Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

As no fertility studies were available for B-TTEGME, special attention to male and female fertility organs will be spent in the proposed 90 -day repeated dose toxicity study in rats. The toxicology testing strategy proposal further defines the tiered approach.


Short description of key information:
There were no fertility studies with B-TEGME. Fertility parameters will be further evaluated in the proposed studies.

Effects on developmental toxicity

Description of key information
The maternal/developmental NOAEL in a Charnoff & Kavlock rat study was determined to be at least 380 mg B-TTEGME/kg bw/day based upon a toxicity study up to 1000 mg brake fluid/kg bw/day. Prenatal developmental toxicity will be further studied in a prenatal developmental study in rats.
Additional information

The developmental toxicity of B-TTEGME was studied by read-across with data from 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 separate justification document in Section 13.

A screening developmental toxicity was performed in rats witha brake fluid containing 38% B-TTEGME, of which ca. 45% was B-TEGME corresponding with 17% B-TEGME in the tested brake fluid (Shell, 1993b). Doses administered were 9.5, 57 and 380 mg B-TTEGME/kg bw/day, based upon doses of 25, 150 and 1000 mg brake fluid/kg bw/day. This study was applied according to a Charnoff & Kavlock (CKA) design and in compliance with GLP, which was considered to be adequate, reliable and relevant. This study can therefore support further developmental toxicity testing. Dams were allowed to litter and the pups observed and weighed on days 1 and 5 post-partum, at which point the study was terminated. As there were no skeletal and visceral examinations in this study, it was considered as a supporting study for a final prenatal developmental toxicity study in rats. In this screening study, no treatment related effects on birth, live birth, or viability indices were found, neither were there treatment-related clinical effects on dams or pups, or gross abnormalities seen in the pups. The NOAEL for this study was at least 380 mg B-TTEGME /kg bw/day based on the NOAEL of 1000 mg brake fluid/kg bw/day. It must be taken into consideration that the brake fluid also contained other borated and non-borated glycol ethers and other components.

Toxicity to reproduction: other studies

Additional information

As no effects have been observed with brake fluid containing B-TTEGME in the study being available, classification is not warranted.

Justification for classification or non-classification

As there are no adverse effects seen up to the doses tested, there is no need for classification.

Additional information