Registration Dossier
Registration Dossier
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EC number: 201-089-0 | CAS number: 78-16-0
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
NOEC (14 d): 30.4 mg/L (Toxicity control of ready biodegradation test OECD 301B)
Key value for chemical safety assessment
Additional information
Studies on the toxicity
of 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate
(CAS 78-16-0) to aquatic microorganisms are not available. Therefore the
assessment of the toxicity to microorganisms is based on the NOEC
determined in the toxicity control reported in the study on ready
biodegradability. This approach is suitable for substances with high
degrading rates or no degradation inhibition in the positive control in
ready biodegradability tests. This is in accordance with the Guidance on
information requirements and chemical safety assessment (Chapter R.7b:
Endpoint specific guidance, ECHA 2012).
A substance can be assumed to be not inhibitory to aquatic
microorganisms, if in the toxicity control of a ready biodegradation
test more than 25% degradation based on CO2 evolution occurred within 14
days (OECD guideline 301). For
2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS
78-16-0) a biodegradation test according to OECD guideline 301B is
available (Muckle, 2009). The test includes a toxicity control, which
contains 30.4 mg/L of the test substance and 26.8 mg/L of the reference
material (Anilin). The toxicity control attained 41.8% degradation after
4 days of incubation (80.4% after 14 d). Hence, the substance is not
toxic to aquatic microorganisms and the test item concentration of 30.4
mg/L in the toxicity control can be used as NOEC. As it can be seen in
the data matrix of the category justification in section 13 and the
overall endpoint summary IUCLID 6.1, all reliable data in the category
support the hazard assessment of each category member by showing a
consistent pattern of results, i.e. no microbial inhibition
and no toxic effects were observed to aquatic organisms up to the limit
of water solubility.
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