1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-08-02 to 1989-01-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Version / remarks:

November 1984

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Version / remarks:

July 1987

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea

EC Number:

266-096-3

EC Name:

1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea

Cas Number:

66063-05-6

Molecular formula:

C19H21ClN2O

IUPAC Name:

1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea

Specific details on test material used for the study:

White powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 15-18 weeks.
- All animals were fasted overnight prior to dosing.
- Housing: Animals were housed individually in stainless steel cages suspended over deotized animal cage board (DACB) bedding. Bedding was changed three times weekly and rats were transferred to clean cages every three weeks.
- Diet: ad libitum
- Water: municipal, ad libitum
- Acclimation period: at least six days.
- Method of randomisation in assigning animals to test and control groups: Rats were assigned to cages from a list of computer-generated random numbers. Animals were assigned to dose groups from consecutively numbered cages.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 26°C
- Humidity: 40 to 70%
- Photoperiod: 12-hour light/dark cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

DOSE VOLUME APPLIED: 10 mL/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5/sex/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: twice daily during the week and once daily on weekends. Rats were weighed on the day of treatment and on days 7 and 14 after treatment.
- Necropsy of survivors performed: yes
All animals were subjected to a gross pathologic examination as soon as possible following their death. Survivors were sacrificed by CO2 asphyxiation on day 14 after treatment.
- Clinical signs including body weight: The weight range for all animals was within ±20% of the mean for each sex.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred at the oral limit dose (5000 mg/kg bw).

Clinical signs:

other: Urine stain

Body weight:

other body weight observations

Remarks:

Body weight increased for all animals from days 0-7 and for all but one female (8 g loss) from days 7-14.

Gross pathology:

No gross lesions were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Pencycuron does not require classification for acute oral toxicity in any CLP category on the basis of this study. For both males and females the acute oral LD50 was >5000 mg/kg bw and the no-observed-effect level was <5000 mg/kg bw.

Executive summary:

The acute oral toxicity of pencycuron was tested in young adult male and female (5/sex) Sprague-Dawley rats using the oral limit dose (5000 mg/kg bw). Pencycuron was administered by gavage in polyethylene glycol (10 mL/kg). Animals were observed for 14 days post-dosing for mortality and clinical signs. Body weights were recorded on the day of treatment (day 0) and on days 7 and 14. On day 14 the animals were sacrificed and a gross necropsy was performed.

 

No deaths were observed at the oral limit dose, therefore, LD₅₀ estimates were not determined. Treatment related clinical signs, consisting of urine stain in four animals (three males and one female) and anal stain in one male, were resolved by day 3. Body weights increased for all animals from days 0-7 and for all but one female from days 7-14. No treatment-related gross lesions were observed at necropsy. For both males and females, the oral LD₅₀ for pencycuron was >5000 mg/kg bw.