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EC number: 250-418-4
CAS number: 30989-05-0
The derived skin sensitisation effects from
the key study was:
No sensitising effects observed, according to OECD 406, Shell, 1990;
B-TEGME is considered not to be sensitising
for skin based upon systematic negative findings in various Magnussen
and Kligman sensitisation tests with brake fluids. Sensitisation was
tested by epidermal and topical induction, followed by topical challenge
under occlusion in guinea-pigs.
Table 1: Response after intradermal
induction (dose range finding)
n – slight necrosis at
Table 2: Response after topical
induction (dose range finding)
Table 3: Response after
intradermal/topical induction & topical challenge (main study)
Body weight (g)
Response to challenge at time
Brake fluid DOT 4 Super (containing 37% B-TEGME) was
tested for sensitization in the guinea-pig maximization test of
Magnussen and Kligman and according to the OECD 406. In a dose range
finding test in 2 male and 2 female guinea-pigs/group, 0.1 ml (0.6% in
water) and 0.3 ml (undiluted test material) showed slight irritancy and
were therefore selected for intradermal and topical induction for 48h,
respectively. For challenge, 60% test material (equivalent to 22%
B-TEGME) in water was applied under occlusive tape for 24h.
None of the 10 male and 10 female test animals showed a
positive response 24 or 48 hours after removal of the challenge patches.
None of the 5 male and 5 female control animals showed any response to
application of the 60% (equivalent to 22% B-TEGME) test material in
It can be occluded that B-TEGME is not sensitizing to the skin.
No sensitisation was observed in three studies with Brake fluids containing B-TEGME according to the guinea-pig maximization test, which is accepted as a relevant method. Although no studies were available with pure B-TEGME, 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-TEGME would be a sensitizer in man.
The key study for skin sensitisation was performed with a brake fluid containing 37% B-TEGME, which was tested in the guinea-pig maximization test of Magnussen and Kligman (Shell, SBGR 90.189, 1990). 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-TEGME containing brake fluid was not sensitizing, it is unlikely that B-TEGME 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 50% dilution of test material in water for challenge (Shell, TLGR.0090.77, 1977). 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, TLGR.0015.75, 1975). No reactions for sensitisation or irriation were observed in both studies in tested and control animals.
The available experimental test data are
reliable and suitable for classification purposes under Regulation
1272/2008. As a result, the substance is not considered to be classified
for skin sensitisation under Regulation (EC) No. 1272/2008.
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