Registration Dossier

Administrative data

Description of key information

Skin Irritation:

500 mg of test substance was administered on to the skin of rabbit. Moderate irritation effects were observed. Therefore, the substance 1,3-Phenylenediamine-4-sulfonic acid was considered to be moderately irritanting to rabbit skin.

Eye Irritation:

20 mg of test substance was administered in to the eye of rabbits. Moderate irritation effects were observed after 24 hours. Therefore, the test substance 1,3-Phenylenediamine-4-sulfonic acid was considered to be moderately irritant to rabbit eyes.

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from authorative handbook
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Evaluate irritation effect of 1,3-Phenylenediamine-4-sulfonic acid on rabbit skin.
GLP compliance:
not specified
Test material information:
Composition 1
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No data available
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 h
Observation period:
No data available
Number of animals:
No data available
Details on study design:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Reversibility:
no data
Remarks on result:
other: moderately irritant to rabbit skin
Interpretation of results:
moderately irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The substance 1,3-Phenylenediamine-4-sulfonic acid was considered to be moderately irritant to rabbit skin.
Executive summary:

Skin irritation test was conducted to evaluate the irritation potential of 1,3-Phenylenediamine-4-sulfonic acid.

500 mg of test substance was administered on to the skin of rabbit. Moderate irritation effects were observed. Therefore, the substance 1,3-Phenylenediamine-4-sulfonic acid was considered to be moderately irritant to rabbit skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from authorative handbook
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: refer below principle
Principles of method if other than guideline:
Evaluate irritation effect of 1, 3-Phenylenediamine-4-sulfonic acid in rabbit eye.
GLP compliance:
not specified
Test material information:
Composition 1
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
20 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
No data available
Number of animals or in vitro replicates:
No data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Reversibility:
not specified
Remarks on result:
other: moderately irritant to rabbit eye
Interpretation of results:
moderately irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The substance 1, 3-Phenylenediamine-4-sulfonic acid is considered to be moderately irritant to rabbit eye.
Executive summary:

Eye irritation test was conducted to evaluate the eye irritation potential of 1, 3-Phenylenediamine-4-sulfonic acid. 20 mg of test substance was administered in to the eye of rabbits. Moderate irritation effectswere observed after 24 hours. Therefore, the test substance 1,3-Phenylenediamine-4-sulfonic acid was considered to be moderately irritant to rabbit eyes.

 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

Skin irritation test was conducted (Sax’s Dangerous Properties of Industrial Materials, 12th Edition, 2012) to evaluate the irritation potential of 1,3-Phenylenediamine-4-sulfonic acid.

500 mg of test substance was administered on to the skin of rabbit. Moderate irritation effects were observed. Therefore, the substance 1,3-Phenylenediamine-4-sulfonic acid was considered to be moderately irritating to rabbit skin.

The dermal irritation potential of test article was determined according to the OECD 439 test guideline followed for this study. The Mean % tissue viability compared to negative control (n=3) of the test substance 2,4-diaminobenzenesulphonic acid, CAS No. 88-63-1 was determined to be 94%. 2,4-diaminobenzenesulphonic acid was considered to be not irritating/irritating to the human skin.

A skin irritation test was carried out in rabbits (GESTIS Substance Database,2016) to determine the skin irritation potency of the similar substance 121-­57­-3.

500mg of test sample was applied on rabbits and observations were made. Since the rabbits produced slight irritation reactions within 24 hours, the test sample Sulfanilic acid was considered as irritating on the rabbit skin.

A skin irritation test was carried out by U.S. Environmental Protection Agency, 2014 to evaluate the irritation parameter of the similar substance 88-53-9.

Six New Zealand rabbits were exposed to test chemical via the dermal route to intact and abraded skin at 500 mg under occlusive conditions for 24 hours and were observed until 72 hours. Slight erythema was seen at both abraded and intact skin sites, and very slight edema was seen in one animal. The primary irritation index was 0.3. Since the rabbits produced slight irritation reactions, 2-Amino-5-chloro-4-methylbenzenesulfonic acid (CAS No: 88-53-9) was considered as mildly irritating to rabbit skin.

 

Another skin irritation test was carried out (IUCLID DATASET, 2000) in rabbits to determine the skin irritation potency of the similar substance 88-53-9.

The animals were treated with test chemical at concentration of 500mg for 24hours under occlusion. Since the rabbits produced slight irritation reactions, 2-Amino-5-chloro-4-methylbenzenesulfonic acid can be considered as irritating on rabbit skin.

The dermal irritation potential of test article was determined according to the OECD 439 test guideline followed for this study. The Mean % tissue viability compared to negative control (n=3) of the test substance 2,4-diaminobenzenesulphonic acid, CAS No. 88-63-1 was determined to be 94%. 2,4-diaminobenzenesulphonic acid was considered to be not irritating/irritating to the human skin.

A skin irritation test was carried out U.S. Environmental Protection Agency, 2014 on the similar substance 88-51-7 to observe its irritation efficacy. 

6 male Albino rabbits were exposed to test chemical in saline via the dermal route to intact skin at 500 mg under occlusive conditions for 24 hours and were observed until 48 hours. At 24 hours, slight to mild erythema was seen in 3 animals and at 48 hours, slight erythema was seen in 1 animal.

Hence 2-Chloro-p-toluidine-5-sulfonic acid (CAS No: 88-51-7) can be considered as mildly irritating to the rabbits’ skin.

 

Based on the available information for the target as well as various read across substances,1,3-Phenylenediamine-4-sulfonic acid can be considered a skin irritant.

 

Eye Irritation:

Eye irritation test was conducted (Sax’s Dangerous Properties of Industrial Materials, 12th Edition, 2012) to evaluate the eye irritation potential of 1, 3-Phenylenediamine-4-sulfonic acid.

20 mg of test substance was administered in to the eye of rabbits. Moderate irritation effects were observed after 24 hours. Therefore, the test substance 1,3-Phenylenediamine-4-sulfonic acid was considered to be moderately irritant to rabbit eyes.

The ocular irritation potential of 2,4-Diaminobenzenesulfonic acid was estimated using OECD QSAR toolbox v 3.4

2,4-Diaminobenzenesulfonic acid was estimated to be moderately irritating to rabbit eyes.

 

An eye irritation study was conducted (RTECS -XT6320000; Last updated- 201204) to evaluate irritation potential of the similar substance 88-44-8

500 mg of the test chemical was instilled into the eyes of rabbits and effects were observed for 24 hours. Mild irritation effects were observed after 24 hours of instillation of the test chemical. Therefore, 6 –amino-m-Toluenesulfonic acid was considered to be a mild eye irritant.

An eye irritation study was conducted (RTECS - XT6327000; last updated - 199701) to evaluate irritation potential of the similar substance 88-62-0.

100 mg of the test chemical was instilled into the eyes of rabbits and effects were observed for 24 hours. Moderate irritation effects were observed after 24 hours of instillation of the test chemical. Therefore, 2 –amino-p-Toluenesulfonic acid was considered to be moderately irritating to eyes.

An eye irritation study was conducted (RTECS -WP3895500;last updated: 201403) to evaluate irritation potential of the similar substance 121-57-3.

100 mg of the test chemical was instilled into the eyes of rabbits and effects were observed for 24 hours. Moderate irritation effects were observed after 24 hours of instillation of the test chemical. Therefore, sulphanilic acid was considered to be moderately irritating to eyes.

Based on the available information for the target as well as various read across substances,1,3-Phenylenediamine-4-sulfonic acid was considered to be an eye irritant.

Justification for selection of skin irritation / corrosion endpoint:

data from handbooks

Justification for selection of eye irritation endpoint:

data from handbooks

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Available studies on the 1,3-Phenylenediamine-4-sulfonic acid indicates that it is irritating to skin and eyes.