Registration Dossier
Registration Dossier
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EC number: 211-309-7 | CAS number: 637-92-3
Endpoint summary
Administrative data
Description of key information
Additional information
As no complete data set is available for ETBE, the missing endpoints will be filled using read-across from either MTBE or TAME (see “RF _env_ analogue approach ETBE.pdf” attached to chapter 13 of the IUCLID registration dossier for a more details justification of the analogue approach). Comparing all available experimental results on toxicity of ETBE, MTBE and TAME, it seems likely that the chronic toxicity of ETBE is expected to be more similar to TAME than to MTBE. When read-across is used from TAME to ETBE a safety factor of 2 will be taken into account. However, in cases that only results are available for MTBE, these will be taken for read across and a safety factor of 10 will be applied effect parameters.
Only one reliable study is available for freshwater fish. The study is a non-GLP compliant OECD guideline study with the guppy Poecilia reticulata. The purity of the test substance was not known and the effect concentrations were based on nominal values. The 96 -h LC50 is > 974 mg/l (Slovnaft VÚRUP, a.s., 2005b). As no data is available for marine fish the data from MTBE are used for read-across, the lowest effect concentration in marine fish for MTBE is a 96-h LC50 of 574 mg/l in inland silverside (Menidia beryllina) (BenKinney et al., 1994), applying a safety factor of 10 to this value results in an effect concentration of 57.4 mg/l for ETBE. Both values will be used in the assessment.
An OECD212 5 day study on embryos/sac fry is available for ETBE with zebrafish. This established a NOEC of 64mg/l based on the sum of all lesions seen at each test concentration.
Two studies are available for freshwater invertebrates; one study is a GLP compliant OECD guideline study with Daphnia magna(SafePharm Laboratories, 2003a) The 48-h EC50 value from this study is 110 mg/l and is more critical than the other study which is also an OECD guideline study, but which has minor deviations (Slovnaft VÚRUP, a.s., 2005c). Furthermore, a study with the marine species Americamysis bahia(tested as Mysidopsis bahia) is available, the 96-h LC50 is 37 mg/l (T.R. Wilbury Laboratories, Inc., 1994). These values are used in the assessment.
No chronic studies in invertebrates are available for ETBE, chronic studies are, however, available for MTBE and TAME. A guideline study is available for MTBE with Daphnia magna, the 21-d NOEC is 51 mg/l (Wildlife International Ltd., 1999). A safety factor of 10 is applied to this value, resulting in an effect concentration of 5.1 mg/l for ETBE. For marine invertebrates a chronic guideline study is available for TAME with Americamysis bahia(T.R. Wilbury Laboratories, Inc., 2004). The 28-d NOEC is 3.39 mg/l, applying a safety factor of 2 results in an effect concentration of 1.7 mg/l for ETBE. These values are used in the assessment.
Two studies with algae are available; one study is a GLP compliant OECD guideline study withPseudokirchneriella subcapitata(tested as Selenastrum capricornutum) (SafePharm Laboratories, 2003b) The 72-h ErC50 value from this study is 1,100 mg/l and the 72-h NOEC is 7.5 mg/l. The effect concentrations from this study are more critical than the other study which is an OECD guideline study with Desmodesmus subspicatus, but this study has minor deviations (Slovnaft VÚRUP, a.s., 2005d). These values are used in the assessment.
No studies with micro-organisms are available for ETBE; a study with Pseudomonas putidais available for TAME, the 16-h EC10 is 25 mg/l (SafePharm Laboratories, 2003c), applying a safety factor of 2 to this value results in an effect concentration of 12.5 mg/l for ETBE. This value will be used in the assessment.
No studies with sediment and terrestrial organisms are available, however as the log Kow is very low (1.48) direct and indirect exposure of these compartments is not expected as was demonstrated by the exposure assessment.
No data on bird toxicity is available, however a large mammalian dataset is available and as the log Kow is very low (1.48) secondary poisoning is not expected.
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.
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