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EC number: 216-823-5
CAS number: 1675-54-3
There was no mortality noted in either
control, blank or vehicle control, or 1.0 mg/l test material. There was
no mortality noted in the first 24 hours at 1.8 mg/l. Within 48, 72 and
96 hr, two, six and eight fish, respectively, had died at 1.8 mg/l. All
fish exposed to 3.2, 5.8 or 10 mg/l died within the first 24 hrs.
Swimming behavior, equilibrium, respiratory
function and pigmentation were observed in a small number (1-3) of fish
exposed to 1 or 1.8 mg/l. All but respiratory function were noted
within 24 hours and did not appear to progress. Respiratory function
was initially noted in one fish after 24 hr and three fish after 96 hr
to 1.8 mg/l.
The LC50 (96 h) in Salmo gairdneri was
determined for BADGE. There was no mortality noted in either control,
blank or vehicle control, or 1.0 mg/l test material. There was no
mortality noted in the first 24 hours at 1.8 mg/l. Within 48, 72 and 96
hr, two, six and eight fish, respectively, had died at 1.8 mg/l. All
fish exposed to 3.2, 5.8 or 10 mg/l died within the first 24 hrs. The
96 hour LC50 is 1.5 mg/L in Salmo gairdneri (calculation).
Three 96-hour static toxicity tests were carried out with Salmo
gairdneri. The test media were renewed daily. The 96 hour LC50 for
the test material was determined to be 3.6 mg/L when the material was
directly added to the water medium. The 96 hour LC50 for the test
material was determined to be 2.3 mg/L when the test material was
delivered in acetone. These toxicity values are within the range of the
reported water solubility of the test material. When the test material
was sonicated in solution, the resulting LC50 value reported (7.7 mg/L)
was considered invalid, since physical toxicity was likely to have
played a role in the observed toxicity at these dose levels.
Based upon the results of the test the 24,
48, 72 and 96 h LC50 values, expressed in terms of the concentration of
the water-soluble fraction of EPIKOTE 828 present in the test medium
were calculated to be 4.4, 2.7, 1.8 and 1.2 mg/L, respectively.
Aqueous stock solutions of the water-soluble
fraction of EPIKOTE 828 were generated by recirculating dilution
water/culture medium through glass columns packed with inert
particulate material (pumice) coated with 5 -10% (m/m) EPIKOTE 828. O.
mykiss was exposed to serial dilutions of the stock solutions in tests
to determine the acute toxicity of the soluble fraction of EPIKOTE 828
It should be noted that the water-soluble
fraction of EPIKOTE 828 is composed principally of chemical species
other than the major component of the test material as supplied. The
principal water-soluble component is probably a diol formed by
hydrolysis of one of the two epoxide moieties present in the major
component of EPIKOTE 828.
In this study the results of the toxicity
tests are expressed in terms of the measured concentrations of the
water-soluble fraction of EPIKOTE 828 present in the aqueous test media.
The acute toxicity of EPIKOTE 828 to O.
mykiss was determined in a 96 h semi-static test with daily renewal of
the test media. Based upon the results of the test the 24, 48, 72 and 96
h LC50 values, expressed in terms of the concentration of the
water-soluble fraction of EPIKOTE 828 present in the test medium were
calculated to be 4.4, 2.7, 1.8 and 1.2 mg/L, respectively.
The 96-hour LC50 value of 2.0 mg/L for BADGE and BADGE-related resins is the geometric mean of four 96-hour LC50 values taken from valid exposure studies with BADGE and rainbow trout (Salmo gairdneri now Oncorhynchus mykiss).
Six acute freshwater fish studies were assessed for this endpoint. Four
studies were conducted with rainbow trout (Salmo gairdneri, now Oncorhynchus
mykiss), one study was conducted with zebrafish (Danio rerio)
and one study was conducted with the fathead minnow (Pimephales
promelas). The study conducted with fathead
minnows was deemed unacceptable for use due to inappropriate temperature
for the test species and also due to the fact that the test solutions in
the study were above the limit of the solubility. A
total of five studies (four with rainbow trout and one with zebrafish)
were determined to be of good quality and acceptable for use in risk
assessment. The acute tests with BADGE and rainbow trout gave varying
96-hour LC50 values of 1.2, 1.5, 3.6, 2.3 and 74.8 mg/L. The
acute test with BADGE and zebrafish reported a 96-hour LC50 of 2.4 mg/L. The
four lowest 96-hour LC50 values reported for rainbow trout (1.2, 1.5,
3.6, and 2.3 mg/L) were used to calculate a geometric mean value of 2.0
mg/L for this species. The 96-hour LC50 value of 74.8
mg/L was not used in the calculation of the geometric mean since it was
greater than 10-fold different from the other LC50 values. This
is in accordance with ECHA guidance from Chapter R.10 (section R.10.2.2). The
discrepancy in toxicity values is likely the result of one study testing
above the limit of solubility for the test material (however no specific
mention of insolubility was made in the study reporting the 96-hour LC50
of 74.8 mg/L). The lowest 96-hour LC50 value of 2.0
mg/L for rainbow trout was selected as the key parameter for this
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