Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Feb - 16 Mar 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen
Type of study:
Buehler test
Justification for non-LLNA method:
The test was performed in 1995 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dimethoxydiphenylsilan
- Physical state: liquid

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, Versuchstierzucht, Gartenstraße 27, 33176 Borchen, Germany
- Weight at study initiation: < 500 g
- Housing: max. 5 animals/ Makrolon cage type IV, bedding Weichholzfaser Type HW300/500 W (Fa. JELU Werk, Ludwigsmühle, 73494 Rosenberg, Germany)
- Diet: Ssniff G4-Alleindiät für Meerschweinchen (Fa. Ssniff, Spezialfutter GmbH, 59494 Soest, Germany), ad libitum
- Water: tab water ad libitum
- Acclimation period: at least 5 days

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

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
100% (v/v)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
100% (v/v)
No. of animals per dose:
main study
10 (controls), 20 (in test groups)

range finding study
3
Details on study design:
RANGE FINDING TESTS:
- Exposure period: 6 h
- Test groups: 3 animals
- Site: two occlusive patches (2 x 2 cm) on each flank
- Frequency of applications: single
- Dose: 0.3 ml
- Concentrations: 5, 25, 50 and 100% (v/v)
- Vehicle: maize oil

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (epicutaneous day 0, 7 and 14)
- Exposure period: 6 h
- Test groups: test substance 100% (v/v)
- Control group: maize oil
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Day 0-21
- Concentrations: 100% (v/v)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: test substance 100% (v/v) and vehicle only
- Control group: test substance 100% (v/v) and vehicle only
- Site: posterior right flank (test substance) and anterior right flank (vehicle)
- Concentrations: 100%
- Evaluation (hr after challenge): 30 and 54 h after patch removal

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

In a range finding study none of the applied dilutions, namely semiocclusive patcg of 0.3 mL of a 5, 25, 50 and 100% (v/v) solution in maize oil for 6 h, was irritating to the skin of the test animal. Therefore the pure test substance was used for both induction and challenge in the main study. Weight gain was normal in all animals. No clinical signs were observed.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The available data on skin sensitisation of the structural analogue dimethoxydiphenylsilane (CAS: 6843-66-9) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.