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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
EC Number:
220-780-8
EC Name:
[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane
Cas Number:
2897-60-1
Molecular formula:
C11H24O4Si
IUPAC Name:
diethoxy(methyl){3-[(oxiran-2-yl)methoxy]propyl}silane
Constituent 2
Reference substance name:
[3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane
IUPAC Name:
[3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: B&K Universal Ltd., Hull, Uk
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: individually housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20
- Humidity (%):30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
undiluted
25% or 50% v/v in acetone/olive oil 4:1
No. of animals per dose:
16 females
Details on study design:
The mice were treated by application of 25 microlitres of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (days 0, 1, 2). A further group of 4 mice received the vehicle alone in the same manner.

Five days following the first topical application of the test material (day 5) all mice were injected via the tail vein with 250 microlitres of phosphate buffered saline containing a radiolabel. Five hours after that, all mice were killed. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group.

The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node, relative to that recorded for control nodes.
If a threefold increase compared to control values was recorded, the substance was considered a sensitiser.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
> 3
Test group / Remarks:
50% v/v
Key result
Parameter:
SI
Value:
> 3
Test group / Remarks:
100% v/v
Key result
Parameter:
SI
Value:
3
Test group / Remarks:
25% v/v
Remarks on result:
other: A stimulation index of <3 was recorded for the lowest concentration of the test material (25% v/v)
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: See "Remarks"
Remarks:
Vehicle 8425.12 Dpm, 1053.1 Dpm/node 25% 7802.73 Dpm 975.3 Dpm/node (negative) 50% 30366.88 Dpm 3795.8 Dpm/node (positive) 100% 39088.36 Dpm 4886 Dpm/node (positive)

Any other information on results incl. tables

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the study.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test material was considered to be a sensitiser under the conditions of the test. A stimulation index of >3 was recorded for the two higher concentrations of test material (50% v/v and 100%), relative to the negative controls.