Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-24 - 2008-07-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The GLP study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

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 type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqua pro iniectione
Details on oral exposure:
Immediately before application the test substance was weighed, mixed in vehicle (aqua pro iniectione) and resulting suspension was administered to the stomach by tube. The single volume of administered suspension was 1ml/100 g o f animal body weight.
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 groups of 3 female animals
Control animals:
no
Details on study design:
Test procedure with a starting dose of 2000 mg/kg was selected. The test substance in this dose level was administered sequentially to two groups of 3 females (application with time distance 24 hours). No death of animals was observed therefore the testing was finished. Testing schedule (according to EUMethod B. 1 tris Annex I D)

START: 2000 mg/kg - 3 females (Step No.l): no deaths ► 2000 mg/kg - 3 females (Step No. 2): no deaths ► END of study

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
no effects
Body weight:
no effects
Gross pathology:
no effects

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the study results the value of LDgo of the test substance, Weikoform (Urea, reaction products with formaldehyde), (in female rats) is higher than 2000 mg/kg of body weight.
Executive summary:

The aim of the study was to investigate acute toxic effects of the test substance, Weikoform (Urea, reaction products with formaldehyde), after a single oral administration to Wistar rats. The testing was performed according to the Method B.l tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. The test substance was administered in a single dose as solution in vehicle {aqua pro iniectione), given orally via gavage to two groups of three female Wistar rats. The dosing was performed sequentially in two groups of three females: group No. 1 - first step and group No.2 - second step using the starting dose of 2000 mg/kg of body weight. The test substance administered at the dose of 2000 mg/kg caused no death of animals. No clinical signs of intoxication were observed in all animals. No pathologic macroscopic changes were diagnosed during pathological examination in all animals. According to the study results the value of LD50 of the test substance for female rats is higher than 2000 mg/kg of body weight.