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Description of key information

Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5 -sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6). The studies are as mentioned below:

 

Skin sensitization study was performed by peer reviewed journal for read across chemical in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for read across substance to detect its contact sensitivity.The patch of test chemical was applied onto the back of each patient for24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy) at a dose of 1% in petrolatum. After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days.Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.The negative skin sensitizing effects were observed in all treated patients. Thusthe test chemical was considered to be not sensitizing in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.

 

 The above result was further supported by another patch test conducted by peer reviewed journal for another read across chemical on healthy skin of 321 patients admitted to Allergological Services. The test material was applied on the back of the patients which was installed in Finn chambers on Scanpor tape for the patch test in the concentration 5% on 119 patients and 10% on 193 patients diluted in petrolatum. The exposure duration was 3 days and the observations were made 3 hours after removal of the test material on day 4. The test material produced no skin allergic reaction. Hence, the test chemical was considered to be not skin sensitizing.

 

Based on the above summarized studies for target chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

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 of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across 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 of test chemical was determined by performing patch tests on humans.
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:
1. Not specified
2.- Source: 312 patients admitted to Allergological Services
Route:
other: 1.epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Day(s)/duration:
2 days
Adequacy of induction:
not specified
Route:
other: 2.epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
5% on 119 patients and 10% on 193 patients
Day(s)/duration:
3 days
Adequacy of induction:
not specified
No.:
#1
Route:
other: 1.epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Day(s)/duration:
2 days
Adequacy of challenge:
not specified
No.:
#1
Route:
other: 2.epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
5% on 119 patients and 10% on 193 patients
Day(s)/duration:
3 days
Adequacy of challenge:
not specified
No. of animals per dose:
1.28 healthy female volunteers
2.312 patients
Details on study design:
1.The test was performed with Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). The application was performed on the back for 2 days. Readings were made according to the ICDRG classification 24 h after the patches were removed.

2.The test material was installed in Finn chambers on Scanpor tape for the patch test
A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period: 3 days
- Test groups: 312 patients
- Control group: no data
- Site: back
- Frequency of applications: no data
- Duration: 3 days
- Concentrations: 5% on 119 patients and 10% 0n 193 patients

B. CHALLENGE EXPOSURE
- No. of exposures: no data
- Exposure period: 3 days
- Test groups: 312 patients
- Control group: no data
- Site: back
- Concentrations: 5% on 119 patients and 10% on 193 patients
- Evaluation (hr after challenge): 3 hrs
Challenge controls:
1.Healthy female volunteers which were used as a control are of age 20 and 21.
2.No data available
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
Skin sensitizing effects were not observed.NO
Reading:
1st reading
Hours after challenge:
3
Group:
test chemical
Dose level:
5% on 119 patients and 10% 0n 193 patients
No. with + reactions:
0
Total no. in group:
312
Clinical observations:
No positive allergic reactions were observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) was considered to be not sensitizing to the skin.
Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5 -sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6). The studies are as mentioned below:

 

Skin sensitization study was performed by peer reviewed journal for read across chemical in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for read across substance to detect its contact sensitivity.The patch of test chemical was applied onto the back of each patient for24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy) at a dose of 1% in petrolatum. After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days.Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.The negative skin sensitizing effects were observed in all treated patients. Thusthe test chemical was considered to be not sensitizing in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.

 

 The above result was further supported by another patch test conducted by peer reviewed journal for another read across chemical on healthy skin of 321 patients admitted to Allergological Services. The test material was applied on the back of the patients which was installed in Finn chambers on Scanpor tape for the patch test in the concentration 5% on 119 patients and 10% on 193 patients diluted in petrolatum. The exposure duration was 3 days and the observations were made 3 hours after removal of the test material on day 4. The test material produced no skin allergic reaction. Hence, the test chemical was considered to be not skin sensitizing.

 

Based on the above summarized studies for target chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Data available for the structurally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5 -sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6). The studies are as mentioned below:

 

Skin sensitization study was performed by peer reviewed journal for read across chemical in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for read across substance to detect its contact sensitivity.The patch of test chemical was applied onto the back of each patient for24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy) at a dose of 1% in petrolatum. After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days.Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.The negative skin sensitizing effects were observed in all treated patients. Thusthe test chemical was considered to be not sensitizing in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.

 

 The above result was further supported by another patch test conducted by peer reviewed journal for another read across chemical on healthy skin of 321 patients admitted to Allergological Services. The test material was applied on the back of the patients which was installed in Finn chambers on Scanpor tape for the patch test in the concentration 5% on 119 patients and 10% on 193 patients diluted in petrolatum. The exposure duration was 3 days and the observations were made 3 hours after removal of the test material on day 4. The test material produced no skin allergic reaction. Hence, the test chemical was considered to be not skin sensitizing.

 

Based on the above summarized studies for target chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS No: 84057-71-6) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.