Registration Dossier
Registration Dossier
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EC number: 203-079-1 | CAS number: 103-09-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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:
- 2-ethylhexyl acetate
- EC Number:
- 203-079-1
- EC Name:
- 2-ethylhexyl acetate
- Cas Number:
- 103-09-3
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 2-ethylhexyl acetate
- Details on test material:
- - Name of test material (as cited in study report): 2-Etylhexylacetat
- Physical state: Liquid / colorless-clear
- Analytical purity: 99.1 area%
- Lot/batch No.: TK149 v. 27.12.2002
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility .
- Storage condition of test material: Room temperature
- Other: pH value: ca. 6
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A ., 01540 Vonnas, France; SPF quality
- Age at study initiation: about 7 months
- Weight at study initiation: 3.86 - 4.31 kg
- Housing: single in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day )
- Water: tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the study
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:
- other: clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- maximum 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: flank, 2.5*2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol and Lutrol /water (1 : 1)
SCORING SYSTEM: OECD/Draize scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 2.11
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- other: erythema score was 2.33 in 2/3 animals; erythema in 2/3 animals and scaling (1/3) extending beyond the area of exposure; see table for details
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Any other information on results incl. tables
| Exposition: | 4 h | |||
| Animal | Reading | Erythema | Edema | Symptoms |
| 1 | 1 h | 2 | 0 | erythema extending beyond the area of exposure |
| 2 | 1 h | 2 | 0 | erythema extending beyond the area of exposure |
| 3 | 1 h | 3 | 1 | erythema and oedema extending beyond the area of exposure |
| 1 | 24 h | 2 | 0 | erythema extending beyond the area of exposure |
| 2 | 24 h | 3 | 0 | erythema extending beyond the area of exposure |
| 3 | 24 h | 3 | 0 | erythema extending beyond the area of exposure |
| 1 | 48 h | 2 | 0 | erythema extending beyond the area of exposure |
| 2 | 48 h | 2 | 0 | erythema extending beyond the area of exposure |
| 3 | 48 h | 2 | 0 | erythema extending beyond the area of exposure |
| 1 | 72 h | 1 | 0 | erythema extending beyond the area of exposure |
| 2 | 72 h | 2 | 0 | erythema extending beyond the area of exposure |
| 3 | 72 h | 2 | 0 | erythema extending beyond the area of exposure |
| 1 | 7 d | 0 | 0 | erythema extending beyond the area of exposure |
| 2 | 7 d | 1 | 0 | |
| 3 | 7 d | 2 | 0 | erythema and scaling extending beyond the area of exposure |
| 2 | 14 d | 1 | 0 | |
| 3 | 14 d | 1 | 0 | erythema extending beyond the area of exposure |
| mean animal 1 | 24 - 72 h | 1.67 | 0.00 | |
| mean animal 2 | 24 - 72 h | 2.33 | 0.00 | |
| mean animal 3 | 24 - 72 h | 2.33 | 0.00 | |
| mean | 24 - 72 h | 2.11 | 0.00 |
Observation was discontinued after 7 days in animal 1 because the animal was free of findings.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
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