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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23.07.1984 to 27.08.1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.

Test material

Constituent 1
Chemical structure
Reference substance name:
Octamethylcyclotetrasiloxane
EC Number:
209-136-7
EC Name:
Octamethylcyclotetrasiloxane
Cas Number:
556-67-2
Molecular formula:
C8H24O4Si4
IUPAC Name:
2,2,4,4,6,6,8,8-octamethyl-1,3,5,7,2,4,6,8-tetroxatetrasilocane

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: no data; albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co KG, D-4799 Borchen
- Age at study initiation: No data (may have been missed in translation)
- Weight at study initiation: 425-555 g
- Housing: Groups of 3, 4 or 5 in Makrolon Type IV cages
- Diet (e.g. ad libitum): 8 kg/week for 120 animals
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 45%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 23.07.1984 To: 27.08.1984

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction: 100 and 1%
Challenge: 100 and 10%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction: 100 and 1%
Challenge: 100 and 10%
No. of animals per dose:
20 test group
10 negative control
Details on study design:
RANGE FINDING TESTS: Four formulations per animal (12.5, 25, 50 and 100%) were occlusively applied to the shaved flank skin (24 hours, each area approximately 2.5x2.5 cm). No further details could be translated.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two
- Exposure period: 48 hours
- Test groups: 1% intradermally (100% in 2nd induction epicutaneously) D4 in paraffin oil, 1% (100% in 2nd induction) D4 in FCA (50% in paraffin oil)
- Control group: FCA alone, paraffin oil alone, and paraffin oil with FCA
- Site: Flank
- Frequency of applications: Weekly

B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 28
- Exposure period: 24 hours
- Test and control groups: 100 and 10 % D4 in paraffin oil
- Site: Flank
- Concentrations: 100 and 10%
- Evaluation (hr after challenge): 48, 72 and 96
Challenge controls:
FCA in vehicle and vehicle alone.
Positive control substance(s):
no

Results and discussion

Positive control results:
There was no positive control in this study.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10% or 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
other: There was no positive control in this study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a guinea-pig maximisation test (GMPT) conducted to OECD 406 and GLP (reliability score 1), D4 was not sensitising to the skin.

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