1,2-benzisothiazol-3(2H)-one 1,1-dioxide

Endpoint summary

Description of key information

The substance 1,2-benzisothiazol-3(2H)-one 1,1-dioxide is not expected to show acute toxicity effect by the oral, inhalation and dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Standard acute method

GLP compliance:

not specified

Test type:

standard acute method

Species:

mouse

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

17 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Toxic effects not reported.

Mortality:

Lethal dose, 50 percent kill

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide in mouse was found to be 17000 mg/kg of body weight. Acute toxicity of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide to mouse by the oral route indicates that the substance does not exhibits acute toxicity by the oral route within the mentioned dose level.

Executive summary:

The acute oral median lethal dose (LD50) of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide in mouse was found to be 17000 mg/kg of body weight. Acute toxicity of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide to mouse by the oral route indicates that the substance does not exhibits acute toxicity by the oral route within the mentioned dose level.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

17 000 mg/kg bw

Quality of whole database:

The data is K2 level as the data has been obtained from the experimental study from the reliable journal ‘Experientia’.Based upon this available data it is expected that the test chemical 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibit acute oral toxicity to mouse within the mentioned dose level.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

(Q)SAR

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Qualifier:

according to guideline

Guideline:

other: Federal Hazards Substances Act (Revised Federal Register Sept 17 1964)

Principles of method if other than guideline:

Standard acute method

GLP compliance:

no

Test type:

standard acute method

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Type of coverage:

semiocclusive

Vehicle:

not specified

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4 694 mg/kg bw

Based on:

test mat.

Mortality:

Lethal dose ; 50 percent kill

The prediction was based on dataset comprised from the following descriptors: LD50
Estimation method: Takes average value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

("a" and ("b" and "c" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Group 14 - Carbon C AND Group 15 - Nitrogen N AND Group 16 - Oxygen O AND Group 16 - Sulfur S by Chemical elements

Domain logical expression index: "b"

Parametric boundary:The target chemical should have a value of log Kow which is >= -0.845

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.6

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide in rabbit was found to be 4694 mg/kg of body weight. Acute toxicity of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide to rabbit by dermal route indicates that 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibits acute toxicity by the dermal route within the doses mentioned in the study.

Executive summary:

The acute dermal median lethal dose (LD50) of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide in rabbit was found to be 4694 mg/kg of body weight. Acute toxicity of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide to rabbit by dermal route indicates that 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibits acute toxicity by the dermal route within the doses mentioned in the study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 694 mg/kg bw

Quality of whole database:

The data is K2 level as the data has been obtained from the QSAR model considered by OECD.Based upon this available data it is expected that the test chemical 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibit acute dermal toxicity to rabbit within the mentioned dose level.

Additional information

Acute toxicity: oral

No. of studies reviewed for acute oral toxicity from reliable sources having Klimisch rating 1 and 2.

 The summary of the results are presented below

 

Sr.No	Endpoint	Effect values	Species	CAS No.	Sources
1	LD50	17000 mg/kg bw	Mouse	81-07-2	Publication data for Target Cas
2	LD50	>2000 mg/kg	Mouse	81-07-2	Publication data for Target Cas
3	LD50	17000 mg/kg bw	Rat	Read Across 128-44-9	Publication data for Read across Cas
4	LD50	8440 - 9710 mg/kg bw	Rat	Read Across 128-44-9	Experimental data from BASF.
5	LD50	14200± 1300 mg/kg bw	Rat	Read Across 128-44-9	Publication data for Read across Cas

 

By applying weight of evidence approach to the target chemical 1,2-benzisothiazol-3(2H)-one 1,1-dioxide and the read across chemical 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (which have more than 87.8 % structural similarity), the endpoint value was found to vary between>2000 mg/kgto 17000 mg/kg bw thus it is concluded that 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibits acute toxicity by the oral route within the mentioned dose level.

Acute toxicity inhalation

The acute inhalation median lethal concentration (LC50) of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide in rat was found to be 815.265 mg/L air. Acute toxicity of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide to rat by inhalation route indicates that 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibits acute toxicity by the inhalative route within the doses mentioned in the study.

Acute toxicity dermal

The acute dermal median lethal dose (LD50) of1,2-benzisothiazol-3(2H)-one 1,1-dioxide in rabbit was found to be 4694 mg/kg of body weight. Acute toxicity of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide to rabbit by dermal route indicates that 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibits acute toxicity by the dermal route within the doses mentioned in the study.

Justification for selection of acute toxicity – oral endpoint
The acute oral median lethal dose (LD50) of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide in mouse was found to be 17000 mg/kg of body weight. Acute toxicity of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide to mouse by the oral route indicates that the substance does not exhibits acute toxicity by the oral route within the mentioned dose level.

Justification for selection of acute toxicity – inhalation endpoint
The particle size distribution of the test substance was found to vary in the size of 500 – 600 µm, so the potential for the generation of inhalable forms is low. Moreover the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore acute toxicity by inhalation route was considered to be waived.

Justification for selection of acute toxicity – dermal endpoint
The acute dermal median lethal dose (LD50) of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide in rabbit was found to be 4694 mg/kg of body weight. Acute toxicity of 1,2-benzisothiazol-3(2H)-one 1,1-dioxide to rabbit by dermal route indicates that 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibits acute toxicity by the dermal route within the doses mentioned in the study.

Justification for classification or non-classification

Based upon the study results and available information, the substance 1,2-benzisothiazol-3(2H)-one 1,1-dioxide is not expected to show acute toxicity effect by the oral, inhalation and dermal route and thus will not be considered for further classification.

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