Phthalylsulfathiazole

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phthalylsulfathiazole

EC Number:

201-627-4

EC Name:

Phthalylsulfathiazole

Cas Number:

85-73-4

Molecular formula:

C17H13N3O5S2

IUPAC Name:

2-({4-[(1,3-thiazol-2-yl)sulfamoyl]phenyl}carbamoyl)benzoic acid

Details on test material:

- Name of test material : phthalylsulfathiazole
- Molecular formula : C17H13N3O5S2
- 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:

Age : 10 to 12 weeks
Sex : Female
Body weight range : 1.80kg ±200g
No. of animals : Three
Acclimatization : The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.
Environmental conditions : Air conditioned room with 10-15 air changes per hour, temperature between 22-250C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

Test system

Vehicle:

water

Amount / concentration applied:

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

Duration of treatment / exposure:

21 days

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:

No. of animals : Three

Results and discussion

In vivo

Results

Irritation parameter:

other: MMAS(Modified Maximum Average Draizes Test Score)

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Other effects:

The test compound phthalylsulfathiazole applied in conjunctival sac of rabbits did not show any observable clinical signs such as cage side activity and pain or stress etc. throughout the observation period of 21 days.

Any other information on results incl. tables

The test compound phthalylsulfathiazole applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produce any clinical signs of eye irritation. Furthermore, any lesions such as pannus, staining were not recorded throughout the observation period

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

phthalylsulfathiazole in non irritating to eye

Executive summary:

Irritation Scoring

The test compound 85-73-4 applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm produce mild eye discharge and slight redness at 4 hrs of observation. All the signs of irritation were recovered after 24 hours.

Clinical Signs

The test compound 85-73-4 applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.