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Toxicological information

Skin sensitisation

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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:
secondary source
Title:
REPORTS of the Scientific Committee on Cosmetology (seventh series)
Author:
Published by the COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General Telecommunications, Information Industries and Innovation
Year:
1988
Bibliographic source:
Scientific Committee on Cosmetology (seventh series),1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Guinea pig maximisation test
Principles of method if other than guideline:
To evaluate skin sensitization potential of 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)) on guinea pig .
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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+;
Specific details on test material used for the study:
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:
No data available

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 group
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

In vivo (LLNA)

Cellular proliferation data / Observations:
No skin allergic reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
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)) didnot induce any dermal sensitization reactions in guinea pigs. Hence, 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)) can be considered to be not sensitizing to skin.
Executive summary:

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))was used as a test material to evaluate skin sensitization potential .

The test material 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. 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))  didnot induce any dermal sensitization reactions in guinea pigs. Hence, 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))  can be considered to be not sensitizing to skin.