Registration Dossier
Registration Dossier
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EC number: 209-097-6 | CAS number: 555-43-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Dec -05 Dec 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test material
- Reference substance name:
- Glycerol tristearate
- EC Number:
- 209-097-6
- EC Name:
- Glycerol tristearate
- Cas Number:
- 555-43-1
- Molecular formula:
- C57H110O6
- IUPAC Name:
- 1,3-bis(octadecanoyloxy)propan-2-yl octadecanoate
- Details on test material:
- - Name of test material (as cited in study report): Glycerol tristearate, ([trade name])
- Physical state: white, homogeneous powder
- Analytical purity: 98%
- Purity test date: June 17th, 1996
- Batch No.: 512014
- Date of production: January 29th, 1996
- Stability under test conditions: > 3 years
- Storage condition of test material: in tightly closed containers under exhaust hood, kept dry
- Solubility (20 °C): practically insoluble in water
- Density (20°C): about 0.95 g/cm³
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White New Zealand albino, HsdPoc:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: adult animals
- Weight at study initiation: 2.3, 2.7 and 2.6 kg (animals #1, 2 and 3, respectively)
- Housing: conventional, single housing in stainless steel cages
- Diet: Ssniff K 4 complete feed for rabbits (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with demineralised water
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: The grinded powdery test substance was moistened with 0.5 mL demineralised water. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 30-60 min, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm² on the dorsal area of the trunk
- Type of wrap if used: the treated skin was covered with a gauze patch which was secured in place with a non-irritant plaster. The patch was held in contact with the skin using a suitable semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin area was washed with warm water to remove residual test substance.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 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
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 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:
- No skin reactions were observed in any animal at any reading time point.
- Other effects:
- No further local or systemic effects were reported.
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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