Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Limited material and methods but detailed results available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
no details provided

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
Single oral dose
Doses:
Dose levels 200 and 2000 mg/kg bw, dose volume = 10 ml/kg bw.
No. of animals per sex per dose:
2 males and 2 females
Control animals:
no
Details on study design:
Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day they were found dead or at the end of the experimental period (day 8).

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Mortality was only observed in the 2000 mg/kg bw group with males, where one fo the two animals died after 4 hours.
Clinical signs:
At 2000 mg/kg bw, clinical signs were observed up until 2 days (males) and 7 days (females) after the treatment. Clinical signs included lethargy (male/female), hunched posture (female), piloerection (female), ventro-lateral recumbency (male) and uncoordinated movements (male/female).
No clinical sign were observed at 200 mg/kg bw.
Body weight:
Normal
Gross pathology:
Macroscopic findings were only observed for the males at 2000 mg/kg bw. The urinary bladder was enlarged and contained dark red fluid.
No findings were noted at 200 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
An acute oral toxicity test (OECD 401) with V184844 (CH02586) was carried out on Wistar rats at two doses: 200 and 2000 mg/kg bw. Both males dosed at 2000 mg/kg bw died. No mortality occurred and clinical signs were observed in both males and females dosed at 200 mg/kg bw. Based on these results it was considered that the oral LD50 value of V184844 (CH02586) for the females was exceeding 2000 mg/kg bw and was between 200 and 2000 mg/kg bw for the males.
Based on these results, CH02586 should be classified as Acute Tox. 4. according to the GHS criteria.