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EC number: 310-290-3
CAS number: 161907-80-8
ErC50 > 448.8 mg/LNOEC = 448.8 mg/L
the assessment of the EC50 for freshwater algae, two studies are
available, one key study conducted with methyl borate esters containing
44% B-TTEGME (Shell 1999) and one supporting study with a brake fluid
which contains 35% B-TTEGME (Shell 1987).
the GLP compliant (key) study from Shell (1999) the growth inhibition of
methyl borate esters (containing 44% B-TTEGME) to Pseudokirchneriella
subcapitata was determined in a 72 h static algae growth inhibition
limit test according to EU Method C.3 and OECD 201. No relevant
restrictions appeared and the only disadvantage of this study is the
fact that the study was performed with a B-TTEGME containing mixture and
not with B-TTEGME as pure substance itself. The nominal test
concentrations were 0 (control) and 1000 mg methyl borate esters/L (=
440 mg B-TTEGME/L). The mean measured concentration was 1020 mg methyl
borate esters/L corresponding to 448.8 mg B-TTEGME/L. During the study,
the pH increased by more than 1 unit at the end of exposure, which is a
deviation to the C.3 and OECD 201 guidelines. Since the control cultures
showed exponential growth through the 72 hour exposure period and the
growth rates of the control cultures fulfilled the validity criteria
from OECD 201 (2006), this deviation is considered to have no effect on
the general outcome of the study. After 72 hours of exposure, the AUC of
the treated test group (448.8 mg B-TTEGME/L) was 16 % higher than the
control. After 72 hours of exposure, the average specific growth rate of
the treated test group was 9.4% higher than the control. Based on these
results, the NOEC for AUC and growth rate was =448.8 mg B-TTEGME/L. The
72 -hour EbC50 and ErC50 were both > 448.8 mg
the GLP compliant (supporting) study from Shell (1987) the growth
inhibition of a brake fluid (which contains 35% B-TTEGME) to Pseudokirchneriella
subcapitata was determined in a 96 h static algae growth inhibition
test. The test design was not based on a specific test guideline, but
the provided details were similar to the OECD 201. Restrictions of the
study are: (1) The treated test solutions were not replicated, (2) in
combination with the lack of replication, the spacing of 2 to 2.5 is
deemed to be too high to result in reliable results, (3) dose
verification was not performed, (4) counting of algal cells in 48
instead of 24 hour intervals, (5) the test design deviates in many
aspects from a more modern test design. The nominal test concentrations
were 0 (control), 1, 2, 5, 10, 20, 50, 100, 200, 500 and 1000 mg brake
fluid/L, corresponding to 0 (control), 0.35, 0.70, 1.75, 3.5, 7.0, 17.5,
35, 70, 175, and 350 mg B-TTEGME/L. In order to determine the growth of
the cultures, cell counts were performed at 0, 48 and 96 hours. Beside
the fact that the cell counts were not performed in 24 h intervals and
the validity criteria from OECD 201 cannot be strictly applied, control
cultures basically fulfilled the validity criteria from OECD 201 (2006).
The 96 -hour EC50 was 150.5 mg B-TTEGME/L corresponding to 430 mg brake
fluid/L . Due to the deviation from the modern test design of algae
growth inhibition tests, this study is considered to have only limited
relevance. Major criticism points are the counting of algal cells in 48
instead of 24 hour intervals and the lack of replication of the treated
test solutions. The guideline allows to perform the test with less than
3 replicates/test group if the aim of the study is the determination of
the ECx-values. However, for this approach the spacing of 2 to 2.5 is
deemed to be too high to result in reliable results.This is reflected by
the very wide 95% C.I. of the effect concentrations.
GLP (key) study from Shell (1999) was a guideline compliant study and
was therefore selected as key study. The EC50 from this study was >448.8
study from Shell (1987) provided an EC50 of 150.5 mg B-TTEGME/L. Due to
the above restrictions the test results from Shell (1987) were not
considered as relevant for the risk assessment.
conclusion, the NOEC of 448.8 mg B-TTEGME/L and the EC50 value of >448.8
mg B-TTEGME /L are considered reliable and sufficiently conservative to
assess the toxicity of B-TTEGME on algae.
EC50 for freshwater algae used for the further risk assessment is 448.8
value is higher than the limit for classification and labeling, i. e.,
higher than 100 mg B-TTEGME/L.
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