the rats dosed at 5000 mg/kg exhibited high posture on the day of dosing. No other clinical signs were observed. The rats exhibited no body weight losses after dosing. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the oral LD50 for the test substance was greater than 5000 mg/kg for female rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50

Additional information

Justification for classification or non-classification