Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August to November 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
An LLNA study was not performed because the 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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Clr: HA
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 4 weeks
- Weight at study initiation: 302 - 347 g
- Housing: Terluran cages on Altromin saw fibre bedding
- Diet: Altromin 3122 maintenance diet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 33 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12:12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: suspended in acetone
Concentration / amount:
Preliminary test to evaluate the irritation threshold:
2 animals treated with concentrations of 100% or 50% of the test item suspended in acetone for 6 hours.
2 animals treated with a concentration of 75% of the test item suspended in acetone for 6 hours.
Induction phases I, II and III: a concentration of 100% of the test item suspended in acetone for 6 hours. The phases were at weekly intervals.
Challenge phase: a concentration of 50% of the test item suspended in acetone for 6 hours.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: suspended in acetone
Concentration / amount:
Preliminary test to evaluate the irritation threshold:
2 animals treated with concentrations of 100% or 50% of the test item suspended in acetone for 6 hours.
2 animals treated with a concentration of 75% of the test item suspended in acetone for 6 hours.
Induction phases I, II and III: a concentration of 100% of the test item suspended in acetone for 6 hours. The phases were at weekly intervals.
Challenge phase: a concentration of 50% of the test item suspended in acetone for 6 hours.
No. of animals per dose:
4 animals in preliminary test, 20 animals in induction and challenge.
Details on study design:
RANGE FINDING TESTS:
2 animals were treated topically with 50% applied to right flank and 100% applied to left flank for 6 hours; 2 animals were treated topically with 75% applied to right and left flank for 6 hours. Irritation was evaluated.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: weekly
- Duration: weekly exposures for 3 weeks; challenge phase was initiated 14 days after the final induction.
- Concentrations: 50%

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Exposure period: six hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hours after removal of patch.
Challenge controls:
A reliability check was performed in May/June 2014. 20 animals were treated with 50% of the positive control substance in Vaseline in induction phases I, II and III; 20 animals were treated with 25% of the positive control substance in Vaseline in the challenge phase.
Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole, purity >98%

Results and discussion

Positive control results:
50% and 55% of the animals treated in the laboratory reliability check showed positive reactions at the 24 and 48 hour observations, respectively.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% suspension in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% suspension in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

Preliminary test: erythema grade 1 was observed at site of application in both animals treated for 6 hours with 100% test substance and both animals treated for 6 hours with 75% test substance. No erythema was observed in any animal at 48 and 72 hours. A concentration of 50% was found to be highest dose which did not cause any signs of irritation after 6 hours topical treatment and was chosen for the challenge application in the main test.

Induction: no sign of irritation was observed in any animal immediately after removal of patch. Erythema grade 1 was observed in 5/20 animals at Induction I, in 2/20 in induction II and 2/20 in induction III.

Challenge: neither erythema nor oedema was observed in any animal at any time of observation. There was no evidence of sensitisation and the percentage of sensitised animals was 0%.

Body weight: body weights were within the range of variation of this strain.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
[2-(perfluorohexyl)ethyl]trimethoxysilane has been tested in a guinea-pig maximisation (Buehler) study conducted according to OECD 406 and in compliance with GLP. None of the animals challenged for 6 hours to the test item or the negative control showed any evidence of sensitisation at either 24 or 48 hours after removing the patch.