Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is a well-conducted study that followed valid scientific prinicples.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
There is no guideline method available but the methods used in the report are deemed as appropriate for the intraperitoneal route of exposure.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test compound: TPS 37
Chemical name: di-t-nonyl polysulfide
CAS no.: 68425-16-1
Source: Elf Aquitaine
Batch: no data
Total sulfur: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: OFA
- Weight at study initiation: 140-170 g
- Housing: cage with dimensions 37.5 x 23.5 x 16 cm

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 50%
- Air changes (per hr): 6

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: none
Doses:
3500, 4500, and 6000 mg/kg
No. of animals per sex per dose:
30
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 828 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 350 - <= 4 375
Mortality:
There were deaths in all 3 dose groups. After exposure to 6000 mg/kg, there were no survivors.
Clinical signs:
One hour after treatment with 3500 mg/kg TPS 37,reduced spontaneous activity, apathy, prostration, piloerection, and slight closing of the palpebral slit was observed. Six hours after treatment, the same signs were observed. On day 2, just piloerection was observed and on day 3, piloerection was only observed in one female. All other survivors appeared normal.
 
One hour after treatment with 4500 mg/kg TPS 37, low spontaneous activity, apathy, prostration,  piloerection, and closing of the palpebral slit was observed. Six hours after treatment, moribund animals were found. Recovery of survivors began the next day.
The same observations were made when the treatment dose was 6000 mg/kg, but symptoms were more pronounced.
Body weight:
There was an increase in body weight throughout the study period.
Gross pathology:
Not performed

Any other information on results incl. tables

MORTALITY:

Dose (mg/kg)

Males

Females

3500

0/5

4/5

4500

2/5

5/5

6000

5/5

5/5



LD50: 3828 (3350-4375) mg/kg

Applicant's summary and conclusion

Conclusions:
The intraperitoneal LD50 was determined to be 3828 mg /kg bw.
Executive summary:

In an cute toxicity study Sprague-Dawley rats (5/sex/dose) were administered a single intraperitoneal dose of di-tert-nonyl polysulfide (TPS 37) at doses of 3500, 4500, or 6000mg/kg and subsequently observed for a period of 14 days.

 

Mortality was observed in male and female rats treated at all doses. One hour after treatment with 3500 mg/kg TPS 37, reduced spontaneous activity, apathy, prostration, piloerection, and slight closing of the palpebral slit was observed. These signs persisted through 6 hours and only piloerection was observed on day 2 post-exposure. On day 3, piloerection was observed in one female rat while all other surviving animals appeared normal. One hour after treatment with 4500 mg/kg TPS 37, low spontaneous activity, apathy, prostration, piloerection, and closing of the closing of the palpebral slit was observed. Six hours after treatment, moribund animals were found. Recovery of survivors began the next day. The same observations were made when the treatment dose was 6000 mg/kg, but symptoms were more pronounced. The intraperitoneal LD50 was determined to be 3828 mg/kg bw.

This study received a Kilmisch score of 2 and is classified as reliable with restrictions because it is a well-conducted study that followed valid scientific prinicples.