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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The data from read across chemical 1,2-benzisothiazol-3(2H)-one 1,1-dioxide sodium salt is considered to be just the salt coumpound of the target chemical and which have more than 87.8 % structural similarity. Thus it is expected to have the similar toxicological impact.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

204-886-1

EC Name:

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

Cas Number:

128-44-9

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

-Sex: Female

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Duration of treatment / exposure:

14 days

Observation period:

The site of application was observed for skin reaction if any. The intact skin site of application of each animal was observed for signs of erythema and oedema and the responses were scored following Draize’s method at 60 min., 24, 48 and 72 hours after application.

Number of animals:

3

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Not irritating

Other effects:

Skin reaction
The test compound Sodium saccharin applied at the dose level of 0.5 gm on shaven back skin of rabbit did not produced any irritation to skin during period of observation.

Clinical Signs
The test compound Sodium saccharin applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity throughout the examination period of 14 days.

Any other information on results incl. tables

INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES

 

Rabbit No.	Sex	INTACT SKIN
		3 Min.		4 Hours		24 Hours		48 Hours		72 Hours		14 days
		Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
01	F	0	0	0	0	0	0	0	0	0	0	0	0
02	F	-	-	0	0	0	0	0	0	0	0	0	0
03	F	-	-	0	0	0	0	0	0	0	0	0	0
Total		0	0	0	0	0	0	0	0	0	0	0	0
Mean		0	0	0	0	0	0	0	0	0	0	0	0
Grand Total		0.00

 

Dermal Irritation Index: 0.0/4 = 0.0

CLINICAL SIGNS

 

SEX	ANIMAL NO.	Time (Min.)	Time (Hours)					Time (Day)
		3	1	4	24	48	72	14
FEMALE	01	N	N	N	N	N	N	N
	02	N	N	N	N	N	N	N
	03	N	N	N	N	N	N	N

 

N: No Clinical Signs

C: Clinical Signs Observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The result obtained from present experimentation reveals that the test compound 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (Sodium saccharin) in the dermal irritation study is non irritant to the skin of New Zealand white rabbits when applied to the shaven back intact skin.

Finally, it is concluded from the dermal irritation study 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (Sodium saccharin) can be classified under non irritant tested at dose level of 0.5 gm in New Zealand white rabbits.

Executive summary:

The result obtained from present experimentation reveals that the test compound 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (Sodium saccharin) in the dermal irritation study is non irritant to the skin of New Zealand white rabbits when applied to the shaven back intact skin.

Finally, it is concluded from the dermal irritation study 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (Sodium saccharin) can be classified under non irritant tested at dose level of 0.5 gm in New Zealand white rabbits.