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EC number: 310-290-3
CAS number: 161907-80-8
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.
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.
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
no effects have been observed with brake fluid containing B-TTEGME in
the study being available,
classification is not warranted.
As there are no adverse effects seen up to the doses
tested, there is no need for classification.
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