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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:
20 September 1985 - 01 November 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was not performed under GLP. OECD 401 was followed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chemical name: Sodium tetra sulphide (natriumtetrasulfid)
Appearance: yellow ocher solid chrystals
Storage: room temperature

No further information. No CoA included in the study. For additional information see attached document.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG., D-4799 Borchen
- Age at study initiation: M 68 - 73 days, F 69 - 87 days
- Weight at study initiation: M 194 - 226 g, F 151 - 179 g
- Fasting period before study: 16 hours before test substance administartion food was withheld.
- Housing: 1 per cage in makrolon type II cages
- Diet (e.g. ad libitum): ad libitum standard rodent diet, sniff (R)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimal 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 20 September 1985 - 01 November 1985

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2.5-100 mg/L
- Amount of vehicle (if gavage): 2.15 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 2.15 ml/kg
Doses:
males: 100, 147, 215 mg/kg bw
females: 46.4, 100, 215 mg/kg bw
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: 6-8 hours after dosing and daily after that, time of onset clinicals signs and during was noted. Time of death and number of animals is recorded. A check for mortality is performed in twice a days before- and after-noon. In weekend once per day.
Immediateky after dosing and on days 7 and 14 bodyweights are determined, also after death.
- Necropsy of survivors performed: yes
- Other examinations performed: none
Statistics:
probitanalyse:
HUNTER, W.J., LINGK, W. and RECETT, P., Intercomparison Study on the Determination of Single Administration Toxicity in Rats, Comission of the European Commmities, Health and Safety Directorate, J. Assoc. Off. Anal. Chem 62, 864 - 873, 1979
BLISS, C.J., The Statistics of Bioassay, Academic Press, New York, 1962
FINNEY, D.J., Probit Analysis, 2nd Ed., Cambridge Univ. Press, Cambridge 1952
WEBER, E., GrundriB der biol. Statistik, F. Fischer-Verlag, Stuttgart, 7. Auflage, 1972

Results and discussion

Preliminary study:
Not applicable
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
130 mg/kg bw
95% CL:
81 - 180
Sex:
female
Dose descriptor:
LD50
Effect level:
128 mg/kg bw
95% CL:
66 - 324
Mortality:
Animals died bewteen 3-12 minutes after application. See table 1 for overview of morality.
Clinical signs:
The clinical signs observed in the animals that died were ataxia, strong klonic convulsions, reduction in muscular tone, absence of reflexes, labored breathing, difficulty breathing. The signs occur 1 minute after dosing and last until death. Animals that survived, exept for one male showing ataxia, did not show any clinical signs.
Body weight:
No effects observed.
Gross pathology:
No abnormalities observed.
Other findings:
None

Any other information on results incl. tables

Table 1 mortalities

Sex

Dose

(mg/kg)

# deaths

Total #

animals

Day 1

Day 2

Day 3

Day

4-15

 

 

 

 

a    b

a    b

a    b

a    b

 

100

1

5

1*

 

 

 

 

147

3

5

3 *

 

 

 

M

215

5

5

5 *

 

 

 

 

 

 

 

 

 

 

 

 

46.4

 

5

 

 

 

 

 

100

2

5

2 *

 

 

 

F

215

4

5

4 *

 

 

 

*Deaths occured between 3 -12 minutes.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The LD50 for males is 130 mg/kg bw (95% CI 81 -180) and for females 128 mg/kg bw (95% CI 66 -324).
Executive summary:

The acute oral toxicity of disodium tetrasulphide was investigated in an OECD 401 study using male and female rats in test groups containing 5 animals per sex per group. Doses: males: 100, 147, 215 mg/kg bw females: 46.4, 100, 215 mg/kg bw. The clinical signs observed in the animals that died were ataxia, strong klonic convulsions, reduction in muscular tone, absence of reflexes, labored breathing, difficulty breathing. The signs occur 1 minute after dosing and last until death. Animals that survived, exept for one male showing ataxia, did not show any clinical signs. Animals died bewteen 3-12 minutes after application. Autopsy revealed no abnormalities. The LD50 for males is 130 mg/kg bw (95% CI 81 -180)and for females 128 mg/kg bw (95% CI 66 -324).