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EC number: 235-935-5
CAS number: 13052-09-0
Basic Toxicokinetics for
1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate) (CAS#
In order to fulfill the requirements for
submission of a REACH dossier according to Annex IX of REACH Regulation
(EC) No.1907/2006 (for substances >100 tones/year) and in
absence of data on the toxicokinetics and dermal absorption, an
assessment of toxicological behaviour is required. No
studies are available on the toxicokinetics, metabolism and distribution
of 1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate).
The molecular structure of
The substance can be considered readily
biodegradable and no hydrolysis study was performed. There are also no
measurements to determine breakdown products.
Below are some physical chemical
properties of 1,1,4,4-tetramethylbutane-1,4-diyl
>6.5 (7.1 extrapolated)
The vapor pressure of test substance at 25°C is well below 0.01 Pa or 0.1 µBar.
(In the range of 10-6 – 10-9 Pa).
bis(2-ethylperoxyhexanoate) is classified as a peroxidetype
Flammability is an intrinsic hazard in this class.The
Self-Accelerating Decomposition Temperature (SADT) of the substances is
35°C (reference SADT: CLP regulations 18.104.22.168 and UN Recommendations on
the Transport of Dangerous Goods, Manual of Tests and Criteria, 5th
revised edition, sub-sections 28.1, 28.2, 28.3 and Table 28.3.)
available physico-chemical and toxicological information of the
substance has been evaluated and used to assess the toxicological
behaviour. The results of this analysis will address the question on how
the chemical will react in the body.
The ECHA “Guidance
on information requirements and chemical safety assessment Chapter R.7c:
Endpoint specific guidance May 2008” document provides
guidance, which physico-chemical properties commonly determine oral,
inhalatory and dermal absorption, distribution, metabolism and
elimination of substances(Link:http://echa.europa.eu/documents/10162/13632/information_requirements_r7c_en.pdf)
Based on the
log Pow of >6.5, vapor pressure and water solubility, the substance is
not expected to penetrate the skin to a significant degree. The
substance is not irritating to skin and increased absorption due to
damaged skin is therefore not likely.
absorbed however, the peroxide would undergo thermal decomposition at
body temperature. There is no information on the actual breakdown
on the low vapor pressure and pattern of use, inhalation is not expected
to be a major route of exposure. If inhalation of the peroxide does
occur, as stated above it will rapidly decompose. There is no
information on the actual breakdown products formed.
oral gavage study in rats, resulted in effects on the kidneys of males
(alpha 2μglobulin), livers of males and females (increase liver weights,
diffuse hepatocellular hypertrophy) and thyroid follicular hypertrophy
and minimally-slightly increased extramedullary hemopoiesis at 30
mg/kg/day. The liver effects were considered adaptive and the alpha
2μglobulin is specific to the male rat. The effects on the thyroid are a
secondary effect due to increased metabolism of T3/T4 and the
observations in the spleen are caused by an increased demand.
While it is
not possible to establish the causative agent of the effects noted in
the OECD422 study with the peroxide, (i.e. peroxide or breakdown
products), the peroxide is expected to quickly decompose at body
temperature. There is no information on the actual breakdown products
toxicokinetic data is not available on
1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate), if
absorbed, it is expected to breakdown rapidly. There is no information
on the actual breakdown products formed.
1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate) is not
expected to 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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