Registration Dossier
Registration Dossier
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EC number: 233-226-5 | CAS number: 10094-45-8
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:
- guideline study
- Remarks:
- GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
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:
- N-octadecylstearamide
- EC Number:
- 236-276-6
- EC Name:
- N-octadecylstearamide
- Cas Number:
- 13276-08-9
- Molecular formula:
- C36H73NO
- IUPAC Name:
- N-octadecyloctadecanamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 13-15 weeks
- Weight at study initiation: 2.56-3.08 kg
- Housing: Individually in plastic cages with perforated floors.
- Diet: Standard laboratory animal diet LK-01, pellet diameter 4 mm (Hope Farms, Woerden, The Netherlands), 100 g per day.
- Water: Tap-water, ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-22.0
- Humidity (%): 60-80
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: contralateral flank served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Test substance preparation: Approximately 5 g of test substance were scraped from the surface of the solid and transferred into a glass vial; before dose administration the test substance was heated to 80-90 °C, and 3 portions of 0.5 mL were transferred into aluminium vials using a glass syringe. The portions of test substance were allowed to solidify in the vials. Each portion of test substance was spread on a 6 cm² patch of Metalline and applied to the animals as described below.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL for moistening - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of clipped area of 10 cm x 10 cm on the central back (right flank).
- Type of wrap if used: Test substance was spread on a 6 cm² patch of Metalline (Lohmann, FRG), mounted on permeable tape (Micropore, 3M, St. Paul, USA). Each portion of test substance was moistened with 0.5 mL of Milli-RO water (Millipore Corp., Bedford, Mass. USA). The patch containing the test substance was applied to the right flank of each animal, the left flank being covered with the same dressing without test substance. Finally, the animals were wrapped in flexible bandage (Coban, 3M, St. Paul, USA).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, remaining test substance was removed, using a tissue moistened with tap-water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- The skin of all three animals did not show any reactions at any observation timepoint.
- Other effects:
- There were no signs of systemic toxicity observed in any of the animals.
Any other information on results incl. tables
Conclusion:
According to the criteria of Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the skin.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
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