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Toxicological information

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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Skin sensitization, ASTM F-2147-01, HIMA document No. 10, Vol. 3, August 1981 and literature references
GLP compliance:
yes (incl. certificate)
Type of study:
split adjuvant test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Split adjuvant 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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,4,6,8-Tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane, supplied as Dow Corning Q4-2782

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS

- Age at study initiation: 4 weeks

Study design: in vivo (non-LLNA)

Induction
Route:
other: topical
Vehicle:
other: Dow Corning 200 fluid
Concentration / amount:
0.2 ml of 50% dilution in Dow Corning 200 fluid (vehicle), 10 cst for induction
0.1 ml of 15% dilution in Dow Corning 200 fluid (vehicle), 10 cst for challenge
Challenge
No.:
#1
Route:
other: topical
Vehicle:
other: Dow Corning 200 fluid
Concentration / amount:
0.2 ml of 50% dilution in Dow Corning 200 fluid (vehicle), 10 cst for induction
0.1 ml of 15% dilution in Dow Corning 200 fluid (vehicle), 10 cst for challenge
No. of animals per dose:
10 animals in vehicle (dow Corning 200 fluid, 10 cst)
20 animals in treatment group
Details on study design:
Four induction doses were applied over ten days to the same depilated site on guinea pigs, followed by occlusive patching for 48 hours. At the time of the third application , 0.2 ml of Freunds's Complete Adjuvant was injected to the induction test site. After a ten day rest period, the animals were challenged at a previously unexposed site and occlusive test patch system was held in contact with the skin for 24 hours.
Challenge controls:
At the challenge no skin reaction were observed in the control animals after treatment with test substance diluted to 15%.
Positive control substance(s):
yes
Remarks:
provided by personal communication by DCC: 0.1% 1-chloro-2,4-dinitrobenzene in acetone

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
15% dilution in vehicle
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
15% dilution in vehicle
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not sensitising in albino guinea pigs when tested under the conditions of the Split Adjuvant assay.
Executive summary:

No evidence of skin irritation or skin sensitization was observed in any of the animls following challenge phase. No skin reactions were present in the control group after treatment with vehicle. In the test group after the 4th induction 80% of animals elicited a response of 1 (very slight erythema) or greater (slight to moderate erythema) with mean erythema score of 1.40. At the challenge no skin reactions were observed in either the control or test animals after treatment with test substance diluted to 15%.