Registration Dossier
Registration Dossier
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EC number: 947-850-7 | CAS number: -
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in May 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(1-oxooctadecyl)sarcosine
- EC Number:
- 205-539-7
- EC Name:
- N-(1-oxooctadecyl)sarcosine
- Cas Number:
- 142-48-3
- Molecular formula:
- C21H41NO3
- IUPAC Name:
- N-methyl-N-stearoylglycine
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino of the stock Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Age at study initiation: approx. 20-21 months
- Weight at study initiation: 2.7-2.9 kg
- Housing: animals were caged individually in PPO caged with perforated floor
- Diet: pelleted complete rabbit diet “Altromin 2123”, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h (confirmatory test)
- Observation period:
- 14 days
Reading time points: 1, 24, 48, and 72 h and 7 and 14 days - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: anterior right field of the back of each rabbit
- Type of wrap if used: 16- layer gauze patch (2.5 x 2.5 cm) secured semi-occlusively with adhesive Gothaplast tape (2.5 cm wide) and fixed with Gothaplast tape (5 cm wide) loosely wound around the trunk of the animals.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin was cleaned with mild soap and lukewarm water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize score system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One animal used in the initial test, showed a well-defined erythema and a very slight edema on the posterior right test field immediately after the application.
1 h after the termination of exposure a well-defined erythema and a very slight edema were noted on the posterior right test field of the same animal. Two further animals displayed a very slight erythema on the anterior right test field.
24, 48 and 72 h after the termination of exposure a well-defined erythema was observed on the posterior right test field of the first animal. A second animal showed a very slight erythema on the anterior right test field, whereas a well-defined erythema was observed on the anterior right test field of the third animal.
7 days after the termination of the application the first animal showed large scales in a middle-grade on the whole posterior right test field. Slight scurf was observed on the anterior right test field of the second and third animals.
14 days after the termination of application the first animal showed slight scurf on then whole posterior right test field. Isolated scales were observed on the anterior right test field of the second animal, whereas the third animal was free of any signs of skin irritation.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irrit. 2, H315. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
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