1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-

EC Number:

813-543-0

Cas Number:

73984-93-7

Molecular formula:

C14H26N2S4

IUPAC Name:

1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Albino (Charles River strain)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., North Wilmington, Mass.
- Weight at study initiation: 171 to 213g (males) and 163 to 214g (females)
- Fasting period before study: yes, animals were fasted for 16 h prior to dose administration
- Housing: individually in suspended, wire-mesh cages
- Diet: standard laboratory diet ad libitum
- Water: ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Doses adminstered by oral gavage.

Doses:

4556, 6834, 10250 and 15380 mg/kg

No. of animals per sex per dose:

4 male and 4 female per dose level

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations conducted daily and body weights conducted at study initiation and study termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Weil, Carrol S.: Tables for Convenient Calculation of Median- Effective Dose (LD50 or ED50) and Instructions in Their Use, Biometrics, Sept. 1952.
Thompson, William R.: Use of Moving Averages and lnterpolaton to Estimate Median-Effective Dose. Bact. Rev., Nov. 1947.
Thompson, William R. and Weil, Carrol S.: On the Construction of Tables for Moving Average Interpolation. Biometrics, March 1952.

Results and discussion

Preliminary study:

No preliminary study performed.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

10 250 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Std. dev. 1203 mg/kg

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

6 176 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Std. dev. 627 mg/kg

Mortality:

4556 mg/kg: 0/4 males and 0/4 females
6834 mg/kg: 0/4 males and 3/4 females
10250 mg/kg: 2/4 males and 4/4 females
15380 mg/kg: 4/4 males and 4/4 females
Animals died between 6h and 3 days following dose administration.

Clinical signs:

other: 4556 mg/kg: males - hypoactivity, ruffed fur; females - hypoactivity, ruffed fur, diarrhoea, salivation, muscular weakness 6834 mg/kg: males - hypoactivity, ruffed fur, diarrhoea, salivation, muscular weakness; females - hypoactivity, ruffed fur, diarrh

Gross pathology:

No findings noted.

Other findings:

Necropsy of the animals that died during the 14 day observation period revealed enteritis.

Any other information on results incl. tables

The acute oral median lethal dose (LD50) was calculated to be 10250 mg/kg in male albino rats or 6176 mg/kg in female albino rats.

Table 1. Male body weights

Dose (mg/kg)	Animal No.	Body Weight (g)
		Day 0	Day 14
4556	1 2 3 4	210 205 189 203	316 308 298 304
6834	5 6 7 8	187 179 190 182	305 297 310 299
10250	9 10 11 12	188 177 189 191	NA 286 290 NA
15380	13 14 15 16	171 188 213 206	NA NA NA NA

           NA = Not applicable (animal died before end of 14 day observation period)

Table 2. Female body weights

Dose (mg/kg)	Animal No.	Body Weight (g)
		Day 0	Day 14
4556	1 2 3 4	163 183 182 178	217 223 227 223
6834	5 6 7 8	189 203 166 198	NA 229 NA NA
10250	9 10 11 12	205 171 214 213	NA NA NA NA
15380	13 14 15 16	178 171 164 178	NA NA NA NA

           NA = Not applicable (animal died before end of 14 day observation period)

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The test report describes a valid guideline study, without information about GLP compliance.The acute oral median lethal dose (LD50) for the test material was determined to be 10250 mg/kg in male and 6176 mg/kg in female rats. Thus, the test substance can be considered as not acutely toxic via the oral route.

Executive summary:

An acute oral study was conducted using a similar procedure to that described in the current OECD Guideline 401 (Anonymous, 1973). The test material (CAS No. 73984 -93 -7) was administered at dose levels of 4556, 6834, 10250 and 15380 mg/kg by oral gavage to four male and four female rats. The rats were observed for 14 days after test material administration. General signs of intoxication exhibited by the rats following dosing included hypoactivity, ruffed fur, diarrohea, salivation and muscular weakness. There were no mortalities in the lowest dose group (4556 mg/kg), there were no mortalities in the males and 3/4 females in the 6834 mg/kg dose group,  there were 2/4 male mortalities and 4/4 female mortalities in the 10250 mg/kg dose group and there were no surviving animals in the highest dose group, 15380 mg/kg. Necropsy of the animals that died revealed enteritis. No gross pathologic alterations were noted among the animals.

The acute oral median lethal dose (LD50) was calculated to be 10250 mg/kg in male albino rats or 6176 mg/kg in female albino rats.