3-acetamido-5-amino-4-hydroxybenzenesulphonic acid

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:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid

EC Number:

254-879-2

EC Name:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid

Cas Number:

40306-75-0

Molecular formula:

C8H10N2O5S

IUPAC Name:

3-acetamido-5-amino-4-hydroxybenzenesulfonic acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24

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
Acclimatization : The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.
No. of animals: Three

Test system

Vehicle:

water

Controls:

yes, concurrent vehicle

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.

Number of animals or in vitro replicates:

3

Details on study design:

The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in the amount of 0.1 gm moistened with distilled water and then placed in the conjunctival sac of one eye of each animal after gentle pulling the lower eye lid away from the eye ball. The eye lids were then gently held together for about one second to prevent the loss of the material. The other eyes which remains untreated, served as control.The eyes of the test animal did not washed for at least 24 hours following instillation of the test compound.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 21 days

Score:

0.1

Max. score:

0.1

Reversibility:

fully reversible

Irritant / corrosive response data:

The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm produced some blood vessels of conjunctiva were observed hyperemic at 1 hours after the application of test substance.

Other effects:

However, some blood vessels observed hyperemic upto 24 hours after the application of test compound. There were no other signs observed throughout the observation period of 21 days.

Any other information on results incl. tables

CORNEA

 A.Opacity: degree of density (readings should be taken from most dense area)*

OBSERVATION	SCORE
No ulceration or opacity	0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible	1
Easily discernible translucent area; details of iris slightly obscured	2
Nacrous area; no details of iris visible; size of pupil barely discernible	3
Opaque cornea; iris not discernible through the opacity	4

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

From the result obtained from present study, it can be concluded that the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid is non-irritant to the eyes of New Zealand white rabbit under test condition.

Executive summary:

The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid, when applied to conjunctival sac of rabbit in the amount of0.1 gmdid not produces any eye irritation or inflammation. Furthermore, no other clinical signs were recorded after application of test compound such as cage side activity, pain etc. In the confirmatory test, the test compound 3-acetamido-5-amino-4-hydroxy benzene sulphonic acid when applied to the conjunctival sac of the rabbits did not produce eye irritation during the entire observation period. However, some blood vessels observed hyperemic upto 24 hours after the application of test compound. There were no other signs observed throughout the observation period of 21 days.

 

Based on above findings, it can be concluded that the test compound is practically non-irritant at the tested dose level.