Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18.11.1997 to 25.06.1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 GmnH
- Age at study initiation: 'young'
- Weight at study initiation: <500 g
- Housing: Maximum five animals in conventional Type IV Makrolon cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: Preliminary study: from: 18.11.1997 to 21.11.1997. Main study: from: 26.05.1998 to 25.06.1998

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction and challenge phases: undiluted test substance.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction and challenge phases: undiluted test substance.
No. of animals per dose:
20 test animals, 10 control.
Details on study design:
RANGE FINDING TESTS: 0.3cm3 of each of the test substance concentrations 5, 25, 50% (in corn oil) and undiluted test substance were applied to patches of surgical gauze. These were placed on the clipped flanks of each of three animals. The patches were covered with occlusive plaster and left in place for six hours. Each animal recieved two patches on each flank. After removal of the patch, residual test substance was cleared away using corn oil The dermal reactions were assessed 30 and 54 hours after the start of treatment. In the 4th week of the test, three guinea-pigs,kept under the same conditions, but without treatment, were used to re-determine the maximum non-irritant concentration for the challenge treatment. This additional determination was conducted because it was suspected that the sensitivity of the skin changed as the weight of the animals increased. In this test, the concentration administered and the experimental conditions were the same as those of the preliminary test.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Six hours
- Test groups: Undiluted test substance
- Control group: Corn oil only
- Site: Left flank
- Frequency of applications: Weekly
- Duration: 28 days from first induction to challenge exposure
- Concentrations: Undiluted test substance


B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 28
- Exposure period: Six hours
- Test groups: Undiluted test substance
- Control group: Corn oil only
- Site: Right flank
- Concentrations: Undiluted test substance
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches.
Challenge controls:
Corn oil
Positive control substance(s):
no

Results and discussion

Positive control results:
No positive control.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted test substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No significant treatment-related observations.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted test substance . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No significant treatment-related observations. .
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No significant treatment-related observations.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: undiluted corn oil . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No significant treatment-related observations. .

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a well conducted skin sensitisation study conducted to OECD 406 (Buehler method) and GLP (reliability score 1) tetramethylsilane was not sensitising to the skin of guinea-pigs.
Executive summary:

In a well conducted skin sensitisation study conducted to OECD 406 (Buehler method) and GLP (reliability score 1) tetramethylsilane was not sensitising to the skin of guinea-pigs.