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EC number: 425-220-8
CAS number: 5945-33-5
Short description of key information on bioaccumulation potential result: Fyrolflex BDP is not expected to be absorbed by any of the three major exposure routes into the body.
An actual toxicokinetics (TK) study was not
performed on Fyrolflex BDP. The
(a)Physical chemical properties
The physical chemical characteristics
of Fyrolflex BDP shown in Table 1 were utilised when assembling
scientifically robust arguments to evaluate the potential uptake of the
substance into the body, its lifecycle within the body and its ultimate
loss i.e.Absorption,Distribution,Metabolism &Excretion.
Table1: Physical chemical properties of
An organic phosphorus based chemical with bulky side groups
Low; 0.415 mg/L
1.2 x 10-3Pa
The major routes of absorption are via:
To be absorbed substances must have the
ability to cross cell membranes, which may occur as a result of either
passive diffusion, if the substance is both water and lipid soluble, or,
by active mechanisms if these physical chemical properties are not
Fyrolflex BDP, has a Log P of 4.5 i.e.
it is lipophilic and thus is more soluble in lipid than water. However,
the Log P is > 4 which takes it outside of the most favourable criteria
for absorption (range -1 to 3.5). A value of > 4 would hinder the
ability of the substance to dissolve in gastric fluids and hence
preclude contact with the mucosal cell surface. This fact coupled with a
molecular weight which exceeds 500 (actual value 692) and low water
solubility would militate against any significant absorption.Any
potential concern with respect to possible micellular solubilisation of
the Fyrolflex BDP by reaction with bile salts in the small intestine may
be insignificant since there were no systemic toxic effects observed in
relevant in vivo studies at extremely high dose levels (up to 1000mg/L
in a 28-day repeat dose oral study).The above qualitative assessment of
potential absorption via the gastro-intestinal route is borne out by the
available toxicological data provided in two in vivo studies, described
in Table 2.
Table 2: Fyrolflex
BDP - Oral toxicity studies in the rat
Acute oral toxicity
Limit test in the rat
Fyrolflex BDP was dosed in arachis oil at a dose level of 2000mg/Kg. No signs of systemic toxicity were observed despite the fact that the dosing vehicle used was liable to emulsification and then digestion in the gastro-intestinal tract. The use of this dosing vehicle giving rise to significantly increased potential for absorption of test material than if a mineral oil had been employed as the vehicle.
28-day repeat dose oral (gavage) study in the rat
Fyrolflex BDP was dosed in PEG 400 for 28 consecutive days at dose levels of 15, 150 and 1000mg/Kg. There were no clinical signs of toxicity, no adverse effects on bodyweight or food consumption, no treatment-related effects on haematology, blood chemistry, urinalysis or organ weights and no macroscopic or microscopic abnormalities detected. The NOEL was 1000mg/Kg
Insofar as the dermal route is
concerned the available and relevant toxicological study data can be
found in Table 3.
Table 3: Dermal
toxicity data for Fyrolflex BDP
Acute dermal toxicity study
Fyrolflex BDP when dosed at 2000mg/Kg did not induce any signs of systemic toxicity.
Skin irritation study
Not a skin irritant
Eye irritation study
Not an eye irritant
Skin sensitisation study
Did not cause an allergic skin reaction
The available dermal toxicological data
coupled with the high molecular weight of Fyrolflex BDP militate against
any significant dermal absorption potential.
Inhalation of Fyrolflex BDP is not
expected. The substance is a viscous liquid at room temperature and has
a low vapour pressure. The Log P value is > 4 and this also does not
favour absorption via passive diffusion directly across the respiratory
The oral toxicity studies described in
Table 2 indicate no systemic toxicity after repeated dosing at levels of
up to 1000mg/Kg and this supports the premise that Fyrolflex BDP is
unlikely to be absorbed if it was inhaled.
BDP is a high molecular weight substance (> 500) and as such is
generally considered to be unable to readily cross cell membranes and
therefore will not be widely distributed in the body. In addition the
substance has a low water solubility which limits its ability to diffuse
through aqueous channels and pores. Although Fyrolflex BDP has a Log P
value of > 0 this physical chemical value alone is a poor surrogate for
prediction of its distribution into cells.
The available and relevant in vivo
toxicological information (28-day repeat dose oral study at dose levels
up to 1000mg/Kg) clearly indicates that no specific target organ or
tissue toxicity was observed and there were no changes in haematology or
blood chemistry or any signs of CNS effects.
The repeated dosing of the test
substance at 1000mg/Kg on 28 consecutive days without any overt signs of
toxicity supports the hypothesis that Fyrolflex BDP is unlikely to be
bioaccumulative. Although the Log P of Fyrolflex BDP is between 4 and 6
and there may be skin penetration into the stratum corneum there is
adequate toxicological data to show that there is little, or no,
systemic absorption. Fyrolflex BDP may persist in the stratum corneum
until such time as it is cleared when this outer keratinised layer is
Based upon the available and relevant
in vivo toxicological study data and the lack of systemic toxicity seen
following oral dosing at levels of 1000 and 2000mg/Kg Fyrolflex BDP and
despite the predominance of the liver as the centre for metabolic
activity following the oral exposure route it is likely that this
substance is not significantly metabolised.
The major routes of excretion of
substances from the systemic circulation are via urine and/or
faeces.Based upon the molecular weight (> 300) and low water solubility
of Fyrolflex BDP it is unlikely that urine will be a major excretion
route. Excretion in the faeces as a consequence of direct transfer from
the gastro-intestinal tract is potentially the major route for excretion
of mainly unchanged parent Fyrolflex BDP.
Based upon the Guidance provided in
REACH document Chapter R.7.c; specifically R.7.12 Guidance on
Toxicokinetics, Fyrolflex BDP is not expected to be significantly
absorbed by any of the three major exposure routes into the body. The
available and relevant physical chemical and toxicological data support
the contention that Fyrolflex BDP is unlikely to be widely distributed
in the body and may not undergo any significant metabolism before being
excreted unchanged in the faeces.
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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