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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
Reason / purpose:
reference to other assay used for intermediate effect derivation
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
no guideline followed
Principles of method if other than guideline:
7-day range finding study
GLP compliance:
no
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
7 days
Frequency of treatment:
daily
Dose / conc.:
50 mg/kg bw/day (actual dose received)
Dose / conc.:
250 mg/kg bw/day (actual dose received)
Dose / conc.:
1 250 mg/kg bw/day (actual dose received)
Dose / conc.:
2 500 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
4
Control animals:
yes, concurrent vehicle
Details on study design:
Post-exposure period: none
Observations and examinations performed and frequency:
Clinical signs and mortality were checked twice daily.  Food comsumption and body weight were recorded twice a week. 
Sacrifice and pathology:
A complete macroscopic examination was performed on all animals killed at  the end of the study. Adrenals, heart, kidneys, liver, spleen, thymus and  gonades were weighed on all animals.
Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Ptyalism was observed in all the males given 1250 or 2500 mg/kg/day and in 2/4 or 3/4 females given 1250 or 2500 mg/kg/day, respectively.
Mortality:
no mortality observed
Description (incidence):
No mortality occured during the treatment period.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
A slightly lower mean food consumption and body weight gain was observed in the males given 2500 mg/kg/d.
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
During the treatment period, a slightly lower mean food consumption was observed in the males given 2500 mg/kg/day when compared to that of respective controls.
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
No effect of treatment was observed on organ weights.
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Thickened and/or translucent wall of forestomach was noted for 3/4 females given 2500 mg/kg/day.
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Key result
Dose descriptor:
NOAEL
Effect level:
1 250 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
Critical effects observed:
no
Executive summary:

In a non-guideline dose range-finding toxicity study, male and female Sprague-Dawley rats (4/sex/dose were administered 0, 50, 250, 1250, or 2500 mg/kg bw/day of di-t-dodecyl polysulfides by daily gavage for seven days. No mortality occurred during the treatment period. Ptyalism was observed in all males administered 1250 or 2500 mg/kg bw/day, and in 2/4 and 3/4 females administered 1250 and 2500 mg/kg bw/day, respectively. A slightly lower mean food consumption and body weight gain was observed in the males administered 2500 mg/kg/day. A thickened and/or translucent wall of the forestomach was noted for 3/4 females at 2500 mg/kg bw/day. There was no effect of treatment on organ weights.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
7-day range finding study.
GLP compliance:
no
Test type:
other: 7-day range finding study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Test compound: TPS 32
Chemical name: di-t-dodecyl polysulfide

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
50, 250, 1250, 2500 mg/kg
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
Clinical signs and mortality were checked twice daily. Food comsumption and body weight were record ed twice a week.Sacrifice and pathology
A complete macroscopic examination was performed on all animals killed at the end of the study. Adrenals, heart, kidneys, liver, spleen, thymus and gonades were weighed on all animals.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the treatment period
Clinical signs:
Ptyalism was observed in all the males given 1250 or 2500 mg/kg/day and in 2/4 or 3/4 females given 1250 or 2500 mg/kg/day, respectively
Body weight:
A slightly lower mean food consumption and body weight gain was observed in the males given 2500mg/kg/d.
Gross pathology:
Thickened and/or translucent wall of forestomach was noted for 3/4 females given 2500 mg/kg/day.
No effect of treatment was observed on organ weights.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In a non-guideline dose range-finding toxicity study, male and female Sprague-Dawley rats (4/sex/dose were administered 0, 50, 250, 1250, or 2500 mg/kg bw/day of di-t-dodecyl polysulfides by daily gavage for seven days. No mortality occurred during the treatment period. Ptyalism was observed in all males administered 1250 or 2500 mg/kg bw/day, and in 2/4 and 3/4 females administered 1250 and 2500 mg/kg bw/day, respectively. A slightly lower mean food consumption and body weight gain was observed in the males administered 2500 mg/kg/day. A thickened and/or translucent wall of the forestomach was noted for 3/4 females at 2500 mg/kg bw/day. There was no effect of treatment on organ weights.