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EC number: 939-253-5
CAS number: 68424-85-1
All rats receiving the test substance i.v.
experienced clear signs of toxicity, including death, and all but one
showed red urine during the first 4 h after the treatment.
study was conducted to determine the basic toxicokinetics of the
radiolabelled test substance, C12-16 ADBAC (30% active in water; 99.4%
radiolabelled purity), according to EPA OPP 85-1, in compliance with
GLP. Sprague-Dawley rats (10 animals per sex per group) were treated
with radiolabelled test substance. The study was conducted in four
phases: a single low dose (10 mg/kg); a single high dose (50 mg/kg); a
14 d repeated dietary exposure with non-radiolabelled test substance
(100 ppm) and single low dose of radiolabelled (14C) test substance (10
mg/kg); and single intravenous dose (10 mg/kg). Following the single
doses or the last dietary dose, urine and faeces were collected for 7 d.
A preliminary study had indicated that insignificant 14CO2 was
generated. Tissues, urine and faeces were collected and analysed for
radioactivity and faeces were analysed by TLC, HPLC and MS for
metabolites and parent compound. Following oral administration,
radiolabelled test substance was rapidly absorbed, although in very
limited amounts, consistent with its highly ionic nature. Residual 14C
in tissues was negligible after administration by gavage both after
single and repeated dosing, indicating low potential for
bioaccumulation. After i.v. administration a higher amount of
radioactivity (30−35%) was found as residue in the tissues. About 6−8%
of orally administered test substance is excreted in the urine whereas,
87−98% was found in the faeces. Since no data on bile duct-cannulated
rats are available, it was not possible to conclude if this
radioactivity accounts exclusively for unabsorbed test substance or not.
However, the i.v. experiment showed that 20−30% was excreted in the
urine and 44-55% in the faeces, suggesting that both the kidney and
liver are capable of excreting test substance once absorbed and that
absorption is higher than the % found in the urine after oral
administration. Based on the urinary mean value 3-4% (with a single peak
value of 8.3%) and biliary excretion values (3.7-4.6%), as well as on
the absence of residues in the carcass, as measured at 168 h, it can be
expected that the test substance absorption through the g.i. tract is
about 10% (conclusion not included in the study report; as assessed by
the Italian Rapporteur Member state in the biocides dossier; ECHA
biocides assessment report, 2015). Less than 50% of the orally
administered test substance was found to be metabolised to side-chain
oxidation products. In view of the limited absorption of the test
substance, the four major metabolites identified were expected to be at
least partially formed in the gut of rats, apparently by microflora. No
significant difference in metabolism between male and female rats or
among the dosing regimens was observed. Repeated dosing did not alter
the uptake, distribution or metabolism of test substance. Under the
conditions of the study, the test substance was found to have limited
absorption (ca. 10%; due to its ionic nature), negligible distribution
(no bioaccumulation), and majorly excreted majorly via faeces (87-98%)
following oral administration. However, following i.v. administration,
it was found to be widely distributed (30-35%) in tissues and excreted
both via faeces (40-55%) and urine (20-30%). Four major metabolites were
identified, formed via oxidation of the alkyl chain (Selim, 1987).
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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