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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
only 7 day observation period, rats were younger than recommended

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Test material Octenidine dihydrochloride
Lot/Batch number No data
Specification Win 41,462-2(b), We-Z-142
Description White powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
Age/weight at study initiation: Adult/100-130 g, Mean 116 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Viscous suspension in 1% gum tragacanth
Doses:
Concentration 500-3160 mg/kg bw
Concentration in vehicle 5-25%
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
not reported

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
800 mg/kg bw
Based on:
test mat.
Clinical signs:
Symptoms of toxicity were mainly observed among rats that died later, and included wet matted fur, dyspnea, ataxia, partial to complete absence of motor activity, and brown exudates around eyes and nares; exept for the wet matted fur, observed only on the day of medication, symptoms were not observed until the morning p.a.; loose stools were also reported on day 1 in rats given 794 or 1260 mg/kg bw; in the 2000 mg/kg bw group 1 rat appeared emaciated on day 4; 4 rats of the 1260 mg/kg bw and 1 of the 794 mg/kg bw group appeared emaciated and/or smaller than normal on day 2
Gross pathology:
In 8 of the 35 rats dying during the study the lungs were congested throughout; pitted areas and apparent thickening of the glandular portion of the stomach and adhesions of the stomach to the liver were seen in 12 of the 35 (2 at 794, 6 at 1260 and 4 at 2000 mg/kg bw); 2 of these stomachs contained black material, possibly clotted blood; in another rat that died, a large area of congestion was observed in the glandular portion of the stomach.
In those rats surviving at 7 days no gross tissue changes attributable to the drug were observed except of adhesions of stomach to the liver and spleen, and thickening, perforations, and pitted areas in the glandular portion of the stomach found in 2 rats of the 794 mg/kg bw group.
Other findings:
At 24 h, mean body weight gains of 12% and 7% had occurred in the control and 500 mg/kg bw groups, there was no change in the rats dosed with 794 mg/kg bw and there were losses of 5%, 8% and 9%, respectively, in the 1260, 2000 and 3160 mg/kg bw groups; at day 7, total body weight gains of 41%, 36% and 27%, respectively, were reported for the control, the 500 and 794 mg/kg bw groups, in the 1260, 2000 and 3160 mg/kg bw groups were no survivors

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 of octenidine dihydrochloride in rats was 800 mg/kg bw.