7-benzamido-4-hydroxynaphthalene-2-sulphonic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

data from experimental reports following standard testing procedures

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

To assess the ocular irritation potential of 3-acetamido-5-amino-4-hydroxybenzenesulfonic acid in rabbits according to OECD 405 Guidelines

GLP compliance:

not specified

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 g/mol

Specific details on test material used for the study:

- Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24 g/mole
- InChI: 1S/C8H10N2O5S/c1-4(11)10-7-3-5(16(13,14)15)2-6(9)8(7)12/h2-3,12H,9H2,1H3,(H,10,11)(H,13,14,15)
- 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
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

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.

Duration of post- treatment incubation (in vitro):

no data available

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:

other: Eye irritation scoring index

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

0.1

Reversibility:

not specified

Remarks on result:

no indication of irritation

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.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid produced some blood vessels of conjunctiva were observed hyperemic at 1 hour after the application of test substance.
3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be considered not irritating to the eyes of New Zealand white rabbit under test conditions.

Executive summary:

The ocular irritation potential of 3-acetamido-5-amino-4-hydroxybenzenesulfonic acid was assessed in rabbits. The study was performed according to OECD 405 Guidelines. 0.1 gm of

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid was moistened with distilled water and then placed in the conjunctival sac of one eye of 3 female New Zealand Whtie rabbits 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 remained untreated, served as control.The eyes of the test animal were not washed for at least 24 hours following instillation of the test compound. The eyes were examined at 1, 24, 48 and 72 hours after test substance application.

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid produced some blood vessels of conjunctiva were observed hyperemic at 1 hour after the application of test substance. 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be considered not irritating to the eyes of New Zealand white rabbit under test conditions.