Ethanol, 2-methoxy-, manufacture of, by-products from, esters with boric acid

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

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 B-TTEGME.

Migrated from Short description of key information:
B-TTEGME is considered not to be sensitising for skin based upon negative findings in various Magnussen and Kligman sensitisation tests with brake fluid containing up to 76% B-TTEGME (and 38% B-TEGME). Sensitisation was tested by epidermal and topical induction, followed by topical challenge under occlusion in guinea-pigs.

Respiratory sensitisation

Endpoint conclusion

Additional information:

Not applicable

Migrated from Short description of key information:
Not applicable

Justification for classification or non-classification

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.