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Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Bi-distilled water.
Details on oral exposure:
Concentration in vehicle: 0.2 g/mL or 0.02 g/mL
Total volume applied: 10 mL/kg bw
Doses:
3 females dosed at 2000 mg/kg bw; 3 females dosed at 200 mg/kg bw; 3 males dosed at 200 mg/kg bw.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
All animals were fasted sixteen to twenty hours before dosing and three hours after dosing.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 200 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
3 f at 2000, 0 f+m at 200 mg/kg dw
Clinical signs:
In females administered 2000 mg/kg bw, ventral recumbency and marked sedation were observed in one animal during the first hour after treatment. This animal died two hours after treatment. A second animal showed slight sedation during the first two hours after treatment and moderate sedation during the second hour. The same animal showed slight and moderate ruffled fur in the second and third hours after treatment, respectively, hunched posture in the third hour after treatment, and died four hours after treatment. The third animal showed mild sedation during the first through fifth hour after treatment and ruffled fur from the second through fifth hour after treatment, and was found dead on the second day after treatment.
No clinical signs were observed in females administered 200 mg/kg bw.
In males give a dose of 200 mg/kg bw, one animal showed mild ruffled fur during the second and third hours after treatment. No other clinical signs were observed.
Body weight:
All bodyweights were within the range commonly recorded for this strain and age.
Gross pathology:
Females at 2000 mg/kg bw: Animals that died in the first and fifth hour showed distended stomach and black-brown contents of jejunum. The animal found dead on the second day showed distended stomach.
Females and males at 200 mg/kg bw: No macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 for both males and females was between 200 and 2000 mg/kg bw.
Executive summary:

The test substance was administered once by gavage to three groups of three rats each following approximately 16 to 20 hours of fasting. Dose levels were 2000 mg/kg bw and 200 mg/kg/bw to females and 200 mg/kg bw to males, all in 10 mL/kg bw. Clinical observations were made 1, 2, 3, and 5 hours after dosing and daily thereafter until termination on Day 15. Bodyweights were recorded on days 1, 8, and 15. Gross necropsies were performed on all animals.

All animals died at 2000 mg/kg bw, no mortality was observed at 200 mg/kg bw.