Perhydropyrimidin-2-one

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

other information

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:

no guideline available

Principles of method if other than guideline:

BASF-TEST: The substance was injected into the peritoneal cavity. Young adult laboratory mice were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously 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 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:

mouse

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: 28 g / females: 29 g
1600 mg/kg bw dose group: males: 28 g / females: 30 g
3200 mg/kg bw dose group: males: 27 g / females: 22 g

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

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

Details on 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 mg/kg bw dose group
- 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, 10.66 ml/kg bw of the 30% (w/v) stock solution for the 3200 mg/kg bw dose group

Doses:

200; 1600; 3200 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:

> 3 200 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

No mortality.

Clinical signs:

After injection of the TS scuttled gait, labored respiration, sunken flanks, tremor and twitching, and abdominal position. Fully reversible within 6-7 days.

Body weight:

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

Gross pathology:

Nothing abnormal detected.

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
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

Conclusions:

Under the conditions of this study the LD50 for male an female mice after i.p. application was determined to be > 3200 mg/kg bw.