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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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
Five male and five female rats received a single dose of 3.1 or 5 ml Disflamoll DPK/kg bw by gavage. The animals were observed for mortality, clinical signs, and body weight. A gross pathological examination of the surviving rats was conducted randomly.
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
Details on test animals and environmental conditions:
Animals were housed in groups of 5 animals conventional in Macrolon cages type III on dust free wood granules at a temperature of 22+/- 1.5°C. Light/dark rythmus was 12 hours. and air humidity 60 +/- 55

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5.0 ml/kg; 3.1 ml/kg bw.
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mL/kg bw
Mortality:
1 male animal died at a dose of 5 ml/kg bw.
Clinical signs:
Decreased general condition.
Body weight:
No effects.
Gross pathology:
No findings.

Any other information on results incl. tables

 Dose (ml/kg bw)  Sex  Mortality No of animals  Animals with symtoms  start of symtoms  decrease of general condition  
 5,0  male  1  5  5  after 10 hours  yes  
 5,0  female  0  5  5  after 10 hours  yes  

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In an acute oral toxicity test in 10 male and female Wistar rats the LD50 was >5000 ml/kg bw (5000 ml/kg bw = 6050 mg/kg bw; density = 1.21 mg/µg).

The decrease of general condition was the only symptom that was seen.