Propazine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Contains sufficient detail to suggest GLP-like characteristics even though no statement of certification is reported (reasonably thorough description of authors, dates, design, results, and interpretation).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The test substance was suspended with carboxymethyl-cellulose 2%. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propazine

EC Number:

205-359-9

EC Name:

Propazine

Cas Number:

139-40-2

Molecular formula:

C9H16ClN5

IUPAC Name:

6-chloro-N2,N4-bis(propan-2-yl)-1,3,5-triazine-2,4-diamine

Details on test material:

Product designation: propazine
Batch No. Lot. 368

Test animals

Species:

rat

Strain:

other: bred rats of the Tif: RAIf (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were kept at a room temperature of 22 ± 10 °C, at a relative humidity of 55 ± 5 % anti on a 14 hours light cycle day. They received ad libitum rat food NAFAG, Gossau SG - and water. Prior, to treatment the animals were adapted to our laboratories for a minimum of 4 days and the initial body weight ranged from 160 to 180 grams
During the treatment and observation period the animals were housed ingroups of 5 in Macrolon cages (type 3)

Administration / exposure

Route of administration:

other: oral intubation

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The substance was suspended with carboxymethyl - cellulose2 %. Before treatment the suspension was homogeneously dispersed with an Ultra - Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

The following doeses have been given:
3170 mg/Kg
4640 mg/Kg
6000 mg/Kg
7750 mg/Kg
No higher doses were possible

No. of animals per sex per dose:

Per each doses 5 male and 5 female have been treated.

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 700 mg/kg bw

Mortality:

Any mortality has been occurred within the 14 days of treatment.

Clinical signs:

other: Within 2 hours after treatment the rats in dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur.The animals recovered within 9 to 10 days.

Gross pathology:

The animals were submitted to a necropsy at the end of the observation period.
No substance related gross organ changes were seen.

Any other information on results incl. tables

Rate of deaths:

Dose mg/Kg	No. of animals		Died within 1 hr.        2 hrs.           48 hrs.         7 days           14 days
	M	F	M	F	M	F	M	F	M	F	M	F
3170	5	5	0	0	0	0	0	0	0	0	0	0
4640	5	5	0	0	0	0	0	0	0	0	0	0
6000	5	5	0	0	0	0	0	0	0	0	0	0
7750	5	5	0	0	0	0	0	0	0	0	0	0

M = male

F = female

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: not specified