Registration Dossier
Registration Dossier
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EC number: 242-554-8 | CAS number: 18748-98-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-09-12 to 2001-10-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 406 (Skin Sensitisation)
- Version / remarks:
- Adopted July 17,1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Adopted July 30,1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- at the time of conducting this study a regulatory approved LLNA Guideline was not available.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH (Harlan)
- Sex:
- female
- Details on test animals and environmental conditions:
- Test Animals
- Strain: HsdPoc:DH (Harlan)
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Diet: ssniff Ms-H (V2233), ad libitum
- Water: tap water, ad libitum
- Acclimation oeriod: at least 5 days
- Housing: in groups of five animals in transparent macrolon cages (type V) on soft wood granulate in an air-conditioned room
- Randomisation: Computer generated algorithm, randomisation scheme 2001.0039
Environmental Conditions
- Temperature: 20 +/- 3 °C
- Relative humidity: 50 +/- 20%
- Photoperiod:12 hours light/dark cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0,5 mL undiluted test item
- Day(s)/duration:
- day 0, day 8 and day 15 for 6 h
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL undiluted test item
- Day(s)/duration:
- day 29 for 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals in the treated group
10 animals in the control group
3 animals in the group for determination of a primary non-irritant concentration - Details on study design:
- Main Study
1) Induction exposure
- Days of exposure: 1, 8 and 15
-Test group (20 animals): 0.5 mL test substance, occlusiv (2x2 cm cellulose patchand coverd with polyethylene film)
- Control group (10 animals): 0.5 mL sesame oil, occlusiv (2x2 cm cellulose patchand coverd with polyethylene film)
- Duration of exposure: 6 hours
2) Challenge exposure
- No. of exposures: 1
- Day(s) of challenge: 29
- Test group: 0.5 mL test substance, occlusiv (2x2 cm cellulose patchand coverd with polyethylene film), exposure: 6 h
- Evaluation (hours after challenge): approx.24 h and 48 h after removal of the patches - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde in polyethylene glycol 400
Results and discussion
- Positive control results:
- Positive control assay (report date: 2001.04-17):
the challange treatment was carried out with 25 % alpha-hexylcinnamaldehyde in polyethylene glycol 400. All animals (10) showed a positive skin reaction during the observation period.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, none of twenty animals of the treatment group showed a positive skin response after the challange procedure.
- Executive summary:
Testing for sensitizing properties of the test item was performed in female Guinea pigs according to the method of Buehler (OECD TG 406).Under thde condition of the present study, none of twenty animals of the treatment group showed a positive skin response after the challenge procedure. Based on the results of this study the test item showed no evidence for sensitizing properties.
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