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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 safety assessment reports

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Opinion of the SCCNFP on basic red 51
Author:
Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers
Year:
2003
Bibliographic source:
Opinion of the SCCNFP on Basic red 51 during the 25th plenary meeting 2003
Reference Type:
secondary source
Title:
Scientific Committee on Consumer Safety – SCCS- OPINION ON Basic Red 51- COLIPA n° B116
Author:
Scientific Committee on Consumer Safety – SCCS
Year:
2011
Bibliographic source:
Opinion on Basic Red 51, Scientific Committee on Consumer Safety – SCCS, adopted on 22 March 2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
To evaluate the skin sensitization potential of 77061-58-6 (2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride) by Magnusson and Kligman Guinea pig maximisation test
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: particulate/powder
Details on test material:
IUPAC name: 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride
- Commen name: Basic Red 51
- Molecular formula: C13H18ClN5
- Molecular weight : 279.6 g/mol
- Substance type: organic
- Physical state: Powder
- InChI :1S/C13H18N5.ClH/c1-16(2)12-7-5-11(6-8-12)14-15-13-17(3)9-10-18(13)4;/h5-10H,1-4H3;1H/q+1;/p-1
- Smiles :c1([n+](ccn1C)C)\N=N\c1ccc(cc1)N(C)C.[ClH-]
Specific details on test material used for the study:
- IUPAC name: 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride
- Name of test material (as cited in study report): Basic Red 51
- Molecular formula : C13H18ClN5
- Molecular weight :279.6 g/mol
- Substance type: organic
- Physical state: Powder
- Purity : >98%
- Impurities (identity and concentrations): approx 2%
- InChI :1S/C13H18N5.ClH/c1-16(2)12-7-5-11(6-8-12)14-15-13-17(3)9-10-18(13)4;/h5-10H,1-4H3;1H/q+1;/p-1
- Smiles :c1([n+](ccn1C)C)\N=N\c1ccc(cc1)N(C)C.[ClH-]

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino
Sex:
female
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
5% aqueous solution with and without Freund’s Complete Adjuvant
Day(s)/duration:
48 hrs
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
50 %
Day(s)/duration:
48 hrs
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25% aqueous dilution
Day(s)/duration:
24 hrs
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
15 females
Test-10
Control-5
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period: 48 hrs ( epicuteneous induction)
- Test groups: 10
- Control group: 5
- Site: no data
- Frequency of applications: not specified
- Duration: not specified
- Concentrations:
Intradermal induction :5%aqueous solution with and without Freund’s Complete Adjuvant
Epicuteneous induction : 50 %

B. CHALLENGE EXPOSURE
- No. of exposures: not specified
- Day(s) of challenge: 1 day
- Exposure period: 24 hrs
- Test groups: 10
- Control group: 5
- Site: Not specified
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 and 48 hrs

OTHER: challenge treatment was provided 14 days after induction treatment
Challenge controls:
Controls received vehicle only.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No positive skin allergic reactions were observed.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No positive skin allergic reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was subjected to albino guinea pig by intradermal and topical application in induction and challenge treatment . None of the animal produced positive skin allergic reactions . Hence, 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was considered to be not sensitizing to guinea pig skin.
Executive summary:

2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was used as a test material to evaluated its skin sensitization potential by Magnusson and Kligman Guinea pig maximisation test. The test was performed according to OECD guideline 406.

The test material was subjected to the guinea pig by intadermal and topical induction . In intradermal induction 5% aqueous solution with and without

Freund’s Complete Adjuvant was subjected to test animal whereas, in topical induction ,50% preparation of test material under occlusion for 48 hours. Controls received vehicle only.

After 14 days of induction challenge dode was introduced on the guinea pigs by exposing 25% aqueous dilution of the test substance for 24 hours under occlusion. Animals were observed after 24 and 48 hrs

None of the animals of the control or test group were observed with skin reactions after challenge with a non-irritating preparation of 25% of the test material . Hence,2-[[4-(Di-methyl aminophenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was considered to be not sensitizing to guinea pig skin.