Registration Dossier
Registration Dossier
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EC number: 404-986-7 | CAS number: 74227-35-3 BDS-HEXAFLUOROPHOSPHATE; BDS-HEXAFLUORPHOSPHAT; ESACURE 1004
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Short description of key information on bioaccumulation potential result:
Assessment of toxicokinetics behaviour of the Notification dossier no.00-05-0360.
Key value for chemical safety assessment
Additional information
Assessment of toxicokinetic behaviour:
When the test substance was administered by single dose to
rats in the acute oral toxicity study (limit test), it was
necessary to reach a dose level of 5110 mg/kg to find toxic
effects leading to the death of some animals (i out of 5 in
both male and female groups) This could indicate the
compound was either very scarcely absorbed or, if absorbed ,
was unable to produce blod or tissue levels which exceeded
the toxicity threshold. Also in the acute subcutaneous
toxicity study in rabbits (3 males + 3 females) there was no
evidence of any systemic absorption (LD50 > 2000 mg/kg).
Data obtained from the 13-week oral toxicity study after
repeated administrations performed at the dose level of 0,
6.81, 21.5, 68.1 and 215 mg/kg/day - the latter brought to
464 mg/kg/day - showed the toxic effects apparead were so
relevant as to cause death only in the latter group of
animals (6 males, 1 female). The subsequent
necropsy/hystopathology showed that toxicity was to be
ascribed to relevant changes observed in organs of the
endocrine system such as thyroids, pituitary and adrenals.
Liver, kidney and lungs were also affected by relevant
changes.
Activation of the hormonal system (with morphological
effects in the tyroids) was also observed at the two medium
doses (21.5 and 68.1 mg/kg/day), but these changes were not
able to produce toxic effects. Only the lowest dose (6.81
mg/kg/day) was completely devoid of any effect (NOEL).
Therefore systemic absorbtion of the test substance (or its
metabolites) after repeated administrations (with possible
cumulation kinetics above a threshold dose) could be
hypothesized in animals.
At the same time the value of octanol/water partition
coefficient (Pow ca. 10), showing that the compound can be
extracted from the aqueous phase by the organic phase, may
suggest a certain transfer from the aquatic system into
organism; a low potential for bioaccumulation is expected.
Discussion on bioaccumulation potential result:
When the test substance was administered by single dose to
rats in the acute oral toxicity study (limit test), it was
necessary to reach a dose level of 5110 mg/kg to find toxic
effects leading to the death of some animals (i out of 5 in
both male and female groups) This could indicate the
compound was either very scarcely absorbed or, if absorbed ,
was unable to produce blod or tissue levels which exceeded
the toxicity threshold. Also in the acute subcutaneous
toxicity study in rabbits (3 males + 3 females) there was no
evidence of any systemic absorption (LD50 > 2000 mg/kg).
Data obtained from the 13-week oral toxicity study after
repeated administrations performed at the dose level of 0,
6.81, 21.5, 68.1 and 215 mg/kg/day - the latter brought to
464 mg/kg/day - showed the toxic effects apparead were so
relevant as to cause death only in the latter group of
animals (6 males, 1 female). The subsequent
necropsy/hystopathology showed that toxicity was to be
ascribed to relevant changes observed in organs of the endocrine system such as thyroids, pituitary and adrenals.
Liver, kidney and lungs were also affected by relevant
changes.
Activation of the hormonal system (with morphological
effects in the tyroids) was also observed at the two medium doses (21.5 and 68.1 mg/kg/day), but these changes were not
able to produce toxic effects. Only the lowest dose (6.81
mg/kg/day) was completely devoid of any effect (NOEL).
Therefore systemic absorbtion of the test substance (or its
metabolites) after repeated administrations (with possible
cumulation kinetics above a threshold dose) could be
hypothesized in animals.
At the same time the value of octanol/water partition
coefficient (Pow ca. 10), showing that the compound can be
extracted from the aqueous phase by the organic phase, may
suggest a certain transfer from the aquatic system into
organism and therefore some bioaccumulation can not be excluded
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