Registration Dossier
Registration Dossier
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EC number: 608-516-3 | CAS number: 30720-99-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- methyl (4-butanoyl-2,3-dichlorophenoxy)acetate
- EC Number:
- 608-516-3
- Cas Number:
- 30720-99-1
- Molecular formula:
- C13H14Cl2O4
- IUPAC Name:
- methyl (4-butanoyl-2,3-dichlorophenoxy)acetate
- Test material form:
- solid: crystalline
- Details on test material:
- Name of test material (as cited in study report): Ketoészter
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance):
- Substance type: organic
- Physical state: white crystalline
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2966.67.00 +/- 215.61 g average weight
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h/12h
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (onto 20 cm2 surface)
- Concentration (if solution): -
VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4h, 24h, 48 h, 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 20 cm2
- % coverage: full
- Type of wrap if used: gauze and aluminium foil, nylon foil and linen bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 4 h, 24 h, 48 h, 72 h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: 2,3
- Time point:
- other: 4 h, 24h, 48h, 72 h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 4 h, 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No edema was observed in the treated skin area of the animals, but erythema was observed after 72 hours as well by two animal.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is classified as slightly skin irritant.
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