1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November/December 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

other: equivalent or similar to standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

EC Number:

257-913-4

EC Name:

1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Cas Number:

52434-90-9

Molecular formula:

C12H15Br6N3O3

IUPAC Name:

tris(2,3-dibromopropyl)-1,3,5-triazinane-2,4,6-trione

impurity 1

Reference substance name:

unknown impurities

IUPAC Name:

unknown impurities

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Sample code n°: 507-43

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight range: 94 g to 124 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test material was prepared as a 40% suspension in corn oil and administered by oral intubation at the maximum practical dosage volume of 40 ml/kg bodyweight.

Doses:

Preliminary range finding study: 0.1 g/kg bw; 0.4 g/kg bw; 1.0 g/kg bw; 4.0 g/kg bw; 16.0 g/kg bw.
Full scale test: 16.0 g/kg bw.

No. of animals per sex per dose:

2 females and 2 males for the preliminary range finding study;
5 females and 5 males for the full scale test.

Control animals:

yes

Remarks:

Rats treated with the vehicle alone (40 ml/kg bw) served as controls.

Details on study design:

Duration of observation period following administration: 14 days

Results and discussion

Preliminary study:

The results of the preliminary range finding test indicated that the median lethal oral dose (LD50) was greater than 16 g/kg bw.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities.

Clinical signs:

other: Signs of reaction to treatment observed shortly after dosing.

Body weight:

other body weight observations

Remarks:

Normal body weight gain.

Gross pathology:

Normal necropsy findings.

Any other information on results incl. tables

 

Table 1 - Mortality data for groups of rats dosed orally with 507.43, Preliminary range finding screening test

Dosage (g/kg)	Mortality ratio (No. of deaths/No. dosed)			Time of death after dosing (hours)
	Male	Female	Combined
0.1	0/2	0/2	0/4	-
0.4	0/2	0/2	0/4	-
1.0	0/2	0/2	0/4	-
4.0	0/2	0/2	0/4	-
16.0	0/2	0/2	0/4	-

 

Table 2 - Mortality ratio and group mean bodyweights (g) of rats dosed orally with 507.43, Full scale test

Sex	Dosage (g/kg)	Bodyweight (g) at			Mortality ratio (No. of deaths/No. dosed)	Time of death after dosing (hours)
		Dosing	1 week	2 weeks
Male	0	102	183	243	0/5	-
	16	109	180	237	0/5	-
Female	0	98	164	194	0/5	-
	16	101	190	190	0/5	-

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute median lethal oral dose (LD50) to both female and male rats of test item 507.43 was found to be greater than 16 g/kg bw.

Executive summary:

Female and male rats of the CFY strain were starved overnight before treatment with test item 507.43. 
The test material was prepared as a 40% suspension in corn oil and administered by oral intubation at the maximum practical dosage volume in the full scale test of 40 ml/Kg bodyweight. Rats treated with the vehicle alone (40ml/Kg) served as controls. 
During the observation period of 14 days, a record was kept of all signs of toxicity. All rats were sacrificed terminally and examined macroscopically in an attempt to identify any target organs.

The results of the preliminary range finding test indicated that the median lethal oral dose (LD50) was greater than 16 g/kg bodyweight. 
Dosing was then extended to a larger group of rats (five males and five females) in order to confirm this finding. There were no mortalities.

Signs of reaction to treatment observed shortly after dosing, included lethargy and piloerection in all treated animals and control animals. These reactions were accompanied by decreased respiratory rate in eight rats at the preliminary screen levels of 0.1 g/kg bw, 0.4 g/kg bw and 1.0 g/kg bw and in all rats at 16 g/kg bw. Increased respiratory rate was observed in two rats at each screening level of 0.4 g/kg bw and 1.0 g/kg bw. Abnormal body carriage (hunched posture) was also observed in all rats at screening levels of 0.1 g/kg bw, 0.4 g/kg bw and 1.0 g/kg and in seven rats at 16 g/kg bw.
Recovery of the treated rats, as judged by external appearance and behaviour, was apparently complete within eight days post treatment. This observation was substantiated by normal bodyweight gains and normal autopsy findings.

Thus, the acute median lethal oral dose (LD50) to rats of 507.43 was found to be greater than 16 g/kg bw.