Registration Dossier
Registration Dossier
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EC number: 500-322-6 | CAS number: 144086-03-3 1 - 6.5 moles ethoxylated
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: 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerol, ethoxylated, esters with acrylic acid
- EC Number:
- 500-322-6
- EC Name:
- Glycerol, ethoxylated, esters with acrylic acid
- Cas Number:
- 144086-03-3
- Molecular formula:
- UVCB substance
- IUPAC Name:
- Glycerol, ethoxylated, esters with acrylic acid
- Details on test material:
- - Name of test material (as cited in study report): Glycerin3EOTA
- Physical state: Liquid / beige, turbid
- Analytical purity: >99%
- Lot/batch No.: GK0561/160
- 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 ca. 5
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., France
- Age at study initiation: 8 - 9 months
- Weight at study initiation: 3.72 kg - 3.93 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordieat (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kuiba SA, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum): Tap water
- Acclimation period: at least 5 days
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)
- 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:
- up to 72 h after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsolateral part of the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrole and Lutrole/ water (1 :1).
SCORING SYSTEM: Draize scores
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Score 2 was observed both, directly after patch removal and one hour thereafter
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Score 2 was observed both, directly after patch removal and one hour thereafter
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Score 2 was observed directly after patch removal and Score 1 one hour thereafter
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
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