Urea, reaction products with formaldehyde

Acute Toxicity: oral

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Urea, reaction products with formaldehyde

EC Number:

271-898-1

EC Name:

Urea, reaction products with formaldehyde

Cas Number:

68611-64-3

Molecular formula:

not available

IUPAC Name:

Urea, reaction products with formaldehyde

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.