5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride

Skin sensitisation

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 report.

Data source

Reference

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

Materials and methods

Test guideline

Qualifier:

according to guideline

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

Test material information

Constituent 1

Reference substance name:

2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride

EC Number:

278-601-4

EC Name:

2-[[4-(dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride

Cas Number:

77061-58-6

Molecular formula:

C13H18N5.Cl

IUPAC Name:

2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride

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 (if other than submission substance): C13H18ClN5
- Molecular weight (if other than submission substance): 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)

Induction

Induction 1

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

Induction 2

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 chemical

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 amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was considered to be not sensitizing to guinea pig skin.