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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 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

Constituent 1
Chemical structure
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.