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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Remarks:
read across data
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 assessement report

Data source

Reference
Reference Type:
secondary source
Title:
Environment and Quality of Life - Reports (Seventh Series) for test chemical
Author:
European Commission (EC) - Scientific Committee on Cosmetology (SCC)
Year:
1988
Bibliographic source:
Environment and Quality of Life - Reports (Seventh Series) for test chemical European Commission (EC) - Scientific Committee on Cosmetology (SCC) 1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guinea pig maximisation test
Principles of method if other than guideline:
To evaluate skin sensitization potential of test chemical on guinea pig skin.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate
EC Number:
218-326-9
EC Name:
Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate
Cas Number:
2118-39-0
Molecular formula:
C26H15N5Na4O12S4
IUPAC Name:
Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate
Test material form:
solid
Details on test material:
- Name of test material : Food Black 2
- Molecular formula : C26H19N5O13S4.4Na
- Molecular weight : 809.651 g/mol
- Substance type: organic
- Physical state: solid
InChI: 1S/C26H19N5O12S4.4Na/c27-20-12-18-13(9-23(20)46(38,39)40)10-24(47(41,42)43)25(26(18)32)31-30-22-8-7-21(17-6-3-15(44(33)34)11-19(17)22)29-28-14-1-4-16(5-2-14)45(35,36)37;;;;/h1-12,32H,27H2,(H,33,34)(H,35,36,37)(H,38,39,40)(H,41,42,43);;;;/q;4*+1/p-4/b29-28+,31-30+;;;;
Smiles:c1(S(=O)(=O)[O-])c(\N=N\c2c3c(ccc(S(=O)[O-])c3)c(\N=N\c3ccc(S(=O)(=O)[O-])cc3)cc2)c(O)c2c(c1)cc(S(=O)(=O)[O-])-])c(N)c2.[Na+].[Na+].[Na+].[Na+]
Specific details on test material used for the study:
- Name of test material : Food Black 2
- Molecular formula : C26H19N5O13S4.4Na
- Molecular weight : 809.651 g/mol
- 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:
Not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1 ml of 0.05-0.1%
Day(s)/duration:
21 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: Not specified
Vehicle:
not specified
Concentration / amount:
No data available
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
Not specified
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 doses
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Frequency of applications: 10 doses in 21 days
- Duration: 21 days
- Concentrations: 1 ml 0.05-0.1%

B. CHALLENGE EXPOSURE
- No. of exposures: Not specified
- Day(s) of challenge: 1
- Exposure period: Not specified
- Test groups: Not specified
- Control group: Not specified
- Site: Not specified
- Concentrations: Not specified
- Evaluation (hr after challenge ): Not specified


OTHER: Challenge was provided 14 days after induction
Challenge controls:
Not specified
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
1 ml 0.05-0.1%
No. with + reactions:
0
Clinical observations:
No skin allergic reactions were observed.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
Test chemical when injected to guinea pig skin in the concentration 0.05-0.1% 10 doses in isotonic saline and challenged after 14 days produced no skin allergic reaction .Hence, the test chemical was considered to be not sensitizing to guinea pig skin.
Executive summary:

The read across substance Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (CAS no.2118 -39 -0, E.C. no.: 218 -326 -9) was used as a test material to evaluate skin sensitization potential on guinea pig skin .The test material was given sub-cuteneously in the concentration 1 ml 0.05 -0.1% in isotonic saline , 10 doses for 21 days . Challenge test was provided 14 days after induction . No skin allergic reactions were observed. Hence , the test chemical was considered to be not sensitizing to guinea pig skin.