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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:
1984-06-14 to 1984-07-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: References see below
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not applicable
Principles of method if other than guideline:
Test is performed according to the following references:
- Bliss, C.J., The Statistics of Bioassay, Academic Press, New York, 1962
- Finney, D.J., Probit Analysis, 2nd Ed. Cambridge Univ. Press, Cambridge 1952
- Hunter, W.J., Link, W. and Recht, P., Intercomparison study on the determination of single administration toxicity in rats, Commission of the European Communities, Health and Safety Directorate, J. Assoc. Off. Anal. Chem. 62, 864 - 873, 1979
- Weber, E., Grundriß d. biol. Statistik, G. Fischer-Verlag, Stuttgart, 7. Auflage, 1972
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
- body weight: male 141 - 199 g; female 135 - 163 g
- age: male 57-59 days; female 63 - 72 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
not indicated
Doses:
2.15 - 10.0 mL/kg (215 - 1000 mg/kg)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
not indicated
Statistics:
NA

Results and discussion

Preliminary study:
NA
Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
681 mg/kg bw
Based on:
test mat.
95% CL:
312 - 1 487
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
582 mg/kg bw
Based on:
test mat.
95% CL:
366 - 926
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
215 mg/kg bw
Based on:
test mat.
Mortality:
At the dose of 215 mg/kg, the mortality rate was 0 % and at the dose of 1000 mg/kg, the mortality rate was 80 %.
Clinical signs:
The symptoms of poisoning were disorders of central nervous system and decrease of tonicity . Additional disorders: conical convulsions, tonic convulsions and loss of startle reflexes were showed.
Body weight:
not indicated
Gross pathology:
not indicated
Other findings:
At macroscopic examination of dead animals was showed in female rats of the medium concentration the intestinal mucosa full with a red liquid.

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50-values were 582 mg/kg bw (female, rat) and 681 mg/kg bw (male, rat).
Executive summary:

In an acute oral toxicity study, groups of fasted 57-72 days old Wistar rats (3/sex) were given a single oral dose of sodium cyanate (98 %) in water by gavage at doses of 215 to 1000 mg/kg bw.

Oral LD50

Males = 681 mg/kg bw

Females = 582 mg/kg bw

LD0 (male/female) = 215 mg/kg bw