Urea, N,N''-(methylenedi-4,1-phenylene)bis[N',N'-dimethyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

unknown

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

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:

-

EC Number:

423-370-9

EC Name:

-

Cas Number:

10097-09-3

Molecular formula:

C19H24N4O2

IUPAC Name:

1-[4-({4-[(dimethylcarbamoyl)amino]phenyl}methyl)phenyl]-3,3-dimethylurea

impurity 1

Reference substance name:

unknown

IUPAC Name:

unknown

impurity 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Water

Test material form:

solid: bulk

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5000 mg MDI-Urone
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle:The vehicle was chosen due to its non-toxic characteristics.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

As none of the animals died the LD0 is >5000 mg/kg body weight.

Clinical signs:

other: Signs of toxicity related to dose levels: Lethargy, ataxia, cool body, congestion, lacrimation, dried red material around snout, anorexia, emaciation, decreased defecation and scruffy coat

Gross pathology:

Effects on organs:
No treatment-related changes.

Other findings:

no other findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of MDI-Urone was established to be > 5000 mg/kg body weight. As none of the animals died the corresponding LD0 is > 5000 mg/kg bw. Thus, MDI-Urone is practically nontoxic.

Executive summary:

In an acute oral toxicity study according to OECD 423, groups of 3 male and 3 female rats were given a single oral dose of 5000 mg/kg body weight MDI-Urone and were observed for 14 days.

Considering the reported data of this toxicity test it can be stated that the test item MDI-Urone has no acute toxic characteristics.

According to the results obtained the LD50 was determined to be > 5000 mg/kg bw.