Hydrogen bis[2-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-5-sulphamoylbenzoato(2-)]chromate(1-)

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:

other: secondary source

Title:

To evaluate skin irritation potential of the given test chemical.

Author:

European Commission (EC) - Scientific Committee on Cosmetology (SCC)

Year:

1988

Bibliographic source:

European Commission (EC) - Scientific Committee on Cosmetology (SCC),1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To evaluate skin irritation potential of test chemical on guinea pig .

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxybenzenesulphonato(3-)]chromate(3-)

Cas Number:

6408-26-0

Molecular formula:

C32H20Cl2CrN8O10S2.H.2Na

IUPAC Name:

Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxybenzenesulphonato(3-)]chromate(3-)

Test material form:

solid

Details on test material:

-IUPAC name: Chromium complex of 1-phenyl-3-methyl 4-(2'hydroxy-3'-sulfo-5'-chlorophenylazo) 5-hydroxypyrazole
-Commen name: Acid Red 180
- Molecular formula : C32H20Cl2CrN8O10S2.H.2Na
- Molecular weight :782.537 g/mol
- Substance type:organic
- Physical state:solid
-InChI:1S/2C17H14ClN4O2.Cr.2Na/c2*1-10-8-12(18)9-14(16(10)23)19-20-15-11(2)21-22(17(15)24)13-6-4-3-5-7-13;;;/h2*3-9,23H,1-2H3;;;/q2*-1;+3;2*+1/p-1/b2*20-19+;;;
-Smiles:C=12[C@@-](C(=NN2c2ccccc2)C)N=[N]2c3c([O-][Cr+3]452(O1)O=C1N(N=C([C@@-]1N=[N]5c1c(c(cc(c1)Cl)C)[O-]4)C)c1ccccc1)c(cc(c3)Cl)C.[Na+].[Na+]

Test animals

Species:

guinea pig

Strain:

not specified

Details on test animals or test system and environmental conditions:

not specified

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

other: 1% aqueous solution in 1% methylcellulose

Controls:

not specified

Amount / concentration applied:

1% in aqueous solution

Duration of treatment / exposure:

3 times on day 1, and 3 times on day 2

Observation period:

Not specified

Number of animals:

Not specified

Details on study design:

Not specified

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No skin irritation reaction were observed.

Other effects:

Not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

No dermal reactions were observed even after repeated daily exposures to the test chemical. Hence, the test chemical can be considered to be not irritating to guinea pig skin.

Executive summary:

The skin irritation study of test chemical was conducted on guinea pigs to assess its skin irritation potential in treated guinea pigs. About 1% aqueous solution of the test chemical in 1% methylcellulose was applied on the skin of guinea pigs 3 times on day 1, and 3 times on day 2. The guinea pigs were evaluated daily for dermal reactions.

No dermal reactions were observed even after repeated daily exposures to the test chemical. Hence, the test chemical can be considered to be not irritating to guinea pig skin.