Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
during 1989-10-11 to 1990-07-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive control (reliability check) reported
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The study sponsor has indicated that the test material was a silicone material with ca. 5% triacetoxymethylsilane.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa-Crédo, FRANCE
- Age at study initiation: young adult
- Weight at study initiation: 341-459 g
- Housing: 5 or 6 (same sex) per polystyrene cage with perforated flooring
- Diet: standard diet ad libitum
- Water : drinking water ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30-70
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: within the period 1989-10-11 to 1990-07-09

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
material described as solid plaques
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
material described as solid plaques
No. of animals per dose:
10 males, 10 females for test and control groups
Details on study design:
RANGE FINDING TESTS:
2 males, 2 females: 6h occluded exposure to neat solid material

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: n=20, test material (2cm x 2 cm) solid
- Control group: n=20, distilled water (0.5 ml)
- Site: left lateral abdominal
- Frequency of applications: 3 applications at weekly intervals
- Duration: 6h
- Concentrations: neat solid material

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after final induction application
- Exposure period: 6h
- Test groups: n=20, test material (2cm x 2 cm) solid
- Control group: n=20, test material (2cm x 2 cm) solid
- Site: right posterior abdominal
- Concentrations: neat solid material
- Evaluation (hr after challenge): 24 and 48h

Challenge controls:
negative but not postitive controls included
Positive control substance(s):
no

Results and discussion

Positive control results:
no reliability check included

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
neat solid material
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: neat solid material. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
neat solid material
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: neat solid material. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A well conducted, well reported guinea-pig skin sensitization test (Buehler Method) found no evidence of sensitization potential when the 'neat' solid material was applied during the induction and challenge phases. No data were provided on the reliability of this test using a known sensitiser, as required in the guideline.