6-(dibutylamino)-1,3,5-triazine-2,4(1H,3H)-dithione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

6-(dibutylamino)-1,3,5-triazine-2,4(1H,3H)-dithione

EC Number:

249-682-3

EC Name:

6-(dibutylamino)-1,3,5-triazine-2,4(1H,3H)-dithione

Cas Number:

29529-99-5

Molecular formula:

C11H20N4S2

IUPAC Name:

6-(dibutylamino)-1,3,5-triazine-2,4(1H,3H)-dithione

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000, 300, 50, and
5 mg/kg. Since no animal died in the first-administration group at the starting dose of 300 mg/kg, the
second-administration group received the samc dose. After confirming no animal dicd after thc second
administration, the third-administration group received the 2000-mg/k.g dose. Since no animal died
after the third administration, the fourth-administration group received the 2000-mg/kg dose again

No. of animals per sex per dose:

3

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred in any of the groups at the dose of 300 or 2000 mg/kg, and the LD50 is greater
than 2000 mg/kg.

Clinical signs:

other: (I) 300-mg/kg dose [1] First-administration group No abnormalities were noted in thc appearance or behavior. [2] Second-administration group No abnormalities were noted in the appearance or behavior. (2) 2000-mg/kg dose [1] Third-administration group One

Gross pathology:

(1) 300-mglkg dose
[1] First-administration group
Macroscopic observation revealed no abnormalities in color or configuration of the surface,
orifice, or argans or lymph nodes in the cranial, thoracic, or abdominal cavity.
[2] Second-administration group
Macroscopic observation revealed no abnormalities in color or configuration of the surface,
orifice, or argans or lymph nodes in the cranial, thoracic, or abdominal cavity.
(2) 2000-mglk:g dose
[l] Third-administration group
Macroscopic Observation revealed no abnormalities in color or configuration of the surface,
orifice, ar argans ar lymph nodes in the cranial, thoracic, ar abdominal cavity.
[2] Fourth administration (2000-mglkg dosc)
Macroscopic observation revealed no abnormalities in color or configuration of the surface,
orifice, ar argans or lymph nodes in the cranial, thoracic, ar abdominal cavity.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute toxicity of a single oral dose of Actar BSH was investigated in rats.
Twclve female SLC:Wistar rats were used in 4 groups consisting of 3.
The test substance is a white powder, and the dosing formulations were prepared with watcr for
injection as the vehicle.
As the test method, the acute toxic class mcthod was employed with doses of 2000, 300, 50, and
5 mglkg. Since no animal died in the first-administration group at thc starting dosc of 300 mg/kg, the
second-administration group received the samc dosc. After confirming no animal died after the second
administration, the third-administration group receivcd thc 2000-mglkg dose. Since no animal died
after the third administration, the fourth-administration group rcceived thc 2000-mglkg dose again. For
administration, singlc oral gavage with a metal starnach tube was selected. Observation of mortality
and general condition was performed far 14 days after administration.
As results, in the first- and second-administration groups at the dose of 300 mglk:g, no animal died,
and no abnormalities werc noted in appearance or behavior in gcncral-condition observation or necropsy. The body weights satisfactorily increased for 14 days. At 2000 mg/kg, 1 animal in the
third-administration group showed slowness in behavior followcd by abnormal gait; these signs
recovcred by after 2 hours. In the other 2 animals of the group and the ones in the
fourth-administration group, no abnormalities were noted in appearance or behavior in
gencral-condition observation. The body weights of all the animals reccived the 2000-mg/kg dose
satisfactorily increased for 14 days, and necropsy revealed no abnormalities at the dose.
Based on the abovc results, the test substance induced toxicity at the dose of 2000 mg/k:g, but not
lcthal. In conclusion, the LD50 is greater than 2000 mglkg, and it should be classifi.ed in Class5 in GHS
Classification.

Executive summary:

The acute toxicity of a single oral dose of Actor BSH was investigated in rats.

Twelve femalc SLC:Wistar rats were used in 4 groups consisting of 3.

The test substance is a white powder, and the dosing formulations were prepared with water for

injection as the vehicle.

As the test mcthod, the acute toxic class mcthod was employed with doses of 2000, 300, 50, and

5 mg/kg. Since no animal died in the first-administration group at the starting dose of 300 mg/kg, the

second-administration group received the same dose. After confirming no animal died after the second

administration, the third-administration group received the 2000-mg/k.g dose. Since no animal died

after the third administration, the fourth-administration group received the 2000-mg/kg dose again. For

administration, single oral gavage with a metal starnach tube was selected. Observation of mortality

and general condition was performed for 14 days after administration.

The results are as follows.

1. 300-mg/kg dose (the first- and second-administration groups)

No animal died, and no abnormalities in appearance or behaviors were noted in general-condition

observation. The body weights satisfactorily increascd for 14 days. Necropsy revealed no

abnormalities in any appearance ofthe surface, orifice, or argans or lymph nodes in cranial,

thoracic, or abdominal cavity.

2. 2000-mg/kg dose (the third- and fourth-administration groups)

No deaths occurred. In general condition, 1 animal ofthe third-administration group showed

slowness in behavior from 30 minutcs after administration followed by abnormal gait; these signs

recovercd by 2 hours after administration. In the other animals, no abnormalities were found in

general condition, appearance or behavior. The body weights satisfactorily increased. Necropsy

revealed no abnormalities in any ofthe surface, orifice, or argans or lymph nodes in cranial,

thoracic, or abdominal cavity.

Based on the above results, the test substance induced toxicity at the dose of 2000 mg/kg, but not

lethal. In conclusion, the LD50 is greater than 2000 mg/kg, and it should be classified in Class 5 in

GHS Classification.