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EC number: 484-040-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 January to 22 February 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 406 with deviations: age at study initiation, housing and feeding conditions not reported; isomers ratio not reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- age at study initiation, housing and feeding conditions not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 96/54 E.E.C.
- Deviations:
- yes
- Remarks:
- age at study initiation, housing and feeding conditions not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 21 February 2007
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to REACH regulation, GPMT studies that were carried out or initiated before 10 May 2017 shall be considered appropriate to address this standard information requirement.
Test material
- Reference substance name:
- 4-METHYLENE-2-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-TETRAHYDRO-PYRAN
- Cas Number:
- 947237-93-6
- Molecular formula:
- C15 H24 O
- IUPAC Name:
- 4-METHYLENE-2-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-TETRAHYDRO-PYRAN
- Reference substance name:
- 4-METHYL-6-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-3,6-DIHYDRO-2H-PYRAN
- Cas Number:
- 947237-84-5
- Molecular formula:
- C15 H24 O
- IUPAC Name:
- 4-METHYL-6-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-3,6-DIHYDRO-2H-PYRAN
- Reference substance name:
- 4-METHYL-2-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-3,6-DIHYDRO-2H-PYRAN
- Cas Number:
- 947237-75-4
- Molecular formula:
- C15 H24 O
- IUPAC Name:
- 4-METHYL-2-(2,2,3-TRIMETHYL-CYCLOPENT-3-ENYLMETHYL)-3,6-DIHYDRO-2H-PYRAN
- Test material form:
- liquid
- Details on test material:
- - Physical state: Yellow liquid
- Storage condition of test material: Room temperature, protected from direct sun light
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre de Production Animale (F-45160 Olivet).
- Weight at study initiation: 264-363 g
- Housing: No data
- Diet: No data
- Water: No data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-23 °C
- Humidity: 45-54 %
- Air changes: No data
- Photoperiod: No data
IN-LIFE DATES: 15 January to 22 February 2007
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 25% for the 1st induction
- Day(s)/duration:
- 8 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 100% for the 2nd induction
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- topical application at 50 and 25%
- Day(s)/duration:
- 2-3 days
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- MAIN STUDY:
GROUP 1 (negative control): 5 males
GROUP 2 (treated): 10 males - Details on study design:
- PRELIMINARY STUDIES:
Maximum Non Necrotizing Concentration (M.N.N.C.) determination: 2 female guinea pigs n° C6910 & C6911 were used. The test item was injected by intradermal route at the following concentrations: 100%, diluted at 50%, 25%, 12.5%, 6.25% and 3.125% in olive oil. No necrosis has been observed, since the concentration of 25%, the first induction has been carried out by intradermal injection at the same concentration.
Pre-Maximum Non Irritant Concentration (Pre-M.N.I.C.) determination: 2 female guinea pigs n° C6910 & C6911 were used. The test item was applied under an occlusive dressing during 24 hours, at the following concentrations 100%, diluted at 50%, 25% and 12.5% in paraffin oil. 24 hours after the removal of the occlusive dressings, it was noted a slight erythema on the treated area at 100% in one animal. In view of these results, the concentration selected was 100% for the 2nd induction of the main study and the MNIC determination began at this concentration of 50%.
Maximum Non Irritant Concentration (M.N.I.C.) determination: 3 female guinea pigs n° C6941 to C6943 were used. After induction by intradermal injection with olive oil and by topical application with paraffin oil and a 17-day rest phase, the challenge phase under occlusive dressing for 24 hours consists in a single topical application of the test item at the following concentrations: diluted at 50%, 25%, 12.5% and 6.25% in paraffin oil. 24 hours after removal of the occlusive dressings, no cutaneous reaction was recorded. In view of this result, the concentrations selected were 50% (MNIC) and 25% (1/2 MNIC) for the challenge phase.
MAIN STUDY
Induction phase: The induction phase was performed by intradermal injection at D0 with the test item at 25% and by topical application at D7 with the test item at 100% during 48 hours, 24 hours after brushing with a solution of sodium lauryl sulfate.
A. INDUCTION EXPOSURE (INTRADERMAL - 1st induction: Day 0)
- No. of exposures: One
- 2 intradermal injections of the test item diluted at 25%; 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a physiological saline solution; 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the test item diluted at 50%.
- Exposure period/duration: 8 days
- Concentrations: 25% in olive oil
B. INDUCTION EXPOSURE (TOPICAL - 2nd induction: Day 8)
- No. of exposures: One
- Topical application, on the same zone, with the test item at 100%, 24 hours after brushing with 0.5 mL of a solution of Sodium lauryl sulfate at 10%.
- Duration: 3 days
- Concentrations: 100%
C. REST PHASE: 17 days
D. CHALLENGE EXPOSURE
Challenge phase: The test item has been used at 50% and diluted at 25% in paraffin oil.
- No. of exposures: One
- Day(s) of challenge: Day 27
- Exposure period: 24 and 48 h
- Challenge phase (Groups 1 & 2): topical application under occlusive dressing at the following concentrations: 50% & 25%.
- Evaluation: 24 and 48 h after challenge - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde induced skin sensitisation indicating the validity of the study.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25 and 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- latest historical data (16 January 2007: 13th test)
Any other information on results incl. tables
Sensitising potential assessment: No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item.
No cutaneous intolerance reaction was recorded in animals from the negative control group.
Weight evolution: No abnormality was recorded in the weight growth of both groups.
Mortality: No mortality occurred during this study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test item must not be classified according to CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
- Executive summary:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, induction (intradermic injection at 25% in olive oil and topical application at 100%) of 10 Guinea Pigs of treated group with the test item and a 17-day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test item at 50% and 25% in paraffin oil were performed. The test concentrations for the main study were determined from a preliminary study.
No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item. No cutaneous intolerance reaction was recorded in animals from the negative control group.
The sensitivity of the guinea-pig was checked with known sensitiser i.e., α-Hexylcinnamaldehyde indicating the validity of the study.
Under the test conditions, test item must not be classified according to CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
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