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Administrative data

Description of key information

Both the end point studies indicate that the substance do not have any irritation effect on skin and eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Age:10 to 12 weeks
Sex:Female
Body weight range: 1.80kg±200g
Identification :By cage tag and corresponding colour body marking
No. of animals :Three
Acclimatization:The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
Randomization:After acclimatization and Veterinary examination three females were randomly selected.
Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The 0.5 gm of test compound was applied on a small area (approximately 6 cm2) of intact skin site.
Duration of treatment / exposure:
exposure period of four hours
Observation period:
14 days
Number of animals:
3
Details on study design:
The animals were prepared 24 hrs prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 14 days
Score:
0.5
Max. score:
0.5
Reversibility:
fully reversible
Remarks on result:
other: No skin reaction was observed after four hours patch removal
Other effects:
The test compound 40306-75-0 when applied dermally on New Zealand White rabbit in the amount of 0.5 gm did not produce any clinical signs dermal irritation after 4 hours patch removal.

No serious reaction was observed at the site of application. The second patch was applied on the different shaven back side and removed after one hour. There were no signs of skin reaction observed at this site of application. Finally, a third patch was applied at a different site and was removed after four hour.No skin reactionwas observed after four hours patch removal.Finally, the animal was observed for 14 days, for any irritation and corrosion.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal irritation index of New Zealand white rabbits is calculated as 0.00 and test compound can be classified under non irritant categories. Thus the result obtained from present study reveals that the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid is non irritant to skin of the New Zealand white rabbits when applied to the shaven back intact skin.
Executive summary:

The site of application was observed for skin reaction if any. The intact skin site of application of each animal was observed for signs of erythema and oedema and the responses were scored following Draize’s method at 60 min., 24, 48 and 72 hours after application. In addition to the observation of irritation, all local toxic effects, such as defatting of the skin, and any systemic adverse effects were fully described and recorded.

 Draize Dermal Irritation Scoring System

Erythema and Eschar Formation

Value

Edema Formation

Value

No erythema

0

No edema

0

Very slight erythema (barely

perceptible)

1

Very slight edema (barely

perceptible)

1

Well-defined erythema

2

Slight edema (edges of area

well defined by definite raising)

2

Moderate to severe erythema

3

Moderate edema (raised

approximately 1 mm)

3

Severe erythema (beet redness)

to slight, eschar formation (injuries in depth)

4

Severe edema (raised more

than 1 mm and extending

beyond the area of exposure)

4

Thus, the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid when applied at the dose level of 0.5 gm on shaven back skin of rabbit did not produced any irritation to skin during period of observation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
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
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.
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation :

The dermal irritation index of New Zealand white rabbits is calculated as 0.00 and test compound can be classified under non irritant categories. Thus the result obtained from present study reveals that the test compound 3-acetamido-5-amino-4-hydroxy benzene sulphonic acid is non irritant to skin of the New Zealand white rabbits when applied to the shaven back intact skin. Based on the weight of evidence for the target substance 3-acetamido-5-amino-4-hydroxy benzene sulphonic acid, it is evident that the substance do not have irritation effect on skin.

Eye irritation :

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

Justification for selection of skin irritation / corrosion endpoint:

The end point has been selected since the study is a k1 data conducted by OECD method.

Justification for selection of eye irritation endpoint:

The end point has been selected since the study is a k1 data conducted by OECD method.

Justification for classification or non-classification

The substance will not be considered for classification in any of the irritation activity as the end point data indiactes that

3-acetamido-5-amino-4-hydroxy benzene sulphonic acid is non irritating in nature.