Registration Dossier
Registration Dossier
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EC number: 202-947-7 | CAS number: 101-50-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Principles of method if other than guideline:
- The data predicted using the Danish (Q)SAR Database
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Irritation parameter:
- other: estimated
- Basis:
- mean
- Remarks on result:
- other: non irritating
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin irritation was estimated to be not irritating on rabbits for 4-aminoazobenzene-3,4'-disulphonic acid.
- Executive summary:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin irritation was estimated to be not irritating on rabbits for 4-aminoazobenzene-3,4'-disulphonic acid. Thus it can be concluded that the substance 4-aminoazobenzene-3,4'-disulphonic acid has negative skin irritation effects and it can be classified as not irritating to skin irritation.
Reference
| Exp | Battery | CASE Ultra | Leadscope | SciQSAR |
Severe Skin Irritation in Rabbit |
| NEG_IN | INC_OUT | NEG_IN | NEG_IN |
Allergic Contact Dermatitis in Guinea Pig and Human | NA | POS_IN | POS_IN | POS_OUT | POS_IN |
Respiratory Sensitisation in Humans |
| POS_IN | POS_IN | POS_IN | POS_IN |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation
- Remarks:
- other: Standard Draize Test
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from authorative handbook and reliable database
- Principles of method if other than guideline:
- Data is from SAX and RTECS
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 24H
- Observation period (in vivo):
- No data available
- Number of animals or in vitro replicates:
- No data available
- Details on study design:
- No data available
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24h
- Reversibility:
- not specified
- Remarks on result:
- other: Mild irritation
- Irritant / corrosive response data:
- No data available
- Other effects:
- No data available
- Interpretation of results:
- other: Mildly irritant
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The 4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8) was found to be mildly irritating to eye of rabbit.
- Executive summary:
4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8) was administered to eye of rabbit at 500 mg of concentration for 24 hrs. Mild irritation was observed after 24 hrs.
Therefore, the 4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8) was found to be mildly irritating to eye of rabbit.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The skin irritation potential for4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8)is estimated using OECD QSAR toolbox version 3.3.The substance 4-aminoazobenzene-3, 4’-disulphonic acid is estimated to be not irritating to the skin of rabbit.
Based on the QSAR prediction done using the Danish (Q) SAR Database, the skin irritation was estimated to be not irritating on rabbits for 4-aminoazobenzene-3, 4’-disulphonic acid. Thus it can be concluded that the substance 4-aminoazobenzene-3, 4’-disulphonic acid has negative skin irritation effects and it can be classified as not irritating to skin irritation.
On the basis of available information for the target and applying weight of evidence approach, the test substance can be considered as not irritating to the skin .
Eye irritation
Eye irritation study by (Richard J. Lewis, Sr., 2007) for 4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8) was observed in rabbit. The test substance was administered to eye of rabbit at 500 mg of concentration for 24 hrs. Mild irritation was observed after 24 hrs.Therefore, the 4 Aminoazobenzene-3, 4’-disulfonic acid (101-50-8) was found to be mildly irritating to eye of rabbit.
The eye irritation potential for4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8)is estimated using OECD QSAR toolbox version 3.3.The substance 4-aminoazobenzene-3, 4’-disulphonic acid is estimated to be irritating to the eye of rabbit.
Eye irritation study by (National Institute for Occupational Safety and Health,1981) for 4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8) was observed in rabbit. Eye irritation test was performed on rabbit using 4-aminoazobenzene-3, 4'-disulfonic acid. After 24 hrs the rabbit was observed and found that the eye was severely irritating. Therefore, on the basis of above experiment the end point for 4-aminoazobenzene-3, 4'-disulfonic acid (101-50-8) was found to be severely irritating to rabbit.
On the basis of available information for the target and applying weight of evidence approach, the test substance can be considered as irritating to the eye.
Justification for selection of skin irritation / corrosion endpoint:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin irritation was estimated to be not irritating on rabbits for 4-aminoazobenzene-3,4'-disulphonic acid. Thus it can be concluded that the substance 4-aminoazobenzene-3,4'-disulphonic acid has negative skin irritation effects and it can be classified as not irritating to skin irritation.
Justification for selection of eye irritation endpoint:
4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8) was administered to eye of rabbit at 500 mg of concentration for 24 hrs. Mild irritation was observed after 24 hrs.
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
The test substance 4-aminoazobenzene-3, 4’-disulphonic acid cannot be classified as skin irritant, while it can be classified as eye irritant.
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