Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-846-5 | CAS number: 88-63-1
Endpoint summary
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
- 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
- Qualifier:
- according to guideline
- 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
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- 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
- 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.
Reference
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
