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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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 group
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.