4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline

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 Type:

secondary source

Title:

Scientific Committee on Consumer Safety- SCCS - Opinion on the test chemical

Author:

Scientific Committee on Consumer Safety- SCCS

Year:

2010

Bibliographic source:

SCCS -Scientific Committee on Consumer Safety, September 2010

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 the dermal irritation piotential of the test chemical

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-(4'-aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl)aminobenzene

EC Number:

600-539-7

Cas Number:

104226-21-3

Molecular formula:

C17H22N4O2

IUPAC Name:

1-(4'-aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl)aminobenzene

Test material form:

solid

Details on test material:

Name of the test chemical: 1-(4'-aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl)aminobenzene
Common Name: HC Yellow 7
Molecular formula :C17H22N4O2
Molecular Weight:314.387 g/mol
Substance Type: Organic
Physical State: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

sex: female

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

500 mg moistened with water

Duration of treatment / exposure:

4 hours

Observation period:

1,24,48 and 72 hours

Number of animals:

3 female

Details on study design:

TEST SITE
Area of exposure: dorsal area of the trunk
% coverage: no data
Type of wrap if used: No data

REMOVAL OF TEST SUBSTANCE
Washing (if done): no

SCORING SYSTEM: The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches.

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

There were no skin reactions. Brown/yellow skin discolouration was observed at the 1-hour time-point but did not prevent the accurate assessment of erythema.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

No signs of irritation were noted on the rabbit skin. Based on the observations,the test chemical can be considered not irritating to rabbit skin.

Executive summary:

The dermal irritation potential of the test chemical was assessed in rabbits. The study was performed in accordance with OECD 404.

One day prior to the application of the test chemical,the dorsal area of the trunk of 3 female New Zealand White rabbits was clipped free of fur. 500 mg of the test chemical was moistened with water was applied clipped skin of 3 rabbits under semi-occlusive conditions for 4 hours. Subsequently, the dressings were removed, any residual test substance was wiped off. The skin was examined for erythema, eschar formation and edema at 1, 24, 48 and 72 hours after removal of the patches.

No signs of irritation were noted on the rabbit skin.Brown/yellow skin discolouration was observed at the 1-hour time-point but did not prevent the accurate assessment of erythema.

Based on the observations, the test chemical can be considered not irritating to rabbit skin.