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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-01-03 until 1997-04-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Silane CP 2
- Physical state: liquid
- Analytical purity: 96.3% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 10466 QB
- Expiration date of the lot/batch: 1997-12-01
- Stability under test conditions: stable in corn oil; unknown in Freud's Complete adjuvant
- Storage condition of test material: in original container, at room temperature, in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: main test: 339 - 373 (control and test group)
- Housing: standard laboratory conditions
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: main test: one week under test conditions after health examination


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Test group
Intradermal induction: 5% dilution of the test substance in corn oil and in an emulsion with Freund's Complete Adjuvant
Epicutaneous induction: 25% dilution of test substance in corn oil
Epicutaneous challenge 15% dilution of the test substance in corn oil
Control Group
Animals were induced with corn oil and Freund's Complete Adjuvant and challenged similarly as those of the test group
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Test group
Intradermal induction: 5% dilution of the test substance in corn oil and in an emulsion with Freund's Complete Adjuvant
Epicutaneous induction: 25% dilution of test substance in corn oil
Epicutaneous challenge 15% dilution of the test substance in corn oil
Control Group
Animals were induced with corn oil and Freund's Complete Adjuvant and challenged similarly as those of the test group
No. of animals per dose:
Test group: 10
Control: 5
Intradermal pretest: 1
Epidermal pretest: 2
Details on study design:
RANGE FINDING TESTS:
Intradermal: 5, 3 and 1% of test article in corn oil - 5% test substance solution was selected for main test.
Epidermal: 75%, 50%, 25% and 15% of test substance in corn oil - Concentration selected for the induction period and challenge procedure was 25% and 15% test substance in corn oil, respectively.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal exposure on test day 1; epidermal exposure on test day 8
- Exposure period: 8 days
- Test groups: one test group
- Control group: one control group (corn oil)
- Site: scapular region


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: test day 22
- Exposure period: 24 hours
- Test group: 15% test substance in corn oil
- Control group: 15% test substance in corn oil
- Site: left and right flank
- Evaluation (hr after challenge): 24 and 48 hours


Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde

Results and discussion

Positive control results:
In this study 70% of the animals of the test group were observed with positive skin reactions after treatment with an non-irritant test substance concentration of 25% in polyethylene glycol. No skin reactions were observed in the control group.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
15% test substance in corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical signs. One animal was found dead on test day 12.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 15% test substance in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs. One animal was found dead on test day 12..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
15% test substance in corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical signs has been observed. One animal was found dead on test day 12.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 15% test substance in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs has been observed. One animal was found dead on test day 12..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No clinical signs were observed. One animal was found dead on test day 9.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No clinical signs were observed. One animal was found dead on test day 9..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No clinical signs have been observed. One animal was found dead on test day 9.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No clinical signs have been observed. One animal was found dead on test day 9..

Applicant's summary and conclusion

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

In order to assess the cutaneous allergenic potential of Silane CP 2, the maximization test in accordance with OECD Guideline 406 was carried out on 15 (10 test and 5 control) male albino guinea pigs. Maximally tolerated concentrations of the test substance suitable for the induction phase of the main study and a suitable non-irritant concentration of the test substance, by the topical route of administration , for the challenge application have been defined based on pretest results.

In this study 0% of the animals of the test group were observed with positive skin reactions after treatment with an non-irritant test substance concentration in corn oil. No skin reaction were observed in the control group. Therefore, the test substance is considered to be not a skin sensitzer in this test.