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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
Study period:
From 21 May to 30 July 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: The methods described by Hagan served as a guide.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch No.: not specified
Purity: not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: a suitably licensed dealer
- Age at study initiation: approximately 6 to 9 weeks
- Weight at study initiation: 200 to 300g
- Fasting period before study: approximately 18 hours
- Housing: housed in galvanized cages with indirect bedding
- Diet (e.g. ad libitum): consisted of a growth and maintenance ration from a commercial producer, ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): a 12 hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
test dose levels: 0.63, 1.00, 1.58, 2.52 and 5.00 g/kg bodyweight
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made at least once daily thereafter for a total of 14 days. Animals were weighed on the first day of dosing and at the end of the 14 day.
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacology activity, drug toxicity.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 050 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 240 - <= 3 380
Mortality:
The mortality of different dose leval as follows:
For dose level of 0.63g/kg, the mortality is 10%
For dose level of 1 g/kg, the mortality is 30%.
For dose level of 1.58g/kg , the mortality is 30%.
For dose level of 2.52 g/kg, the mortality is 10%
For dose level of 5.00g/kg, the mortality is 90%.
Clinical signs:
No information provided.
Body weight:
No change observed.
Gross pathology:
For dose level of 0.63g/kg, one animal have gastric mucosa moderately reddened.
For dose level of 1 g/kg, one animal have abscess on mesentery in lower abdominal cavity, one animal have intestinal mucosa moderately reddened, lesions on superior, middle, and inferior lobes of right lung, one animal have abscess on left lung, and one animal have gastrointestinal mucosa slightly reddened.
For dose level of 1.58 g/kg, one animal have intestinal mucosa moderately reddened, one animal have gastric mucosa moderately reddened. one animal have dorsal surfaces of median, left, and caudate lobes of liver blanched, gastrointestinal mucosa severely reddened.
For dose level of 5.00 g/kg , six animals have all lobes of liver mottled and blanched, among which four animals also have the ventral aspect of left kindey blanched, one animal have forestomach moderatley reddened, one animal have forestomach severely reddened.
Other findings:
No information provided.

Any other information on results incl. tables

Dose Level

(g/kg)

Sex

No. Dead/No. Dosed

(M:F)

Mortality

(%)

0.63

5M:5F

0/5:1/5

10

1.00

5M:5F

0/5:3/5

30

1.58

5M:5F

2/5:1/5

30

2.52

5M:5F

0/5:1/5

10

5.00

5M:5F

4/5:5/5

90

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral study in rats showed that the LD50 was 2.05 g/kg bodyweight.