Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assessment reports

Data source

Reference

Reference Type:

secondary source

Title:

Reports of the Scientific Committee on Cosmetology

Author:

Commission of the European Communities

Year:

1988

Bibliographic source:

Scientific Committee on Cosmetology (seventh series), European Communities, 1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To determine the skin sensitizing potential of the test chemial in guinea pig.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

no data available

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

EC Number:

223-098-9

EC Name:

Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

Cas Number:

3734-67-6

Molecular formula:

C18H13N3Na2O8S2

IUPAC Name:

disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate

Constituent 2

Reference substance name:

Acid Red 1 (Red 2G)

IUPAC Name:

Acid Red 1 (Red 2G)

Test material form:

solid: particulate/powder

Details on test material:

Name of test material (as cited in study report): Acid Red 1 [Red 2G]
Molecular formula : C18H15N3O8S2.2Na
Molecular weight : 509.426 g/mol
Smiles notation : c12c(cc(S(=O)(=O)[O])c(c2O)\N=N\c2ccccc2)cc(S(=O)(=O)[O])cc1NC(C)=O.[Na+].[Na+]
InChl : 1S/C18H15N3O8S2.2Na/c110(22)1914913(30(24,25)26)711815(31(27,28)29)17(18(23)16(11)14)2120125324612;;/h29,23H,1H3,(H,19,22)(H,24,25,26)(H,27,28,29);;/q;2*+1/p2/b2120+;;
Substance type: Organic
Physical state: Solid

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data available

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1 ml of a 7.5% solution in saline

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1 ml of a 7.5% solution in saline

Adequacy of challenge:

not specified

No. of animals per dose:

no data available

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
No. of exposures: 2 times 4 intradermal injections
Exposure period: No data
Test groups: No data
Control group: No data
Site: No data
Frequency of applications: 2 times
Duration: No data
Concentrations: 0.1 ml of 7.5% solution in saline

B. CHALLENGE EXPOSURE
No. of exposures: single
Day(s) of challenge: 14 days after second intradermal injection
Exposure period: No data
Test groups: No data
Control group: No data
Site: No data
Concentrations: 3% solution in saline
Evaluation (hr after challenge): No data

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

Group:

test chemical

Dose level:

7.5% in saline

No. with + reactions:

0

Clinical observations:

No sensitization observed

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

The intradermal induction and challenge did not reveal any signs of sensitisation.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitising

Conclusions:

The test chemical was considered to be non sensitizing after challenge exposure in guinea pig.

Executive summary:

A sensitization test was carried out in guinea pigs to determined the sensitizing potential of the test chemical. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted.

In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs.

Signs of sensitization were not observed. Hence, the test chemical was considered  to be non sensitizing after challenge exposure in guinea pig.