4-acetamido-5-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]anthranilic acid, sodium salt

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:

guideline study with acceptable restrictions

Justification for type of information:

data is from experimental reports following standard operating 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 parameter of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in accordance with OECD 405

GLP compliance:

no

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/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

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:

TEST ANIMALS
- Sex: female
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2.00 kg±200 gms
- Housing:animals were housed individually in stainless steel cages provided with steel mesh bottom and facilities for food and water
- Diet (e.g. ad libitum): Pelleted feed supplied by Pranav Agro
- Water (e.g. ad libitum): Community tap water kept in glass bottles, ad libitum
- Acclimation period: The healthy rabbits selected for study were acclimatized to laboratory conditions 24 hours prior to testing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 -25 deg C
- Humidity (%): 40-60%
- Air changes (per hr): air conditioned rooms with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark cycle

Test system

Vehicle:

water

Controls:

yes

Amount / concentration applied:

0.1 gm of test chemical moistened with water

Duration of treatment / exposure:

the eyelids were gently pulled together for about one second to prevent loss of material

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 female rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM:Scale of weighted scores for grading the severity of ocular lesions developed by Draize et al
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: hand-slit lamp
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.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

1.25

Max. score:

110

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test compound didnot produce any irritation through out the observation period. However, some blood vessels observed hyperemic upto 24 hours after application of test compound. There were no other signs of irritation observed throughout the observation period of 21 days.

Other effects:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity throughout the examination period of 21 days.

Any other information on results incl. tables

TABLE- 1     GRADING OF OCULAR LESIONS

 

S.NO/ SEX		OBSERVATION	Score				Total	Total Score
1/F			1 hr	24hrs	48 hrs	72 hrs
	Cornea	A.       Opacity-Degree of Density	0	0	0	0	0	0×0×5=0
		B.       Area of Cornea Involved	0	0	0	0	0
	Iris	A.       Values	0	0	0	0	0	0
	Conjunctivae	A.       Redness	1	0	0	0	1	1+0+0×5=5
		B.       Chemosis	0	0	0	0	0
		C.       Discharge	0	0	0	0	0
2/F	Cornea	A.       Opacity-Degree of Density	0	0	0	0	0	0×0×5=0
		B.       Area of Cornea Involved	0	0	0	0	0
	Iris	A.       Values	0	0	0	0	0	0
	Conjunctivae	A.       Redness	1	0	0	0	1	1+0+0×5=5
		B.       Chemosis	0	0	0	0	0
		C.       Discharge	0	0	0	0	0
3/F	Cornea	A.       Opacity-Degree of Density	0	0	0	0	0	0×0×5=0
		B.       Area of Cornea Involved	0	0	0	0	0
	Iris	A.       Values	0	0	0	0	0	0
	Conjunctivae	A.       Redness	1	0	0	0	1	1+0+0×5=5
		B.       Chemosis	0	0	0	0	0
		C.       Discharge	0	0	0	0	0
Grand total								15.00
Mean								5.0
Eye Irritation Scoring index								1.25

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The overall irritation index of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid was 1.25 after 72 hours.
Also 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity throughout the examination period of 21 days.
Hence, under the test conditions, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be concluded to be not irritating to New Zealand White rabbit eyes.

Executive summary:

An ocular irritation study was conducted on New Zealand white rabbits in accordance with OECD 405 to assess the irritation parameter of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid. 3 female New Zealand White rabbits were used for the study. 0.1 gm of the test chemical was moistened with water was instilled in the conjunctival sac of rabbits after gently pulling the lower lid away from the eyeball. The other eye which remained untreated served as a control. The ocular lesions were evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reactions (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were 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. Individual animal weights before and during the study was observed.

The overall irritation index of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid was 1.25 after 72 hours.

Also 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity throughout the examination period of 21 days.

Hence, under the test conditions, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be concluded to be not irritating to New Zealand White rabbit eyes.