Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.1 N NaOH
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
One group of Wistar rats, consisting of two males and two females, received a single oral dose of V194024 in 0.1 N NaOH at a dose level of 2000 mg/kg body weight (dose volume 10 ml/kg bw). Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the experimental period (day 8).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
The only clinical sign noted was the hunched posture of one of the females during the first day. By the second day, this clinical sign was no longer observed.
Body weight:
Body weight gain of the animals during the 8 day study period was considered to be normal
Gross pathology:
No macroscopical findings were observed for the females.
The forestomach of the males had an irregular surface. One of the males also had nodules in the liver (right median lobe).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality was observed in the OECD 401 test with Wistar rats for 2000 mg/kg bw. The LD50 was therefore higher than 2000 mg/kg bw.