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EC number: 257-473-3 | CAS number: 51851-37-7
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Pretest: 1997-04-06 to 1997-04-09; main test: 1997-04-15 to 1997-05-16
- 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 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler/Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstraße 27, 33176 Borchen
- Age at study initiation: no information
- Weight at study initiation: less than 50 g
- Housing: conventional, maximum of 5 animals per Macrolon cage - Type IV. Bedding: softwood shavings.
- Diet: Ssniff G4, complete diet for guinea pigs ad libitum
- Water: tap water ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: To: 16 May 1997
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Pretest: 5, 25% and 50% solutions in corn oil, and undiluted; induction: undiluted; challenge: 50%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Pretest: 5, 25% and 50% solutions in corn oil, and undiluted; induction: undiluted; challenge: 50%
- No. of animals per dose:
- Three
- Details on study design:
- RANGE FINDING TESTS: 0.03 cm² of test substance was applied as 5%, 25% and 50% solutions in corn oil and in undiluted form to gauze pads (2 x 2 cm) which were applied to flank skin which had been shaved 2-3 hours earlier. Each pad was covered with an occlusive bandage and then another bandage for six hours. Each of the three animals had two gauze pads on each side. After removal of the patch the application sites were wiped with corn oil and cellulose. Dermal reactions were evaluated 30 and 54 hours after application. In the fourth week of the test, 3 additional untreated guinea pigs were used to determine the maximum, non-irritant concentration to be used in the challenge treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: six hours at weekly intervals (day 0, day 7 and day 14).
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: weekly
- Concentrations: 100% test substance
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 28
- Exposure period: six hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank
- Concentrations: 50% test substance
- Evaluation (hr after challenge): 30 and 54 hours after beginning of application - Challenge controls:
- The sensitivity of the guinea pig breed used for the sensitisation test was monitored in regularly established time intervals; the last sensitivity test was carried out from 25 November to 20 December 1996 using the Magnusson-Kligman maximisation test using adjuvant.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
- Positive control results:
- 100% of the ten test animals showed a sensitisation reaction at 48 and 72 hours after challenge. None of the control animals showed evidence of sensitisation.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: Evaluation 30 hours after induction phases I, II and III, and 30 h and 54 hours after challenge
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No systemic effects or effects on normal body weight development were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Evaluation 30 hours after induction phases I, II and III, and 30 h and 54 hours after challenge
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: evaluation of the trigger treatment (50%) was done at 48 and 72 hours after induction with 1.0% 2-Mercaptobenzothiazole in corn oil via intracutaneous injection
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema and scale formation, swelling. Control group (n=5): no reaction
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Test conducted 25 Nov. to 20 Dec. 1996
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin sensitisation study, conducted according to an appropriate OECD test guideline 406, and in compliance with GLP, the test substance, [2-(perfluorohexyl)ethyl]triethoxysilane, was reported to be not sensitising to guinea pig skin.
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