Perhydropyrimidin-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Propyleneurea

IUPAC Name:

Propyleneurea

Details on test material:

- Name of test material (as cited in study report): Propyleneurea
- Physical state: solid
- Purity: 97%

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Mean body weight at study initiation:
200 mg/kg bw dose group: males: 197 g / females: 202 g
1600 mg/kg bw dose group: males: 193 g / females: 202 g
3200 mg/kg bw dose group: males: 232 g / females: 186 g
6400 mg/kg bw dose group: males: 226 g / females: 206 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: water (2 and 10% w/v dosing preparation) or suspension with tragacanth (30% w/v dosing preparation)

Details on oral exposure:

DOSAGE PREPARATION:
- Stock solutions prepared: 2% (w/v) for the 200 mg/kg bw dose group, 10% (w/v) for the 1600 mg/kg bw dose group, 30% (w/v) for the 3200 and 6400 mg/kg bw dose groups
- Dose volume applied: 10 ml/kg bw of the 2% (w/v) stock solution for the 200 mg/kg bw dose group, 16 ml/kg bw of the 10% (w/v) stock solution for the 1600 mg/kg bw dose group, 10.6 ml/kg bw of the 30% (w/v) stock solution for the 3200 mg/kg bw dose group, 21.3 ml/kg bw of the 30% (w/v) stock solution for the 6400 mg/kg bw dose group

Doses:

200; 1600; 3200; 6400 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- The animals were observed for mortality and clinical signs of toxicity
- Frequency of observations: Several times on the application day, thereafter once each working day
- Body weights were only recorded at the beginning of the study
- Necropsy of survivors and animals which died performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 400 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

No mortality.

Clinical signs:

Restless behavior, ruffled fur, high-legged and, in some cases, waddling gait, accelerated respiration, pronounced wiping of the snouts and compulsive chewing were observed on the day of the study. During 2 or 3 days, the behavior was quieter than normal, the animals cowered and showed accelerated respiration and slightly ruffled fur. They recovered after this time and were sacrificed and necropsied after 7 days.

Body weight:

Body weights were not recorded during and at the end of the observation period.

Gross pathology:

Chronic bronchitis and bronchiectases in four animals; no abnormalities were detected in the organs of the remaining animals.

Any other information on results incl. tables

Mortality:

Dose mg/kg	Conc. %	No. of animals	Died within
			1 h	24 h	48 h	7 d	14 d
6400	30	10	0/10	0/10	0/10	0/10	-
3200	30	10	0/10	0/10	0/10	0/10	-
1600	10	10	0/10	0/10	0/10	0/10	-
200	2	10	0/10	0/10	0/10	0/10	-

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

Under the conditions of this study the LD50 for male and female rats after oral application was determined to be > 6400 mg/kg bw.