Registration Dossier

Administrative data

Description of key information

B-TTEGME applied in brake fluids was well tolerated in rabbits (and guinea-pigs) after dermal and ocular testing for irritation and corrosion. Scoring values were slight and reversible. The test substance is considered to be non-irritating for skin and eye. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

The skin and eye irritation and corrosion of B-TTEGME were studied by read-across with data from various test materials, including Brake Fluid DOT4 Super, Brake Fluid DOT 4 and B-TEGME. Similarity with B-TTEGME was based on a common functional group, common precursors and/or likelihood of common breakdown products and common constituents, as also described in a separated justification document in Section 13.

 

The key study for dermal irritation was conducted in vivo by semi-occlusive testing of a brake fluid containing 76% B-TTEGMEof which ca. 45% was B-TEGME, corresponding with 37% in the tested brake fluid. Application on rabbit skin at the dose of 0.5 mL during 4 hours demonstrated that the substance was not irritating to the skin up to 7 days after application (Shell,1990c). This study was applied according to OECD 404 guideline and was considered to be adequate, reliable and relevant.Weight of evidence fromB-TEGME, applied to the same method by semi-occlusive topical application on rabbit skin for 4 hours, demonstrated that the substance was not irritating to the skin up to 7 days after application (Clariant, 1995c). B-TEGME applied to rabbit skin (for 1, 5, 15' and 20h) and rabbit ear (for 20h) induced doubtful erythema only after 20h exposure to the skin and ear. Observations on day 8 after exposure did not reveal any findings (BASF, 1974b).

Supporting studieswith brake fluid (e.g. containing 38% B-TTEGME of which ca. 50% was B-TEGME, corresponding with 17% in the tested brake fluid; Shell, 1990a) conducted according to OECD 404 also confirmed the absence of skin irritating potential (Shell, 1975 and 1977).

 

The key study for eye irritation was conductedin vivoon rabbit eyes by testing a brake fluid containing 76% B-TTEGMEof which ca. 45% was B-TEGME, correspond ding with 37% in the tested brake fluid. Application was done according to guideline OECD 405at the volume of 0.1 mL (Shell, 1990d). Some irritation (conjunctival redness, slight chemosis and slight ocular discharge) was observed, however with a mean score of 0.3 resolving within 48-72 hours of treatment.Weight of evidencefrom B-TEGME did not reveal eye irritation when applied to the same method undiluted at 0.1 mL in one study (Clariant, 1995b). In an older study with B-TEGME, slight irritation was observed, however the method was different and the effect was reversible within 8 days(BASF, 1974c).

A slight and reversible conjunctival reaction (mean score of 0.4 only for conjuctival redness), was also observed in a supporting studywith abrake fluid containing 38% B-TTEGME,of which ca. 45% was B-TEGME, corresponding with 17% in the tested brake fluid (Shell, 1992c). Two other supporting studies did not reveal any ocular findings (Shell, 1975 and 1977). The cornea and iris were never visibly affected by the test material.

 

The findings were therefore not significant for classification.

Justification for classification or non-classification

B-TTEGME in brake fluids did not result in skin irritation, therefore no classification is warranted.

B-TTEGME in brake fluids caused some slight and reversible conjuctival redness and chemosis on the eyes (with a mean score of 0.3 -0.4), however there was no corneal opacity nor iris change, therefore classification is not warranted.