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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:
2002-06-19 until 2002-08-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method already available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Silane 434106 VP
- Substance type: intermediate
- Physical state: liquid
- Stability under test conditions: pure: stable until 2003-12-31
in Water: hydrolysis in water
- Storage condition of test material: room temperature in the dark

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, D-33178 Borchen
- Weight at study initiation: 300-500 g
- Housing: semi-barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least ^10
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
cotton seed oil
Challenge
Route:
epicutaneous, occlusive
Vehicle:
cotton seed oil
No. of animals per dose:
10 in main study
Details on study design:
RANGE FINDING TESTS:
3 Animals were intradermally treated with 1% and 5% concentration of the test items. Signs of erythema and necrosis (size approx. 0.5 cm) were recorded 24 h, 48 h, and 72 h after application of the 5% concentration. For the 1% concentration only slioght signs of erythema were found at the 24 h and 48 h readings. 2 Animals were topically treated with 50% as well as 100 % for 24 and 48 h respectively. No signs of irritation and systemic toxicity were observed.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 7days
- Test groups: pure substance or TS 5% in Cotton seed oil
- Control group: cotton seed oil
- Site: shoulder region
- Frequency of applications: days 0, 6 and 7
- Duration: intradermally and dermally 48h occlusive
- Concentrations: 1% in cotton seed oil (first stage); pure (second stage)


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: beginning on day 20 for 3 days
- Exposure period: 24 h
- Test groups: pure substance
- Control group: cotton seed oil
- Site: shoulder region
- Concentrations: pure
- Evaluation (hr after challenge): 24, 48, and 72 h

Positive control substance(s):
yes
Remarks:
Mercaptobezothiazole, CAS number 149-30-4

Results and discussion

Positive control results:
The reliability control worked as expected (test report)

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
pure substance
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: test group. Dose level: pure substance. 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:
pure substance
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: test group. Dose level: pure substance. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
pure substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading:
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
-
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: -. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
-
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: -. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
-
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading:
Reading:
other: positive control
Group:
positive control
No. with + reactions:
3
Total no. in group:
3
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The substance is not sensitizing to the skin.
Executive summary:

A guinea pig maximization test on the test substance according to OECD 406 did not show any sensitizing effects when applied.