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Toxicological information

Skin sensitisation

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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:
2001
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

Constituent 1
Chemical structure
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

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.