Registration Dossier
Registration Dossier
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EC number: 242-554-8 | CAS number: 18748-98-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-09-18 to 2001-09-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- at the time of conducting this study a regulatory approved in vitro study was not available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted July 17, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted July 31, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trimethyl(octadecyloxy)silane
- EC Number:
- 242-554-8
- EC Name:
- Trimethyl(octadecyloxy)silane
- Cas Number:
- 18748-98-6
- Molecular formula:
- C21H46OSi
- IUPAC Name:
- trimethyl(octadecyloxy)silane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test Animals
- Strain: Crl:KBL(NZW)BR (N.Zeal.White)
- Source: Cherles River GmbH, Kißlegg, Germany
- Diet: ssniff K-H (V2333), ad libitum and hay
- Water: tap water, ad libitum
- Body weight at start of the study: 3.27-3.79 Kg
- Acclimation oeriod: 1 week under study conditions
- Housing: in fully air-conditioned rooms in seperate cages arranged in a battery
Environmental Conditions
- Temperature: 20 +/- 3 °C
- Relative humidity: 50 +/- 20%
- Photoperiod:12 hours light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Test material:
0.5 mL test item - Duration of treatment / exposure:
- one administration 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: approximately 2.5 x 2.5 cm
- Exposure: 0.5 mL test item, semi-occlusive, 4 hours
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with warm tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: as in OECD TG 404 described, reading at 1, 24, 48 and 72 h after removal of test item.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
To assess the skin irritation potential of the test item an in vivo skin irritation test in New Zealand White rabbits was performed regarding to OECD TG 404. Based on the result of this study the test item is not irritating to skin according to th eclassification criteria of Directive 93/21/EEC.
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