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EC number: 250-418-4
CAS number: 30989-05-0
accordance with column 2 of REACH Annex IX (section 9.4) and Annex X
(section 9.4), tests for the effects on terrestrial organisms "do not
need to be conducted if direct and indirect exposure of the soil
compartment is unlikely". The Guidance on information requirements and
chemical safety assessment, Chapter R.7C: Endpoint specific guidance,
sections R.18.104.22.168c and R.22.214.171.124d, pages 109 and 110, respectively,
specifies that "in the case of ready biodegradable substances which are
not directly applied to the soil it is generally assumed that they will
not enter the terrestrial environment and as such there is no need for
testing of soil organisms".
will not be applied to soil, is readily biodegradable, hydrolyses
quickly and has a low potential for bioaccumulation, i. e., the log Pow
is << 3 and the soil organic carbon partition coefficient Koc is 0.008.
Therefore, it is very unlikely that B-TEGME will enter the terrestrial
compartment directly or indirectly from sewage treatment plants.
Furthermore, it is likely that the hazard from B-TEGME for terrestrial
orgnanisms is low since B-TEGME is not toxic to aquatic (freshwater)
soil of 0.0283 mg B-TEGME/kg soil dw was calculated using the aquatic
PNEC and equilibrium partitioning method. Based
on these characteristics, B-TEGME is not expected to cause adverse
effects on organisms of the terrestrial habitat.
arguments for waiving the terrestrial toxicity studies comes from the
criteria for "no hazard" which are specified in the draft guidance for
Chapter B8 (Guidance on information requirements and chemical safety
assessment, Part B: Hazard Assessment , Draft new chapter B.8 Scope of
Exposure Assessment, draft version 23 February 2010, page 12).
of significant ecotoxicological effects (and thus "no hazard") may be
concluded if all of the following criteria are met:
The intrinsic properties of the substance are well below the criteria
for classification as dangerous (hazardous) in accordance with Directive
67/548/EEC (or Regulation (EC) No 1272/2008), using all available data.
the substance has a very low potential to bioaccumulate in aquatic
species (e.g. fish) i.e. experimentally determined BCF < 10. For organic
substances an alternative criterion, log Kow < 2.0 can be applied
the substance is readily biodegradable (this criterion does not apply to
the aquatic toxicity has to fulfil both of the following criteria:
acute, short-term E(L)C50 > 1000 mg/l or> water solubility,or no
significant adverse effects recorded at 100 mg/l in acute, short-term
aquatic toxicity tests and validated QSAR data showing acute effects
(E(L)C50) > 1000 mg/l
chronic long-term NOEC (or equivalent ECx; e.g. EC10) > 10 mg/L
The substance shall not have adverse effects on terrestrial organisms,
meaning that no adverse effects are reported in any of the tests
required under Annex IX of REACH at the maximum test concentrations
prescribed by the respective OECD guidelines.
might be the case that no studies on terrestrial organisms are available
based on considerations that direct and indirect exposure of the soil
compartment is unlikely. If a registrant has adapted the standard
information requirements, this has to be well documented and justified
in the registration dossier. Thus, the justification given for waiving
the tests should either refer either to exposure considerations or it
should be based on relevant substance properties, such as partitioning
The substance shall not be identified as having or be suspected to have
endocrine activity from in vivo or in vitro tests, nor from the
application of relevant (Q)SAR models or other structural alerts which
may give rise any concern for endocrine-disrupting properties (DG
Environment, ENV.D4./ETU/2005/0028r; http:/ec.europa.eu/
requirements are addressed for B-TEGME as follows:
B-TEGME has a log Kow of -4.37 and hence a very low risk for
B-TEGME is readily biodegradable
- The EC50 values obtained in the
acute, short term aquatic tests were > 100 mg B-TEGME/L
QSAR calculations with ECOSAR (v1.00) as implemented in EPIwin 4.0
support the tests as they indicate that the EC50 values for fish
daphnids and algae are >>1000 mg B-TEGME/L (see page 3 of the printout
attached to this waiver)
The long-term NOEC from algae is >> 10 mg B-TEGME/L
B-TEGME is not expected to have adverse effects on terrestrial organisms
B-TEGME is not identified as having or be suspected to have endocrine
activity from in vivo or in vitro tests
arguments support that there is no ecotoxicological hazard arising from
B-TEGME and that the hazard is already appropriately described with the
available studies. This supports the above argumentation that
terrestrial toxicity tests are not needed for B-TEGME.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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