4,4'-diaminostilbene-2,2'-disulphonic acid

Endpoint summary

Description of key information

Skin sensitisation

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data from various test chemicals

Justification for type of information:

Data is summarized based on the available information from various test chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization test was conducted on humans to determine the potential of skin sensitization caused by the chemical.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Species:

other: Human

Strain:

other: not applicable

Sex:

not specified

Details on test animals and environmental conditions:

not specified

Route:

epicutaneous, occlusive

Vehicle:

other: soap plus borate solution

Remarks:

2

Concentration / amount:

3% of the test chemical

Day(s)/duration:

21 Days

Adequacy of induction:

not specified

Route:

epicutaneous, occlusive

Vehicle:

other: detergent base solution

Remarks:

3

Concentration / amount:

The test material (a 0.5% aqueous solution of a detergent mixture containing 10% chemical) was applied.

Day(s)/duration:

3 week

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: soap plus borate

Remarks:

2

Concentration / amount:

Not Specifed

Day(s)/duration:

24 hours

Adequacy of challenge:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: detergent base solution

Remarks:

3

Concentration / amount:

The test material (a 0.5% aqueous solution of a detergent mixture containing 10% chemical) was applied.

Day(s)/duration:

2 weeks after induction

Adequacy of challenge:

not specified

No. of animals per dose:

2. 72 subjects
3. 70 human subjects

Details on study design:

2. No Data Available
3. MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data
- Exposure period: 3 week period
- Test groups: No data
- Control group: The vehicle also was applied as a negative control.
- Site: occlusive patches
- Frequency of applications: series of 9 applications
- Duration: 24 hours'
- Concentrations: 0.5% aqueous solution of a detergent mixture containing 10% chemical

B. CHALLENGE EXPOSURE
- No. of exposures: No data
- Day(s) of challenge: Challenge applications were made 2 weeks later.
- Exposure period: No data
- Test groups: No data
- Control group: The vehicle also was applied as a negative control.
- Site: occlusive patches
- Concentrations: 0.5% aqueous solution of a detergent mixture containing 10% chemical

Challenge controls:

2. Soap plus borate
3. The vehicle also was applied as a negative control.

Positive control substance(s):

no

Remarks:

No positive control was applied.

Positive control results:

No Data Available

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

3% of the test chemical

No. with + reactions:

0

Total no. in group:

72

Clinical observations:

No Clinical observations were seen in the subjects.

Remarks on result:

no indication of skin sensitisation

Remarks:

2

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5%

No. with + reactions:

0

Total no. in group:

70

Clinical observations:

No skin sensitization was observed

Remarks on result:

no indication of skin sensitisation

Remarks:

3

Interpretation of results:

other: Not sensitizing

Conclusions:

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

Executive summary:

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

A skin sensitization study was performed using the test chemical on human subjects so as to identify the sensitizing potential of the test chemical. The test material (3% of the test chemical in a soap plus borate solution was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 72 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The test application sites were graded for primary irritation at various intervals. The material did not appear to cause irritation. None of the subjects were sensitized. Hence, based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.

 

The above study was supported with another skin sensitization study conducted using the given test chemical in humans by patch test. The test chemical (10% brightener in a detergent base solution) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The detergent base contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. No skin sensitization was observed in this study. Hence, the given test chemical is not likely to be skin sensitizing to the human skin.

 

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitization

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

A skin sensitization study was performed using the test chemical on human subjects so as to identify the sensitizing potential of the test chemical. The test material (3% of the test chemical in a soap plus borate solution was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 72 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The test application sites were graded for primary irritation at various intervals. The material did not appear to cause irritation. None of the subjects were sensitized. Hence, based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.

 

The above study was supported with another skin sensitization study conducted using the given test chemical in humans by patch test. The test chemical (10% brightener in a detergent base solution) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The detergent base contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. No skin sensitization was observed in this study. Hence, the given test chemical is not likely to be skin sensitizing to the human skin.

 

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

 

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.