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Toxicological information

Skin irritation / corrosion

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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

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 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

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: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 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.