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EC number: 221-975-0
CAS number: 3302-10-1
Details on results:
To determine any potential for aquatic bioaccumulation of the submission
substance, the bioconcentration factor for fresh water fish was
determined using carp (Cyprinus carpio). The valid test was performed
compliant with GLP according to OECD 305C (1981), following the steady
state method. Based on preliminary acute toxicity testing (LC50 (Oryzias
latipes; 48 h) = 160 mg/L), two exposure concentrations of 1.0 and 0.10
mg/L had been applied in a flow through system using glass aquaria (25
Aquatic test item concentrations were determined 2 times a week, and
concentrations in fish were determined after two, three, four and six
weeks. At each time point 2 fish per concentration level were used and
extracted separately after weighing (wet weight). A mean lipid content
of 3.5% had been determined at the start of exposure for the fish used.
Steady state (plateau) was reached between 2 and 3 weeks for 1 mg/L
nominal concentration (>= 0.932 mg/L <= 0.936 mg/L measured) and between
3 and 4 weeks for 0.1 mg/L nominal concentration (>= 0.0925 mg/L <=
0.0943 mg/L measured). The highest BCF determined based on individual
concentration results for fish (n= 2 at each time point) was 7.0 L/kg
(whole body wet weight).
Concluding, these valid results convincingly demonstrate that there is
no relevant aquatic bioaccumulation potential for
3,5,5-trimethylhexanoic acid (NITE, 2000).
No significant bioaccumulation potential is expected for
3,5,5-trimethylhexanoic acid based on a measured BCF according to the
MITI protocol, which corresponds to OECD 305 C (NITE, 2008). The BCF at
the lower test concentration (0.1 mg/L) was < 3.1-7.0, while the BCF at
the higher test concentration (1 mg/L) was lower (0.5-1.7).
A supporting QSAR study is available (ECT, 2008). The log BCF of
3,5,5-trimethylhexanoic acid was estimated to be 0.5 (BCF 3.2 L/kg ww)
by using the BCFWIN program (v2.17) as part of US EPA EPI Suite(TM).
This fits very well to the experimentally determined data and further
corroborates that the submission substance will not bioaccumulate.
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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