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EC number: 617-589-0 | CAS number: 84592-32-5
Toxicological information
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:
- other: According to OECD 406 and Commission Directive 96/54/EC. Study conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- [(5-(4-hydroxy-2,6,6-trimethyl-3-oxo-1-cyclohexen-1-yl)-3-methyl-2,4-pentadienyl](triphenyl)phosphonium bromide
- EC Number:
- 617-589-0
- Cas Number:
- 84592-32-5
- Molecular formula:
- C33 H36 O2 P .Br
- IUPAC Name:
- [(5-(4-hydroxy-2,6,6-trimethyl-3-oxo-1-cyclohexen-1-yl)-3-methyl-2,4-pentadienyl](triphenyl)phosphonium bromide
- Details on test material:
- - NAME OF TEST SUBSTANCE: ASTA-C15-SALZ KRIST.
- CHEMICAL NAME: [5-(4-HYDROXY-2,6,6-TRIMETHYL-3-OXO-1-CYCLOHEXEN-1-YL)-3-METHYL-2, 4-PENTADIENYL]TRIPHENYLPHOSPHONIUMBRO MID
- SUBSTANCE NUMBER: 96/337
- BATCH NUMBER: 95149-4B/TROMMEL 2
- CAS NUMBER: 84592-32-5
- DEGREE OF PURITY/CONTENT: 98 G/ 100 G (HPLC)
- DATE OF MANUFACTURING: 08-NOV-1995
- PHYSICAL STATE/APPEARANCE: SOLID, CRYSTALLINE, OCHRE
- STORAGE CONDITIONS: ROOM TEMPERATURE, EXCLUSION OF LIGHT, MOISTURE AND OXYGEN (STORAGE UNDER NITROGEN).
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Wiga, Kisslegg, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 316 - 393 g
- Housing: together in makrolon cages, type IV.
- Diet (e.g. ad libitum): Kliba Labordiaet 341 (Kaninchen-Meerschweinchen-Haltungsdiaet) ad libitum
- Water (e.g. ad libitum): water ad libitum (tap water; about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week).
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and percutaneous
- Vehicle:
- other: olive oil DAB 10
- Concentration / amount:
- - intradermal induction: 5% test substance
- percutaneous induction: 50% test substance
- challenge: 10% test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: olive oil DAB 10
- Concentration / amount:
- - intradermal induction: 5% test substance
- percutaneous induction: 50% test substance
- challenge: 10% test substance
- No. of animals per dose:
- 10 (control) and 20 (test).
- Details on study design:
- Main test
Number of animais per control group: 10
Number of animais of the test group: 20
Induction
Intradermal induction:
- 6 intradermal injections in groups of two per animal
Injections for the test group:
A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaC1-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 ml of the test substance formulation
C) back row: 2 injections each of 0.1 ml Freund's adjuvant (0.9% aqueous NaCl-solution 1: 1) with test substance
Injections for control groups 1 and 2:
- The animais were given the same injections
Site of application:
- shoulder
Readings:
- 24 h after the beginning of application
Assessment of the skin findings:
- analogous to the pretest
Percutaneous induction:
- Percutaneous induction was carried out one week after intradermal induction.
Amount applied:
2 x 4 cm filter paper strips containing the test substance formulation were applied to the skin of the shoulder under an occlusive ciressing. The filter
paper strip was soaked in the test substance formulation. The dressing consisted of rubberized linen patches (4 x 6 cm from Russka) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
The control groups were treateci analogously to the test group but only with the solvent without the test substance.
Duration of exposure:
- 48 hours
Site of application:
- shoulder, same area as in the case of the previous intradermal application
Readings:
- 48 h after the beginning of application
Assessment of skin findings:
- analogous to the pretest
Challenge
The challenge was performed 14 days after the percutaneous induction.
Amount applied:
2 x 2 cm filter paper strips containing the test substance formulation were applied to the 5 cm2 of the flank under an occlusive dressing. The filter paper strip was soaked in the test substance formulation. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch
The test group and control group 1 were treated with the test substance formulation. Additionally, olive oil DAB 10 was appliedl as a vehicle control to all animais. Control group 2 only received olive oil DAB 10.
Duration of exposure:
- 24 hours
Site of application:
- intact flank
Readings:
- 24 and 48 h after the removal of the patch
Assessment of skin findings:
- analogous to the pretest - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde techn. 85%
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% test substance in olive oil DAB 10
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10% test substance in olive oil DAB 10. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- olive oil DAB 10
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: olive oil DAB 10. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% test substance in olive oil DAB 10
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% test substance in olive oil DAB 10. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- olive oil DAB 10
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: olive oil DAB 10. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% test substance in olive oil DAB 10
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% test substance in olive oil DAB 10. No with. + reactions: 19.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% test substance in olive oil DAB 10
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% test substance in olive oil DAB 10. No with. + reactions: 16.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of this study, the test substance Asta-C15-Salz krist. has a sensitizing effect on the skin of guinea pigs in the Maximization Test. Thus, the test substance needs to be classified according to Regulation (EC) No. 1272/2008.
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