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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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safey assessment report

Data source

Reference
Reference Type:
secondary source
Title:
REPORTS of the Scientific Committee on Cosmetology (seventh series)
Author:
Published by the COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General Telecommunications, Information Industries and Innovation
Year:
1988
Bibliographic source:
Scientific Committee on Cosmetology (seventh series),1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin sensitization study was conducted on guinea pigs to assess the skin sensitization potential of chemical Sodium 4-(3-hydroxy-5-methyl-4-phenylazopyrazol-2-yl)benzenesulphonate (CAS No: 6359-82-6).
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
-Name: Acid yellow 11
- Molecular formula: C16H13N4NaO4S
-Molecular weight: 380.359 g/mol
-Substance type: organic
- InChI: 1S/C16H14N4O4S.Na/c1-11-15(18-17-12-5-3-2-4-6-12)16(21)20(19-11)13-7-9-14(10-8-13)25(22,23)24;/h2-10,15H,1H3,(H,22,23,24);/q;+1/p-1/b18-17+;
-Smiles: N1(c2ccc(S(=O)(=O)[O-])cc2)C([C@@H](\N=N\c2ccccc2)C(=N1)C)=O.[Na+]
- Substance Type: Organic
- Physical State: Solid
Specific details on test material used for the study:
-IUPAC NAME: Sodium 4-(3-hydroxy-5-methyl-4-phenylazopyrazol-2-yl)benzenesulphonate
- Common Name: Acid yellow 11
- Molecular formula: C16H13N4NaO4S
-Molecular weight: 380.359 g/mol
-Substance type: organic
- InChI: 1S/C16H14N4O4S.Na/c1-11-15(18-17-12-5-3-2-4-6-12)16(21)20(19-11)13-7-9-14(10-8-13)25(22,23)24;/h2-10,15H,1H3,(H,22,23,24);/q;+1/p-1/b18-17+;
-Smiles: N1(c2ccc(S(=O)(=O)[O-])cc2)C([C@@H](\N=N\c2ccccc2)C(=N1)C)=O.[Na+]
- 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:
other: Aqueous solution
Concentration / amount:
0.5% (0.1mL)
Day(s)/duration:
5 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: Not specified
Vehicle:
other: Aqueous solution
Concentration / amount:
0.5% (0.1mL)
Day(s)/duration:
No data available
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: 15
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Frequency of applications: 3 times per day on 5 consecutive days
- Duration: 5 consecutive days
- Concentrations: 0.5% (0.1mL)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 4 weeks
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Concentrations: 0.5% (0.1mL)
- Evaluation (hr after challenge): no data available

Challenge controls:
No data available

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
0.5% (0.1mL)
No. with + reactions:
0
Clinical observations:
No skin sensitization was observed in treated guinea pigs.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No skin sensitization was observed in treated guinea pigs.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test material Sodium 4-(3-hydroxy-5-methyl-4-phenylazopyrazol-2-yl)benzenesulphonate (CAS No: 6359-82-6) was considered to be not sensitizing to the skin of treated guinea pigs.

Executive summary:

Skin sensitization study was conducted on guinea pigs to assess the skin sensitization potential of chemical Sodium 4-(3-hydroxy-5-methyl-4-phenylazopyrazol-2-yl)benzenesulphonate(CAS No:6359-82-6).

 

During the induction phase, guinea pigs were induced intradermally with injections of 0.1 mL of 0.5% aqueous solution of test chemical on 3 times per day on 5 consecutive days. After a rest period of 4 weeks, animals were challenged with the same concentration and then observed for allergic effects. The treated guinea pigs did not reveal any sensitization potential. Hence, Sodium 4-(3-hydroxy-5-methyl-4-phenylazopyrazol-2-yl)benzenesulphonate(CAS No:6359-82-6) was considered to be not sensitizing to the skin of treated guinea pigs.