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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Title: A study of 5 newly patch-tested reactive textile dyes.
Author:
Bianca Maria Manzini, Massimo Donini , Alberico Motolese and Stefania Seidenari
Year:
1996
Bibliographic source:
Contact Dermatitis volume 35 page no. 313 1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate skin sensitization potential of 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino] -4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl] sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) on 312 patients
GLP compliance:
not specified
Type of study:
other: Human patch test
Justification for non-LLNA method:
Not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material : Reactive Red 198
-IUPAC name: 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4 -[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)
- Molecular formula (if other than submission substance): C27H22ClN7O16S5.4Na
- Molecular weight (if other than submission substance): 984.2152 g/mol
- Substance type: organic
- Physical state: solid
InChI::1S/C27H22ClN7O16S5.4Na/c28-25-31-26(29-16-2-1-3-18(12-16)53(39,40)41)33-27(32-25)30-20-13-19(54(42,43)44)10-14-11-21(55(45,46)47)23(24(36)22(14)20)35-34-15-4-6-17(7-5-15)52(37,38)9-8-51-56(48,49)50;;;;/h1-7,10-13,36H,8-9H2,(H,39,40,41)(H,42,43,44)(H,45,46,47)(H,48,49,50)(H2,29,30,31,32,33);;;;/q;4*+1/p
Specific details on test material used for the study:
- Name of test material : Reactive Red 198
-IUPAC name: 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy- 3-[2-[4-[[2-(sulfooxy)ethyl] sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)
- Molecular formula (if other than submission substance): C27H22ClN7O16S5.4Na
- Molecular weight (if other than submission substance): 984.2152 g/mol
- Substance type: organic
- Physical state: solid
InChI::1S/C27H22ClN7O16S5.4Na/c28-25-31-26(29-16-2-1-3-18(12-16)53(39,40)41)33-27(32-25)30-20-13-19(54(42,43)44)10-14-11-21(55(45,46)47)23(24(36)22(14)20)35-34-15-4-6-17(7-5-15)52(37,38)9-8-51-56(48,49)50;;;;/h1-7,10-13,36H,8-9H2,(H,39,40,41)(H,42,43,44)(H,45,46,47)(H,48,49,50)(H2,29,30,31,32,33);;;;/q;4*+1/p

In vivo test system

Test animals

Species:
other: Human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
- Source: 312 patients admitted to Allergological Services

Study design: in vivo (non-LLNA)

Induction
Route:
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
Challenge
No.:
#1
Route:
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:
312 patients
Details on study design:
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:
No data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
3
Group:
test group
Dose level:
5% on 119 patients and 10% on 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

In vivo (LLNA)

Cellular proliferation data / Observations:
No positive allergic reactions were observed

Any other information on results incl. tables

The test material was installed in Finn chambers on Scanpor tape for the patch test

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) when applied as a patch test on healty skin of 321 patients in the concentration 5% on 119 patients and 10% on 193 patients in petrolatum produced no skin allergic reaction. Hence, 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) was considered to be not skin sensitizing.
Executive summary:

2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]- 1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy) ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) was used as a test material to evaluate skin sensitization potential on healty skin of 321 patientsadmitted 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 hrs after removal of the test material on day 4

The test material produced no skin allergic reaction. Hence, 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino] -1,3,5-triazin-2-yl]amino]-4-hydroxy- 3 - [2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) was considered to be not skin sensitizing.