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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental study performed using standard test guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of test chemical was performed on Rats(Male/female)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
Test animals :Spraque-Dawley rats (male/female), SPF breed : WIGA, Sulzfeld, FR G

Body weight : 77/13 0
Mean weight for
- male animals : 298 g
- female animals : 215 g

Diet : The animals were offered Herilan MRH-Kraftfutter, supplied by H . EGGERSMANN, Rinteln/Weser, FRG, and water ad libitum . Diet withdrawn 16 hours before beginning of study .

Form of application : The product was administered once by gavage as a 50% solution in aqua dest . in doses of 5620, 6810, 8250 and 10000 mg/kg .

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
No details available

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
the product was administered once by gavage as a 50% solution in aqua dest . in doses of 5620, 6810, 8250 and 10000 mg/kg .
Doses:
5620 mg/kg
6810 mg/kg
8250 mg/kg
and 10000 mg/kg
No. of animals per sex per dose:
10 males
10 female
Control animals:
not specified
Details on study design:
Not specified

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
8 980 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no other details available
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
9 140 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no other details available
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
8 820 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no other details available
Mortality:
50% death was observed in male and female rats
Clinical signs:
Not specified
Body weight:
Not specified
Gross pathology:
Not specified
Other findings:
Not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute oral median lethal dose (LD50) of test chemical in male/female sprague-dawley rat was determined to be 8440-9710 mg/kg of body weight. LD50 value indicates that the test chemical does not exhibits acute toxicity by the oral route.
Executive summary:

The acute oral toxicity of test chemical was performed in Sprague-Dawley rats . For this purpose, the product was administered once by gavage as a 50% solution in aqua dest . in doses of 5620, 6810, 8250 and 10000 mg/kg .

The median lethal dose (LD 50) after 14 days was observed to be 8980 (8440 - 9710) mg/kg in male and female rats.In male animals LD50 value was observed to be 9140 (8350 - 10510) mg/kg whereas in female animals ,8820 (7960 - 10090) mg/kg.

From the above study it is concluded that test chemical does not exhibits acute toxicity by the oral route.