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EC number: 208-762-8
CAS number: 540-97-6
The key skin sensitisation study with dodecamethylcyclohexasiloxane
(D6), conducted according to OECD Test Guideline 406 and in compliance
with GLP, concluded that D6 was not sensitising to skin (NOTOX, 1999e).
Table 1: Incidence
of dermal response to challenge dosing
INTERVAL (AFTER 6h CHALLENGE)
SKIN REACTIONS NUMBERS OF ANIMALS (SCORE)
Challenge – test group
Vehicle (corn oil)
Challenge – control group
Re-challenge – test group
Re-challenge – control group
Positive control (alpha-cinnamic aldehyde)*
10% in water
* The control group
of 5 animals for the positive control test produced the following
reactions at 24, 48 and 72 h: 4(1), 3(1), 1(1).
regarding sensitization could be drawn from the first challenge
which produced responses in both the control and test group that
were believed to indicate an irritation response. There was no
indication of sensitization from the second challenge.
The key skin sensitisation study with dodecamethylcyclohexasiloxane (D6)
was conducted according to OECD Test Guideline 406 and in compliance
with GLP (NOTOX, 1999e).
At induction, the undiluted test material was applied intradermally and
epidermally to 10 guinea pigs. The intradermal induction on study day 0
was followed by an epidermal induction on study day 7. 24 Hours before
topical induction 10% sodium dodecyl sulfate was applied onto the skin
to induce mild inflammation. The control group of 5 animals was treated
similarly, but with the vehicle corn oil alone. Two weeks following the
epidermal application, all animals were challenged with the undiluted
test substance and the vehicle. A second challenge was performed one
week later with 50% and 20% test substance concentrations.
Following the first challenge, grade 1 skin reactions were observed in
three test and one control animals. No conclusion on the skin
sensitisation potential of the test substance could be drawn from the
first challenge results since comparable reactions were observed at the
test and control animals. In the second challenge, no skin reactions
were evident after the challenge exposure in the experimental animals to
the 50% and 20% test substance concentration. Based on the results from
the second challenge, D6 was concluded to be not sensitising to skin.
The positive control substance was alpha hexylcinnamic aldehyde (10%
aqueous) and gave the expected results.
Based on the reliable in vivo data, D6 does not require
classification for skin sensitisation according to Regulation (EC) No.
No data are available regarding respiratory sensitisation.
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