Registration Dossier
Registration Dossier
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EC number: 227-217-5 | CAS number: 5718-26-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Guinea Pig Maximization Test according to to Magnussen and Kligman
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted 1997
Test material
- Reference substance name:
- Methyl 2-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)ethylidene]-1,3,3-trimethylindoline-5-carboxylate
- EC Number:
- 227-217-5
- EC Name:
- Methyl 2-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)ethylidene]-1,3,3-trimethylindoline-5-carboxylate
- Cas Number:
- 5718-26-3
- Molecular formula:
- C25H25N3O3
- IUPAC Name:
- methyl 1,3,3-trimethyl-2-[2-(3-methyl-5-oxo-1-phenyl-1,5-dihydro-4H-pyrazol-4-ylidene)ethylidene]indoline-5-carboxylate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch No.: A 100941995
Purity: technical grade
solid red powder
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH, Harlan Winkelmann
- Sex:
- male
- Details on test animals and environmental conditions:
- 20 male Guinea pigs; room temperature: 22+/-3 degree Celsius; relative humidity: 40-60%; light dark cyrcle 12 hartificial light; air exchange rate >0 10 times per hour.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 1%
- Day(s)/duration:
- single
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 0.5 ml of a 25% suspension
- Day(s)/duration:
- single
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #10
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 6%
- Day(s)/duration:
- 72 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- Guinea Pig Maximization Test according to to Magnussen and Kligman
- Challenge controls:
- Yes
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- non
- Remarks on result:
- other: control group
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- non
- Remarks on result:
- other: control group
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- non
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Dose level:
- 6%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- non
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The Guinea Pig Maximization Test (GPMT) was performed on male guinea pigs to determine whether the test substance MACROLEX ORANGE R exhibits skin-sensitizing properties.
The study was conducted with the following test substance concentrations:
lntradermal induction: 1 %
Topical induction: 25%
Challenge: 6%
For the induction and the challenge treatment the test substance was formulated in propylene glycol to yield a suspension.
72 hours after the challenge the 6% test substance formulation led to skin reddening (grade 1) in 1/10 (10%) animals in the test group, but not after 48 hours. The challenge with a 6% test substance formulation showed no skin effects in the control group animals.
Under the conditions of the maximization test the test substance thus exhibits no skin-sensitization potential.
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