Registration Dossier
Registration Dossier
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EC number: 614-925-8 | CAS number: 69098-08-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in accordance with GLP; low purity of the test substance (71.2 %)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- methyl 3-methoxy-3-(4-methoxyphenyl)propanoate
- EC Number:
- 614-925-8
- Cas Number:
- 69098-08-4
- Molecular formula:
- C12 H16 O4
- IUPAC Name:
- methyl 3-methoxy-3-(4-methoxyphenyl)propanoate
- Details on test material:
- - Name of test material (as cited in study report): 3-(4-Methoxyphenyl)-3-methoxypropionsaueremethylester, technical grade
- Substance No.: 93/98
- Batch No.: Ansatz 165
- Purity: 71.2 %.
- Date of manufacturing: 22 Apr 1993
- Physical state: solid, brown; after heating at about 30 °C: liquid brown
- Storage condition of test material: REFRIGERATOR, EXCLUSION OF LIGHT AND AIR (UNDER NITROGEN), EXCLUSION OF MOISTURE
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; Offenbach / Main, FRG
- Sex: male
- Age at study initiation: young adult animals
- Weight at study initiation: 2.62, 2.95 and 2.51 kg
- Housing: single in stainles stell wire mesh cages with grating; floor area: 3000 cm2
- Diet: 130 g Kliba-Labordiaet per animal per day
- Water: 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 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the treated animals
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%
The test substance was heated at about 30 deg C to become liquid- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- APPLICATION:
- Area of exposure: test patch 2.5 x 2.5 cm
- The test patch was moistened with a dose of 0.5 ml unchanged, at about 30 deg C heated test substance, and then the test patch was applied to the intact skin. The test patch was secured in position with a semiocclusive dressing.
REMOVAL OF TEST SUBSTANCE
- At the end of the exposure period with Lutrol and Lutrol/water (1/1).
READINGS
- 1, 24, 48 and 72 hours after removal of the patch
SCORING SYSTEM:
Erythema and edema were graded according to the Draize-system as stated in OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h (2/3 animals), 72h (1/3 animals)
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritant effects noted
- Irritant / corrosive response data:
- After 1 hour following removal of the patch, the application site of each rabbit displayed very slight erythema that lasted for 24 hours in two cases and for 48 h in one case. After 72 hours, no more signs of irritation were visible.
Any other information on results incl. tables
Results:
| readings | animal | erythema | edema |
| 1 h | 1 | 1 | 0 |
| 2 | 1 | 0 | |
| 3 | 1 | 0 | |
| 24 h | 1 | 1 | 0 |
| 2 | 1 | 0 | |
| 3 | 1 | 0 | |
| 48 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 1 | 0 | |
| 72 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| mean 24 - 72 h | 1 | 0.3 | 0.0 |
| 2 | 0.3 | 0.0 | |
| 3 | 0.7 | 0.0 | |
| mean | all animals | 0.4 | 0.0 |
Applicant's summary and conclusion
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