Registration Dossier
Registration Dossier
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EC number: 264-561-5 | CAS number: 63910-74-7
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:
- 1 988
- 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
- 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+;
Constituent 1
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.
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