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

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test System
1.     Test Species                           : New Zealand white rabbit
2.     Age                                           : 10 to 12 weeks
3.     Sex                                           : Female
4.     Body weight range                : 1.60kg ±200g
5.     No. of animals                        : Three
6.     Acclimatization                       : The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Duration of treatment / exposure:

Irrigation:
The eyes of the test animal did not washed for at least 24 hours following instillation of the test compound. At 24 hours a washout may be used if considered appropriate.
Dose level:
A dose of 0.1gm of test substance was applied into the one eye of the rabbits. The other eye, which remains untreated, serves as a control.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after test substance application. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein. Individual animal weight before and during the study was also observed

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible

Other effects:

Irritation Scoring
The test compound Sodium saccharin when applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produced any lesions such as pannus, staining throughout the observation period of 72 hours. However some blood vessels of conjunctiva were observed hyperemic at 1 to 24th hour after the application of test substance.
Clinical Signs
The test compound Sodium saccharin applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.

Any other information on results incl. tables

GRADING OF OCULAR LESIONS

 

S.NO	SEX	OBSERVATION	Score				Total score
1	F		1 hour	24hours	48 hours	72 hours
		Cornea	0	0	0	0	0
		Iris	0	0	0	0	0
		Conjunctivae	1	0	0	0	1
		Chemosis	0	0	0	0	0
2	F	Cornea	0	0	0	0	0
		Iris	0	0	0	0	0
		Conjunctivae	1	0	0	0	1
		Chemosis	0	0	0	0	0
3.	F	Cornea	0	0	0	0	0
		Iris	0	0	0	0	0
		Conjunctivae	1	0	0	0	1
		Chemosis	0	0	0	0	0
Grand total							3
Total mean							1

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 current Acute Eye Irritation study concludes that the test compound 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (Sodium saccharin) in the amount of 0.1gm is practically non irritant to the eyes of New Zealand white rabbit when applied at the dose level of 0.1 gm.

Executive summary:

The result obtained from current Acute Eye Irritation study concludes that the test compound 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (Sodium saccharin) in the amount of 0.1gm is practically non irritant to the eyes of New Zealand white rabbit when applied at the dose level of 0.1 gm.