Registration Dossier
Registration Dossier
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EC number: 617-589-0 | CAS number: 84592-32-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 404 and EEC Directive 92/69, B.4. 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 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 2.20 - 2.49 kg
- Housing: stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day).
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- other: untreated skin of the test animals.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged material (but moistened)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: semiocclusive
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and lutrol/water (1:1)
- Time after start of exposure: 4
SCORING SYSTEM: as described in the guideline. Readings 1; 24; 48; and 72 h after the application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- other: animal #1, #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions chosen and considering the described findings ASTA-C15-Salz krist. does not give indication of an irritant property to the skin. Thus, no classification is needed according to Regulation (EU) No. 1272/2008.
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