Registration Dossier
Registration Dossier
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EC number: 205-457-1 | CAS number: 141-10-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 6,10-dimethylundeca-3,5,9-trien-2-one
- EC Number:
- 205-457-1
- EC Name:
- 6,10-dimethylundeca-3,5,9-trien-2-one
- Cas Number:
- 141-10-6
- Molecular formula:
- C13H20O
- IUPAC Name:
- 6,10-dimethylundeca-3,5,9-trien-2-one
- Details on test material:
- - Name of test material (as cited in study report): 2-Pseudojonon
- Lot/batch No.: 89/844; continous production
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, Germany
- Weight at study initiation: males 2.69 and 2.40 kg; female 2.48 kg
- Animal identification: ear tattoo
- Housing: individually in cages made of stainless steel with wire mesh walk floors, floor area 40x51 cm; no bedding in cages, but saw dust in waste trays
- Diet (e.g. ad libitum): Kliba 341 4mm; ca. 130 g/animal/day; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water; ca. 250 ml/animal/day
- Acclimation period: at least 8 days; same housing conditions as during study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 15 days
- Number of animals:
- 2 male, 1 female
- Details on study design:
- TEST SITE
- Area of exposure: upper third of the back or flanks
- clipping: clipping of the fur was at least 15 h befor the beginning of the study
- coverage: 2.5x2.5 cm test patch
- Type of wrap if used: a porous dressing consisting of four layers of absorbent gauze and porous bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1/1)
- Time after start of exposure: 4 h
SCORING SYSTEM:
- time schedule: 30 - 60 min after removal of test patches; 24, 48, 72 h, 8 and 15 days after begin of study
- Evaluation of erythema and edema:
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe
Calculations of the mean acc. to 83/467/EEC criteria of July 29th, 1983
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 15 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.4
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 1 animal, 15 days
Any other information on results incl. tables
Animal 1: male (2.69 kg)
Animal 2: male (2.40 kg)
Animal 3: female (2.48 kg)
Results:
| Readings | Animal | Exposure period: 4 h | ||
| Erythema | Edema | Additional findings | ||
| 4h | 1 | 2 | 1 | |
| 2 | 2 | 2 | ||
| 3 | 2 | 1 | ||
| 24 h | 1 | 3 | 2 | |
| 2 | 3 | 3 | Ed:E | |
| 3 | 3 | 1 | ||
| 48 h | 1 | 3 | 2 | |
| 2 | 3 | 3 | Ed:E | |
| 3 | 3 | 0 | ||
| 72 h | 1 | 3 | 1 | |
| 2 | 3 | 1 | ||
| 3 | 2 | 0 | ||
| 8 d | 1 | 2 | 0 | S |
| 2 | 1 | 0 | S | |
| 3 | 1 | 0 | S | |
| 15 d | 1 | 2 | 1 | S |
| 2 | 1 | 0 | S | |
| 3 | 1 | 0 | S | |
| Mean 24 - 72 h | 1 | 3.0 | 1.7 | |
| 2 | 3.0 | 2.3 | ||
| 3 | 2.7 | 0.3 | ||
| Mean | 2.9 | 1.4 | ||
Additional finding:
- Ed:E: Edema: extending beyond the area of exposure
- S: scaling
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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