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EC number: 201-174-2
CAS number: 79-07-2
assessment of the toxicity to soil macroorganisms except arthropods in
total 5 studies with Klimisch 2 are available. These studies are
publications and it is not stated if the studies were performed under
GLP. These publications provide information on short term- toxicity and
- to a limited extend - also for long-term toxicity.
to the above mentioned 5 publications, in total 8 further disregarded
studies are available. These studies were disregarded since the test
design had major differences to the modern test guidelines and/or the
lack of sufficient information on methods and results and/or an non
standard test species (Enchytraeus albidus) was used for an acute test.
These studies will not be discussed here.
be noted that Chloroacetamide is listed as reference substance in OECD
207, but not in the newer OECD 222.
studies were performed with artificial soil and the test design of these
studies was similar to the OECD 207. Since the studies were more or less
similar in the test design and the provided information, the results of
these studies are considered to have equal relevance and hence a weight
of evidence approach was followed, i.e., the mean of the LC50 of all
relevant studies was calculated. Since the data were all within the same
range, no data were excluded from this data set.
LC50 values provided in the relevant publications.
Yeardley, R.B., et al.
In total six tests performed, the mean was reported
Gibbs, M.H., et al.
Test duration longer than stated in the OECD 207 but considered as relevant since this LC50 represents a worst case. Indication that NOEC reproduction is 15 mg/kg dw.
Test duration longer than stated in the OECD 207 but considered as relevant since this LC50 represents a worst case.
Neuhauser, E.F., et al.
Gestel et al.
Mean of LC50 with test duration >= 14 days
calculation of the mean LC50 the data from Yeardley, R.B., et al. (1995)
were considered as one study even it was the mean of six experiments.
The LC50 of
30.4 mg/kg dw will be used for the risk assessment.
study from Yeardley, R.B., et al.(1995) 7 day and 14 day LC50 values
were provided which allows a first assessment of the evolution of
mortality after exposure to Chloroacetamide. The 7 day LC50 was 33.3 and
the 14 day LC50 was 33.1 mg/kg dw. Hence, there was only a minor change
from 7 to 14 days. It can be concluded that the main mortality of
Chloroacetamide occurred within the first 7 days. This supports that the
21 and 28 day LC50 values can also be used for the risk assessment of
study from Gibbs, M.H., et al. (1996) the adults were exposed for 21
days (OECD 222 reproduction test: 28 days). The exposure of the
juveniles and cocoons was performed for additional 42 days (total test
duration 63 days) (OECD +28 days after adult exposure). Juvenile
production and cocoon hatching were relatively low and did not met the
validity criteria outlined in the OECD 222 for the number of cocoons and
juveniles. The number of juveniles was less than the validity criterion
of at least 3 juveniles per adult worm. It must be stated that the test
design showed some deviations to the OECD 222, (e.g. adult exposure for
21 instead of 28 days) which
was adopted only in the year 2004 and was hence not available when the
study from Gibbs et al (1996) was performed. This limits the
interpretation of the results and hence, the results of this study are
considered to be not relevant as long-term toxicity data. The reported
NOEC for reproduction is 15 mg/kg dw. The data indicate that at 10 and
25 mg/kg dw the number of cocoons was lower when compared to the other
groups. Not clear concentration response was observed. Hence, no effect
on reproduction was observed up to 25 mg/kg dw.However,
a significant decline of the percent of replicates which showed
reproduction was observed at 10 and 25 mg/kg dw (even if statistics were
difficult due to the low number of cocoons/juveniles).This effect was
not observed at 15 mg/kg dw.It
was concluded that this study showed not effects on survival including
15 mg/kg dw. Sublethal effects were observed but the evaluation might be
limited due to the low number of cocoons and juveniles. There is no
indication that reproduction and sublethal effects are observed below 15
mg/kg dw. Hence, the LC50 of 29 mg/kg dw and the NOEC reproduction (15
mg/kg dw) are relatively close together (Gibbs, M.H., et al. ,1996).
This would indicate that the mortality caused by Chloroacetamide within
the first days of exposure is the driving factor for long-term toxicity
including reproduction. This is supported by the finding that the
mortality is mainly observed within the first 7 days (Yeardley, R.B., et
Due to the
deviations to the OECD 222, the results are considered as not relevant
as long-term toxicity data.
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