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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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:

Skin sensitization study was conducted by using 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: Guinea pig maximisation test

Principles of method if other than guideline:

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

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Not specified

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

227-022-5

EC Name:

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

Cas Number:

5601-29-6

Molecular formula:

C34H24CrN8O6.H

IUPAC Name:

Chromium(3+) ion hydrogen bis([(6E)-6-{2-[(4Z)-3-methyl-5-oxo-1-phenyl-4 ,5-dihydro-1H-pyrazol-4-ylidene]hydrazin-1 -ylidene}cyclohexa-2,4-dien-1- ylidene]methanebis(olate))

Details on test material:

IUPAC name: chromium(3+) ion hydrogen bis([(6E)-6-{2-[(4Z)-3-methyl-5-oxo-1-phenyl-4 ,5-dihydro-1H-pyrazol-4-ylidene]hydrazin-1 -ylidene}cyclohexa-2,4-dien-1- ylidene]methanebis(olate))
comman name:Acid yellow 121
Molecular formula :C34H24CrN8O6.H
Molecular weight :695.633 g/mol
Substance type:organic
Physical state:solid
Smiles:c12[N]3=N[C@@-]4C(N(N=C4C)c4ccccc4)=O[Cr+3]453([N](=N[C@@-]3C(N(N=C3C)c3ccccc3)=O5)c3c(C(=O)[O-]4)cccc3)[O-]C(c1cccc2)=O
InChI:1S/2C17H13N4O3.Cr/c2*1-11-15(16(22)21(20-11)12-7-3-2-4-8-12)19-18-14-10-6-5-9-13(14)17(23)24;/h2*2-10H,1H3,(H,23,24);/q2*-1;+3/p-1/b2*19-18+;

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

not specified

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

water

Concentration / amount:

0.1 ml of 0.1 % aqueous solution

Day(s)/duration:

5 days

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

intradermal

Vehicle:

water

Concentration / amount:

0.1 ml of 0.1 % aqueous solution

Day(s)/duration:

Not specified

Adequacy of challenge:

not specified

No. of animals per dose:

Not specified

Details on study design:

A. INDUCTION EXPOSURE
- No. of exposures: 3 times/ day for 5 successive days
- Exposure period: not speccified
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Frequency of applications: 3 times a day
- Duration: not specified
- Concentrations: 0.1 ml of 0.1 % aqueous solution

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: not specified
- Exposure period: not specified
- Test groups: not specified
- Control group: not specified
- Site: not specified
- Concentrations: 0.1 ml of 0.1 % aqueous solution
- Evaluation (hr after challenge): not specified

OTHER: challenge treatment was provided 4 weeks after the induction

Challenge controls:

not specified

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Group:

test chemical

Dose level:

0.1 ml of 0.1 % aqueous solution

No. with + reactions:

0

Clinical observations:

No skin allergic reactions were observed.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

No skin allergic reactions were observed. Hence, the test chemical was considered to be not skin sensitizing.

Executive summary:

The skin sensitization potential of test chemical was evaluated using Guinea pig maximization test. The test chemical in induction treatment was subjected onto the skin of guinea pig by intra-cutaneous injections of 0.1 ml of 0.1 % aqueous solution three times per day for 5 successive days followed by one intracutaneous challenge injection of the same solution after 4 weeks of induction treatment. No skin allergic reactions were observed. Hence, the test chemical was considered to be not skin sensitizing.