1,3-Benzenedisulfonic acid, 4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[6-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-, hexasodium salt

Skin sensitisation

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 journals

Data source

Reference

Reference Type:

publication

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, 1996, 35, 313

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Patch test

Principles of method if other than guideline:

Patch tests were performed on 312 consecutive patients to determine the allergic potential of Reactive Red 198

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance 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)

EC Number:

604-452-5

Cas Number:

145017-98-7

Molecular formula:

C27H22ClN7O16S5.4Na

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)

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): 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)
- Common Name: Reactive Red 198
- Molecular formula :
- Molecular weight : 984.2152 g/mol
- Substance type: organic
- Physical State: Solid (powder)

Specific details on test material used for the study:

- Name of test material (as cited in study report): 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)
- Common Name: Reactive Red 198
- Molecular formula : C27H22ClN7O16S5.Na
- Molecular weight : 984.2152 g/mol
- Substance type: organic
- Physical State: Solid (powder)
- Purchased from: Hoechst

In vivo test system

Test animals

Species:

other: humans

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Department of Dermatology, University of Modena, Italy

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

5% and 10% in petrolatum

Day(s)/duration:

3 days

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

5% and 10%

Day(s)/duration:

3 days

Adequacy of challenge:

not specified

No. of animals per dose:

312 consecutive patients
119 patients were tested with 5% concentration and remaining 193 with 10% concentration

Details on study design:

A. INDUCTION EXPOSURE
- No. of exposures: single exposure
- Exposure period: 3 days
- Test groups: 312
- Control group: number not mentioned
- Site: healthy skin of the back
- Frequency of applications: daily for 3 days
- Duration: 3 days
- Concentrations: 5% - 119 patients; 10% - 193 patients

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: no data available
- Exposure period: 3 days
- Test groups: 312
- Control group: no data available
- Site: healthy skin of the back
- Concentrations: 5% - 119 patients; 10% - 193 patients
- Evaluation (hr after challenge): no data available

OTHER: 312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential.
The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients.

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 chemical

Dose level:

5 and 10%

No. with + reactions:

0

Total no. in group:

312

Clinical observations:

No positive allergic or irritant reactions were observed in the volunteers

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Table: Reactive dyes used for patch testing

Color Index Name	Commercial Name	Structure
Reactive Red 198	Red Remazol RB 133	Azo dye
Reactive Red 180	Brilliant Red, Remazol F3B	Azo dye
Reactive Orange 16	Brilliant Orange, Remazol 3R	Azo dye
Reactive Orange 96	Gold Yellow, Remazol 3R	Azo dye
Reactive Blue 220	Brilliant Blue, Remazol BB	Formazan dye

 

Applicant's summary and conclusion

Interpretation of results:

other: not sensitoxing

Conclusions:

No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye.
Hence, Reactive Red 198 can be considered to not sensitizing to human skin.

Executive summary:

Patch tests were performed on 312 consecutive patients to determine the allergic potential of Reactive Red 198.

312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential.

The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients.

No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye.

Hence, Reactive Red 198 can be considered to not sensitizing to human skin.