1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: 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 1

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 2

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

To assess dermal irritation potential of 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride in New Zealand White Rabbits.

GLP compliance:

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 : C13H18ClN5
- Molecular weight : 279.6 g/mol
- Substance type: organic
- Physical state: Powder
- Purity:97.2% by UV-VIS ; 98.8% by HPLC
- 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-]

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

sex:Male and female

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

4 hrs

Observation period:

0.5, 1, 24, 48 and 72 hours

Number of animals:

Total = 3
1 male, 2 females

Details on study design:

TEST SITE
- Area of exposure: back and flanks (6.25cm2)
- % coverage: semi-occlusive dressing.
- Type of wrap if used: No data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: 4 hrs
SCORING SYSTEM: primary irritation index

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema or oedema was observed

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

No erythema or edema was observed after 72 hours. The primary irritation index was 0.0. Based on the scores and observations, 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was considered to be not irritating to rabbit skin.

Executive summary:

The dermal irritation potential of 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was assessed in New Zealand White Rabbits. The study was performed according to OECD 404 Guidelines.

 

2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was applied on the clipped back and flanks of the 3 rabbits(1male and 2 females) to an area of 6.25 cm²under a semi-occlusive dressing. The patches were removed after 4 hours and observations made at 0.5, 1, 24, 48 and 72 hours after removal of patches.

 

No erythema or edema was observed after 72 hours. The primary irritation index was 0.0. Based on the scores and observations, 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was considered to be not irritating to rabbit skin.