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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:
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 similar to OECD guideline 401.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Body weights are not taken daily and gross pathology and necroscopy were not completed.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

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

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:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
none
Doses:
16000, 18000, 22000, and 24000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations but weighing was only done at the start and end of the experiment
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and body weight
Statistics:
Probit, Litchfield and Wilcoxon, and Arcsin

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
19 550 mg/kg bw
Based on:
test mat.
95% CL:
>= 17 781 - <= 21 495
Mortality:
Groups administered a 22000 mg/kg dose experienced a 70% mortality rate. Groups administered a 16000 mg/kg dose experienced a 20% mortality rate. Groups administered a 18000 mg/kg dose experienced a 30% mortality rate. Groups administered a 22000 mg/kg dose experienced a 60% mortality rate. Groups administered a 24000 mg/kg dose experienced a 80% mortality rate.
Clinical signs:
Clinical signs were generally observed on the day of administration of the dose and one day following. Recovery of clinical signs was observed in most groups 3 days after exposure.
Body weight:
Body weight generally did not change from the initial weighing.
Gross pathology:
Not completed

Any other information on results incl. tables

MORTALITY:

Dose mg/kg

Male

Female

Total

16000

2/5

0/5

2/10

18000

2/5

1/5

3/10

22000

1/5

5/5

6/10

24000

4/5

4/5

8/10



Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of TPS37 was 19550 (17781-21495) mg/kg.
Executive summary:

In an acute oral toxicity study, groups of male and female Sprague-Dawley rats were given a single gavage dose of TPS 37 at doses of 16000, 18000, 22000, and 24000 mg/kg and observed for 14 days.

 

One hour after treatment with16000 and 18000 mg/kg of TPS 37, rats were observed to be experiencing spontaneous activity in lower limbs, apathy, piloerection, prostration, and slight closing of the palpebral slit. These same symptoms were observed after 6 hours to exposure. On day 3, the surviving animals appeared to be symptom free and functioning normally. After treatment with22000 and 24000 mg/kg of TPS 37, a severe reduction in spontaneous activity, prostration, and staggering step was observed. Similar signs were observed 24 hours later as well as diarrhea. On day 2, piloerection was observed in surviving animals. On day 3, test animals administered 22000 mg/kg were beginning to recover. Those administered 24000 mg/kg were observed to have a distended abdomen. The oral LD50 was determined to be 19550 mg/kg bw in males and females.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is equivalent or similar to OECD guideline 401.