Registration Dossier
Registration Dossier
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EC number: 257-473-3 | CAS number: 51851-37-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10th March 1997 to 14th March 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [2-(Perfluorohexyl)ethyl]triethoxysilane
- IUPAC Name:
- [2-(Perfluorohexyl)ethyl]triethoxysilane
- Reference substance name:
- Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
- EC Number:
- 257-473-3
- EC Name:
- Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
- Cas Number:
- 51851-37-7
- Molecular formula:
- C14H19F13O3Si
- IUPAC Name:
- triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: small white Russian Mol:Russian / Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Breeding/Research Centre Ltd., Tornbjergvej 40, Ejby DK-4623 LI. Skensved, Denmark
- Age at study initiation: no information
- Weight at study initiation: 2.3, 2.3 and 2.4 kg
- Housing: conventional, single animal per stainless steel cage.
- Diet: Ssniff K4 complete diet for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Four hours
- Observation period:
- 30-60 minutes, 24, 48 and 72 hours, and 6 days after removal of the patch.
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze covered with a non-irritating bandage and then a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water
- Time after start of exposure: four 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:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- <= 1
- Max. score:
- 4
- Remarks on result:
- other: very slight edema was observed at 48 and 72 hours after patch removal
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- [2-(perfluorohexyl)ethyl]triethoxysilane has been tested for acute skin irritation in a semi-occlusive study conducted according to OECD TG 404 and in compliance with GLP. Very slight erythema was observed after 30-60 minutes, and 2, 48 and 72 hours, in two of the three small white Russian rabbits exposed to the undiluted test substance for four hours. One animal showed very slight edema 48 and 72 hours after the removal of the bandage. All signs of irritation had reversed by 6 days after application. One animal showed no signs of skin irritation during the entire observation period. It is concluded that the test substance is not irritating to the skin.
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