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Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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

 

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

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.

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

Eye irritation

Link to relevant study records
Reference
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.

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.