Registration Dossier
Registration Dossier
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EC number: 295-118-4 | CAS number: 91844-53-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 -22 Feb 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test material
- Reference substance name:
- Sorbitan, octanoate (2:3)
- EC Number:
- 295-118-4
- EC Name:
- Sorbitan, octanoate (2:3)
- Cas Number:
- 91844-53-0
- Molecular formula:
- Not available for UVCB
- IUPAC Name:
- Sorbitan, octanoate (2:3)
- Details on test material:
- - Name of test material (as cited in study report): Sorbitan-octanoate(2:3)
- Substance type: organic
- Physical state: ambner viscous liquid
- Analytical purity: 100 %
- Lot/batch No.: ES66941443
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kissleg, Germany
- Weight at study initiation: 1574.5 g and 1626.8 g (female), 1704.2 g (male)
- Housing: Single in steel cages with a plastic bottom mould and a habitat of 5,445 cm² at the bottom and an overall height of 600 mm. A non-barrier system with air conditioning was used.
- Diet: Food type “2023" from Altromin International, Lage, Germany as pelleted diet (Batch No.: 1105; expiry date: 2008-09-03), ad libitum.
- Water: Drinking water consisted of normal tap water from municipal source (SWK AQUA GmbH, Krefeld, Germany), ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3 °C
- Humidity (%): 30% - 70%
- Air changes (per hr): 8 times/h
- Photoperiod (hrs dark / hrs light): dimmed daylight, no further data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL at an area of approx. 6 cm² - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 2 female, 1 male
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Coverage with a gauze pad (Askina® Brauncel, B. Braun Petzold GmbH, Melsungen, Germany) which was held in place by strips of Micropore (3M company, St. Paul, USA).
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed by washing with warm soapy water and the application areas were examined.
- Time after start of exposure: 4 h
SCORING SYSTEM: Scoring according to guideline
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 erythema and oedema and no other dermal response were observed at any time point after application of the test substance.
Any other information on results incl. tables
Symptoms of systemic toxicity caused by the test substance were not observed during the whole study.
Body weight gain was positive and within normal range.
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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