Registration Dossier
Registration Dossier
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EC number: 292-947-3 | CAS number: 91031-45-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Feb - 01 Mar 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 0.4 g instead of 0.5 g of the test substance were applied.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 0.4 g instead of 0.5 g of the test substance were applied.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters
- EC Number:
- 292-947-3
- EC Name:
- Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters
- Cas Number:
- 91031-45-7
- Molecular formula:
- C38-42H74-82O6
- IUPAC Name:
- Fatty acids, C16-18 (even-numbered), 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Chemical denomination: Fatty acid, C16-18, 1,2-Ethandiyl Bis (Oxy-2,1-Ethandiyl) ester
- Substance type: pure substance
- Physical state: white solid
- Analytical purity: 100%
- Lot/batch No.: 051031017
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: 25 months
- Weight at study initiation: mean 2840 g
- Housing: single holding in cage
- Diet: Altromin-Haltungsdiät 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with a gauze-patch and an adhesive air- and vapor-permeable patch, held in place with hypoallergenic adhesive gauze-bandage.
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 during the study period.
- 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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