Registration Dossier

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:
other: Guideline study under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DA 010894 = Pyrazole DHE
Batch No GST 4-20079

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
A peroral administration was performed once using by stomach intubation using a metal gavage.
Doses:
2000mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No
Clinical signs:
no
Body weight:
Males and females body weight and body weight gain were inconspicuous in all animals.
Gross pathology:
4 males and 5 females were normal at necropsy. In the changed male large mesenteric nodes and a grey-white covering on the spleen capsule were observes. Both signs are known to occur spontaneously in the strain of rats used.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD 50 > 2000 mg/kg bw
Executive summary:

It was the aim of this study to reveal acute toxic effect of the test substance „DA 010894” Pyrazole DHE after a single peroral administration. The study was performed according to the OECD guideline 401

The Test substance “DA010894” Pyrazole DHE was dissolved in deionized water immediately before it was administered once to 5 male and 5 female Spargue Dawley rats. The dose administered was 2000 mg/kg.

Investigated was the body weight, observations during life and gross pathological examination.

Results:

Mortality: Males and females survived until 14 days p.a. till the scheduled termination

Body weight and body weight gain:

Males and females body weight and body weight gain were inconspicuous in all animals.

Observation in life:

Males and females were normal during the whole observation, except for discolored urine, noted in all animals within one day after administration. Discoloration of the urine has been found obviously caused by renally excreted test substance.

Necropsy findings: 4 males and 5 females were normal at necropsy. In the changed male large mesenteric nodes and a grey-white covering on the spleen capsule were observes. Both signs are known to occur spontaneously in the strain of rats used.

Conclusion:

No toxic effect were noted in the life and post mortem