Registration Dossier
Registration Dossier
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EC number: 203-846-0 | CAS number: 111-21-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 08 May - 18 May 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
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)
- Version / remarks:
- adopted in 1981
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethyl acetate
- EC Number:
- 203-940-1
- EC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Cas Number:
- 112-15-2
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Ethyldiglykolacetat
- Physical state: liquid
- Analytical purity: 99.8%
- Density: 1.01 g/cm³
- Storage conditions: inert gas atmosphere, dry
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Small White Russian (Chbb-SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.7 kg
- Housing: individually in stainless steel cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, Soest, Germany; ad libitum
- Water: tap water; ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated sites served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL on an approx. 6 cm² area of the skin - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days
Reading time points: 1, 24, 48, and 72 h and 6, 8, and 10 days after application - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Test site preparation: Approx. 24 h before application, the dorsal and lateral parts of the trunk were clipped (10 x 10 cm).
- Area of exposure: approx. 6 cm² (2.5 x 2.5 cm)
- Type of wrap if used: gauze patch fixed with an elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, substance residues were washed off softly with warm water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Only very slight effects (max. score = 1) were observed throughout the study. No edema were seen with the exception of animal #1 at the 1-hour reading. Slight erythema were seen in two animals 1 hour after application which were fully reversible within 72 h and 8 days, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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