Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex

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 from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Sensitization to reactive textile dyes in patients with contact dermatitis

Author:

Bianca Maria Manzini, Alberico Motolese, Andrea Conti, Graziella Ferdani and Stefania Seidenari.

Year:

1996

Bibliographic source:

Contact Dermatitis, 1996, 34,172-175

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Skin sensitization study of C.I. Reactive Violet 5 was performed by human Maximization test in human

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

No data available

Test material

Test material information

Constituent 1

Reference substance name:

Copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex

EC Number:

235-434-1

EC Name:

Copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex

Cas Number:

12226-38-9

Molecular formula:

C20H18CuN3Na3O15S4

IUPAC Name:

copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex

Test material form:

solid

Details on test material:

Name of the test chemical: C.I. Reactive Violet 5
IUPAC name: copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex
Molecular formula: C20H18CuN3Na3O15S4
Molecular weight: 799.1324 g/mol
SmilesNotation:c1(S(=O)(=O)CCOS(=O)(=O)[O-])cc2O[Cu]OC3=C(N=Nc2cc1)C(=C[C@@H]1[C@@H]3C(=CC(=C1)S(=O)(=O)[O-])NC(=O)C)S(=O)(=O)[O-].[Na+].[Na+].[Na+]
InChI: 1S/C20H21N3O15S4.Cu.3Na/c1-10(24)21-15-8-13(40(29,30)31)6-11-7-17(41(32,33)34)19(20(26)18(11)15)23-22-14-3-2-12(9-16 (14)25)39(27,28)5-4-38-42(35,36)37;;;;/h2-3,6-9,11,18,25-26H,4-5H2,1H3,(H,21,24)(H,29,30,31)(H,32,33,34)(H,35,36,37);;;;/q;+2;3*+1/p-5/b23-22+;;;;
Substance Type: Organic
Physical State: Solid

Specific details on test material used for the study:

Name of the test chemical: C.I. Reactive Violet 5
IUPAC name: copper, 5-(acetylamino)-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2,7-naphthalenedisulfonic acid complex
Molecular formula: C20H18CuN3Na3O15S4
Molecular weight: 799.1324 g/mol
SmilesNotation:c1(S(=O)(=O)CCOS(=O)(=O)[O-])cc2O[Cu]OC3=C(N=Nc2cc1)C(=C[C@@H]1[C@@H]3C(=CC(=C1)S(=O)(=O)[O-])NC(=O)C)S(=O)(=O)[O-].[Na+].[Na+].[Na+]
InChI: 1S/C20H21N3O15S4.Cu.3Na/c1-10(24)21-15-8-13(40(29,30)31)6-11-7-17(41(32,33)34)19(20(26)18(11)15)23-22-14-3-2-12(9-16 (14)25)39(27,28)5-4-38-42(35,36)37;;;;/h2-3,6-9,11,18,25-26H,4-5H2,1H3,(H,21,24)(H,29,30,31)(H,32,33,34)(H,35,36,37);;;;/q;+2;3*+1/p-5/b23-22+;;;;
Substance Type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:

other: Human

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

Source: Allergological Department, University of Modena, Italy
Age: from 3 to 73 years

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

5.0%

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

5.0%

Adequacy of challenge:

not specified

No. of animals per dose:

1813 patients

Details on study design:

Details on study design
RANGE FINDING TESTS: Final concentration of 5% in petrolatum was chosen after preliminary tests with 4% and 10%

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period:3 days
- Test groups:1813
- Control group: No data available
- Site: The allergens applied on back with Finn Chamber (Epitest Finland ) on Scanpor tape(Norgesplaster, Norway)
- Frequency of applications: No data available
- Duration:3 days
- Concentrations:5.0% in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: at day 4

- Exposure period: No data available
- Test groups:1813
- Control group: No data available
- Site: The allergens applied on back with Finn Chamber (Epitest Finland ) on Scanpor tape(Norgesplaster, Norway)
- Frequency of applications: No data available
- Duration: 3 days
- Concentrations:5.0%
- Evaluation (hr after challenge):3 hr later at 4days.


OTHER: no data available

Challenge controls:

No data available

Positive control substance(s):

not specified

Study design: in vivo (LLNA)

Statistics:

No data available

Results and discussion

Positive control results:

No data available

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

3

Group:

test chemical

Dose level:

5.0%

No. with + reactions:

5

Total no. in group:

1 813

Clinical observations:

5 out of 1813 patients showed positive effect

Remarks on result:

other: positive indication of skin sensitisation observed in 5 out of 1813 patients

In vivo (LLNA)

Cellular proliferation data / Observations:

5 patients showed positive reaction when observed after 3 hr later at 4days.

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

C.I. Reactive Violet 5 (12226-38-9) was considered to be not sensitizing to humans.

Executive summary:

In skin sensitization study, 1813 patients were tested by maximization test to ascertain the degree of sensitization caused by C.I. Reactive Violet 5 (12226-38-9).

1813 patients aged 3 to 73 years underwent patch tests in the Allergological Department, University of Modena, Italy with the GIRDCA standard series. The dye was dispersed in 5% petrolatum, chosen after preliminary studies with 4% and 10%. Patches were applied to healthy skin of the back with Finn Chambers on Scanpor tape. The patches were removed after 3 days and reactions were read 3 hours later at 4 days. Reactions were evaluated according to ICDRG Guidelines.

However it was not known whether the sensitizing components of the reactive dye molecules are the same as those responsible for occupational IgE- mediated and contact allergy, or if they are new groups derived by the end of the dying process. Also no particular association was found between sensitization to reactive dye and sensitization to standard allergens.

Hence. C.I. Reactive Violet 5(12226-38-9)was considered to be not sensitizing to humans.