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

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

2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was applied on the back and flank of New Zealand white Rabbit in concentration 0.5 g. No erythema or oedema was observed . The primary irritation index was 0.0. Hence , 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was considered to be not irritating to rabbit skin.

Executive summary:

2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was used as a test material to evaluate skin irritation potential of New Zealand white Rabbit . The study was conducted according to guideline 404 (1981). The test material was applied on the clipped back and flanks of the rabbits 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.

No erythema or oedema was observed. The primary irritation index was 0.0. Hence, 2-[[4-(Di-methyl amino)phenyl] azo]-1,3-dimethyl-1H-imidazolium chloride was considered to be not-irritating to the rabbit skin.