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EC number: 250-418-4
CAS number: 30989-05-0
The LD50 derived from the key studies were:
LD50 (oral, rat) >2000 mg/kg bw, according to OECD 401, Clariant, 1995;
LD50 (dermal, rat) > 2000 mg/kg bw,
according to OECD 402, Shell, 2010.
B-TEGME and brake fluids were very well
tolerated in rats after both acute oral and dermal dosing. LD50 values
were both above the limit dose of 2000 mg/kg body weight for B-TEGME and
brake fluids, therefore B-TEGME is considered to be very safe.
Inhalation toxicity testing was waived based upon low vapour pressure.
Based on these results, B-TEGME is not acute
Table 2. Body weight and body weight gain (gram)
Body weight gain
In an oral acute toxicity study according to OECD 401, 5
male and 5 female animals were gavaged with the limit dose of 2000 mg/kg
bw/d of the test substance.
After application neither deaths nor clinical symptoms
occurred. Development of body weight was not impaired. The animals were
killed at the end of the observation period of 14 days and showed no
macroscopically visible changes.
Acute oral toxicity testing to B-TEGME in the Wistar rat
yielded a median lethal dose level above 2000 mg/kg body weight in both
male and female animals.
A group of ten animals (five males and
five females) was given a single, 24 hour, semi-occluded dermal
application of the undiluted test material to intact skin at a dose
level of 2000 mg/kg bodyweight. Clinical signs and bodyweight
development were monitored during the study. All animals were subjected
to gross necropsy. There were no deaths, no signs of systemic toxicity,
no signs of dermal irritation. All animals showed expected gains in
bodyweight over the study period and there were no abnormalities at
acute dermal median lethal dose (LD50) of the test material in
the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
The key study for acute oral toxicity
with B-TEGME (Clariant, 95.0103, 1995) yielded an LD50
greater than 2000 mg/kg body weight in both male and female rats. The
study was performed according to OECD 401 and EU B.1 method, and was in
compliance with GLP. There were no deaths, clinical signs, adverse
effects on body weight or macroscopic changes. A supporting study (BASF,
XXIII 535, 1974) even showed an LD50 value of more than
3000 mg B-TEGME/kg body weight, with clinical signs such as dyspnoe,
slight apathy, ataxia, slight dehydration and acute heart dilatation
with hyperaemia. The latter study was supportive (non-GLP).
Acute oral toxicity was also tested in
rats in studies with brake fluids ; these studies were considered
as supportive studies since also other components than B-TEGME were
present in the brake fluids. In the study from Shell (Shell, SBGR.92.011,
1992) with brake fluid containing 17% B-TEGME, the LD50 was
calculated to be greater than 850 mg B-TEGME /kg bw, based
upon LD50 values of 5000 mg brake fluid/kg body weight for the mixture
tested. The principal signs of reaction to treatment were
abasia/ataxia, hunched posture, piloerection, lachrymation and, at a
later stage, unkempt appearance and staining/soiling of the anogenital
fur. Less common clinical signs were lethargy among male rats,
bradypnoea among the females and prostration in rats of either sex.
Recovery was advanced by day 2 and complete by day 8 and no macroscopic
changes were apparent on day 15. In another study from Shell (Shell,
SBGR.90.189, 1990) with brake fluid containing
37% B-TEGME, the LD50value was greater than 1850 mg
B-TEGME/kg body weight based upon a LD50 value above 5000 mg brake
fluid/kg body weight fot the mixture tested. Clinical signs included
hunched posture, lachrymation, abasia, lethargy, unkempt appearance and
encrustation of the periorbital zone. Recovery was complete by day 3 and
no macroscopic changes were apparent during necropsy on day 15. Most
likely other components of brake fluids may have contributed to
the clinical signs observed in the animals.
The key study for acute dermal toxicity
with B-TEGME was performed according to OECD 402 and EU B.2
and GLP guidelines (Shell, 2259-0065, 2010). A group of ten five male
and five female Wistar rats was given a single, 24-hour, semi-occluded
dermal application of the undiluted test material to intact skin at the
limit dose of 2000 mg/kg bw. There were no deaths, clinica1 observations
or signs of systemic toxicity; neither were there signs of dermal
irritation. All animals showed expected gains in bodyweight over the
study period and no abnormalities were detected at necropsy. The dermal
LD50 was found to be greater than 2000 mg/kg bodyweight.
Acute dermal toxicity was also tested
with brake fluids in studies, which were considered to be
they contained a lower amount of B-TEGME
as well as other components.
The acute dermal LD50 of B-TEGME in a brake fluid containing 17%
B-TEGME in rats was more than 340 mg B-TEGME/kg body weight based upon
an LD50 greater than 2000 mg brake fluid/kg bw under
occlusive dressing for 24 hours (Shell, SBGR 92.011, 1992). There were
no clinical signs, adverse effects on body weight or macroscopic changes
on day 15, except for some minor vascular congestion of the dermis
underlying the site of application in some rats. The acute dermal LD50
of B-TEGME in a brake fluid containing 37% B-TEGME in rats was greater
than 850 mg B-TEGME/kg body weight, based upon an LD50 of
2000 mg brake fluid/kg body weight under occlusive dressing for 24 hours
(Shell, SBGR 90.189, 1990).
acute inhalation toxicity study (Inhalation Risk Test, IRT) could
not be used for assessment (Klimisch code 3)
because of significant methodological deficiencies (substance weight
increase instead of decrease during IRT, probably due to hygroscopic
properties of the test substance. Therefore, one cannot be sure whether
the animals were exposed to any test substance at all (BASF,
XXIII 535, 1974). Further inhalation toxicity testing was waived based
upon a low vapour pressure (120 Pa at 20°C).
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 acute toxicity under
Regulation (EC) No. 1272/2008.
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