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EC number: 310-290-3
CAS number: 161907-80-8
The sensitisation potential of B-TTEGME was studied by read-across
with data from various test materials, including Brake Fluid DOT4 Super
and Brake Fluid DOT 4. Similarity with B-TTEGME was based on a common
functional group, common precursors an/or likelihood of common breakdown
products and common constituents, as also described in a separated
justification document in Section 13.
No sensitisation was observed in three studies with brake fluids
containing B-TTEGME according to the guinea-pig maximization test, which
is accepted as a relevant method. Although no studies were available
with pure B-TTEGME, the studies were performed according to
international accepted testing guidelines with appropriate
concentrations that were based upon preliminary testing. The studies
were consistent in approach and results, and were therefore considered
to be adequate and reliable. Since this technique has been shown to
detect substances of weak skin sensitizing potential, it is unlikely
that B-TTEGME would be a sensitizer in man.
The key study for skin sensitisation was performed with a brake
fluid containing 76% B-TTEGME of which 45% was B-TEGME, corresponding
with 37% B-TEGME. The test material was tested in the guinea-pig
maximization test of Magnussen and Kligman (Shell, 1990c). In a dose
range finding test in 2 male and 2 female guinea-pigs/group, 0.6% in
water and undiluted test material were selected for intradermal and
topical induction, respectively. For challenge, 60% test material in
water was applied under occlusive tape for 24h . None of the animals
showed a positive response at 24 and 48 hours after removal of the
challenge patches. The study was conducted according to the guinea-pig
maximization test, which is accepted as an older but relevant method.
Since this Magnussen and Kligman technique has been shown to detect
substances of weak skin sensitizing potential and the B-TTEGME
containing brake fluid was not sensitizing, it is unlikely that B-TTEGME
would be a sensitizer in man.
Secondly, brake fluid was also negative for skin sensitisation in
10 male and & 10 female guinea-pigs according to the guinea-pig
maximization procedure, with 5% dilution in water for intradermal
induction and undiluted test material for topical induction, followed by
60% dilution of test material in water for challenge (Shell, 1977e). In
another study with Brake fluid 500 DOT 4 there was also no skin
sensitisation with 1% w/v dilution in corn oil and undiluted test
material for topical induction and challenge (Shell, 1975d). No
reactions for sensitisation or irritation were observed in both studies
in tested and control animals. These studies were considered to be
supportive to demonstrate the absence of sensitising potential of
Brake fluids containing up to 76% B-TTEGME (and up to 38% B-TEGME)
did not cause sensitisation. Classification for B-TTEGME as sensitizer
is not warranted.
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