N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 September, 2003 - 18 September, 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

451-060-3

EC Name:

-

Cas Number:

122886-55-9

Molecular formula:

C31H48N4O2

IUPAC Name:

3-octyl-1-[4-({4-[(octylcarbamoyl)amino]phenyl}methyl)phenyl]urea

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): KY-UN
- Stability under test conditions: not stated
- Storage condition of test material: at room temperature and protected from light

Test animals

Species:

rat

Strain:

other: Sprague-Dawley Rj: SD (lOPS Han)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: Young adult animals (approx. 8 weeks old)
- Weight at study initiation: males: 274 ± 3 g; females: 214 ± 4 g
- Fasting period before study: overnight of approximately 18 hours before dosing
- Housing: Group housing of 3 animals of the same sex per cage in polycarbonate cages with stainless steel lid
- Diet: Free access to A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water: Free access to drinking water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% aqueous suspension of methylcellulose in purified water

Details on oral exposure:

GAVAGE METHOD: metal gavage tube fitted to a 5 mL glass syringe.

Frequency: single dosage, on Day 1.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight.

DOSAGE PREPARATION: On the day of treatment, the test item was ground to a fine powder using a mortar and pestle, and was prepared at the chosen concentration in the vehicle. The test item preparation was made freshly on the morning of administration and any unused material was discarded that same day.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day.
Body weights: The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to that of CIT control animals with the same initial body weight.
- Necropsy of survivors performed: All study animals were subjected to a macroscopic examination as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

According to Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

In an acute oral toxicity study with KY-UN with male and female rats, performed according to OECD 423 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined.

Executive summary:

KY-UN was tested in an acute oral toxicity study with male and female rats, performed according to OECD 423 test guideline and GLP principles. No deaths occurred and no clinical signs were observed. Macroscopic examination of the main organs of the animals revealed no apparent abnormalities. The overall body weight gain of the other animals was not affected by treatment with the test item. Based on the results an LD50 >2000 mg/kg bw was determined and KY-UN does not have to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.