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EC number: 701-200-7
CAS number: -
The oral LD50 for male rats was 2.72 (2.52-2.93) g/kg bw, the oral LD50 for female rats was 2.15 (1.61-2.89) g/kg bw.The rat inhalation LC50 for 1 hour was >4.92 mg/L.The dermal LD50 value was >2.0 g/kg bw in rabbits.
The acute inhalation toxicity of
multiconsituent aluminium potassium fluoride in the rat was investigated
in a GLP compliant, non-guideline study. Despite some minor restrictions
in design and/or reporting, the study is considered as adequate for
One group of 5 male and 5 female rats was
exposed whole body to a dust atmosphere of the test substance. The
duration of the exposure was 1 hour followed by a 14 day observation
period. The gravimetric concentration of test article in the test
atmosphere was 4.92 mg/l. Particle size analysis of the exposure chamber
revealed a mass median diameter of 1.30 µm and geometric standard
deviation of 1.58.
Four of the test animals died during the
study. Irregular breathing, poor coat quality, yellow/brown stained fur,
lethargy, crusty eye, crusty nose, and crusty muzzle were observed among
the test animals during the study period. Necropsies revealed no gross
lesions in 5 of 10 test animals. Abnormalities of the small intestine,
stomach, and heart were observed in the remaining test rats. Based on
the observed mortality it can be concluded that the 1-hour LC40 of the
test substance is 4.92 mg/L which would correspond to a 4-hour LC40 of
1.23 mg/l when applying Haber's rule. The 4 -hour LC50 will be slightly
above this concentration.
on the above observations, the inhalatory LC50, 4h value of
multconstituent aluminium potassium fluoride in rats was established to
be within the range of 1 – 5 mg/L and therefore the test
to be classified as Category 4 H332 'Harmful if inhaled' according to
Classification, Labelling and Packaging of Substances and Mixtures (CLP)
Regulation (EC) No. 1272/2008.
Three acute oral
toxicity studies equivalent or similar to OECD guideline 401 are
available (Hazleton Laboratories, 1985a,b,c). Different multiconstituent
aluminium potassium fluoride batches were tested: aluminium potassium
fluoride 100 FLUX (AT-1 -KC), aluminium potassium fluoride NK FLUX
(AT-2-NK) and aluminium potassium fluoride NK FLUX (AT-3-NL). Different
dose levels were tested in the studies. The following results were
observed regarding mortality:
fluoride 100 FLUX (AT-1-KC):
Males: 2.55 g/kg: 0/5
(0 of 5 animals); 2.75 g/kg: 3/5; 3.57-5.00 g/kg: 5/5;
Females: 1.30 g/kg:
0/5; 1.82 g/kg: 2/5; 2.55 g/kg: 3/5; 3.57-5.00 g/kg: 5/5.
fluoride NK FLUX (AT-2-NK):
Males: 3.57 g/kg: 0/5
(0 of 5 animals); 5.00 g/kg: 3/5; 7.00 g/kg: 5/5;
Females: 2.55 g/kg:
0/5; 3.57 g/kg: 0/5; 4.25 g/kg: 3/5; 5.00 g/kg: 5/5.
fluoride NK FLUX (AT-3-NL):
Males: 3.57 g/kg: 1/5
(1 of 5 animals); 5.00 g/kg: 3/5; 7.00 g/kg: 5/5;
Females: 2.55 g/kg:
0/5; 2.75 g/kg: 3/5; 3.00 g/kg: 5/5; 3.57 g/kg: 5/5; 5.00 g/kg: 5/5.
In the animals which
died histopathological lesions were observed mainly in the
gastro-intestinal tract, primarily in the stomach.
most critical LD50 values were observed when testing aluminium potassium
fluoride 100 FLUX (AT-1-KC): for males the LD50 value was 2.72
(2.52-2.93) g/kg bw and for females the LD50 value was 2.15 (1.61-2.89)
Two acute inhalation
toxicity studies with rats are available (American Biogenics
Corporation, 1985a,b). In
the first study, one group of 5 male and 5 female rats was exposed to
4.92 mg/L multiconstituent aluminium potassium fluoride for 1 hour,
followed by an observation period of 14 days. 1 male and 3 females died.
Thus the LC50 for 1 hour was >4.92 mg/L. Clinical signs that were
reported were irregular breathing, poor coat quality, yellow/brown
stained fur, lethargy, crusty eye, crusty nose and crusty muzzle. Abnormalities
of the stomach (multifocal erosions, diffuse red brown discoloration of
glandular mucosa), glandular stomach (mucosa smooth and discolored red
brown), heart (diffusely pale, tan discoloration, mottling) and small
intestine (dark contents) were observed in 2 males and 3 females.
In the second study,
one group of 5 male and 5 female rats was exposed to
3.4 mg/L aluminium potassium fluoride for 1 hour, followed by an
observation period of 14 days. One female died. Thus de LC50 for 1 hour
was >3.4 mg/L. Clinical signs that were reported were irregular
breathing, ataxia, lethargy and crusty nose. No
gross abnormalities in the survivors were noted. Abnormalities of the
heart and stomach were observed in the female that died during the
Using modified Haber's
law (Cnx t = constant) and using n=1 as a default value in
accordance with Chapter R.184.108.40.206 of REACH Guidance on information
requirements and chemical safety assessment for extrapolation from
shorter to longer exposure duration, the 4 h LC50 is calculated to be
>1.23 mg/L (starting point for this calculation is the highest level of
4.92 mg/L/1h at which 1 male and 3 female rats died). As at the
extrapolated 4 h figure, 1.23 mg/L, the mortality number was 4/10
animals and as the classification limits for aerosols/particulates for
classification as harmful are: 1 < LC50 ≤ 5 mg/L/4h, it is expected that
the LC50 figure of the substance falls within the classification range
Supporting data for
not classifying the substance in a higher category is the result that no
mortality was observed when rats were exposed 6 hours/day, 5 days/week
for 28 days up to a concentration of 0.6 mg/L aluminium potassium
fluoride (see section on repeated dose toxicity).
the dermal route, three
studies (equivalent or similar to OECD guideline 402) are available (Hazleton
Laboratories, 1985d,e,f). Different
aluminium potassium fluoride
batches were tested: aluminium potassium fluoride 100 FLUX (AT-1 -KC),
aluminium potassium fluoride NK FLUX (AT-2 -NK) and aluminium potassium
fluoride NK FLUX (AT-3 -NL).
In the studies, five male and five female rabbits were administered a
single dermal dose of 2.0 g/kg bw and held for an observation period of
14 days. No mortality and no other effects were observed and/or
reported. The LD50 value was >2.0 g/kg bw for all three tested batches
of aluminium potassium fluoride.
the results of the available acute toxicity studies, no classification
is warranted for acute oral and dermal toxicity. Regarding
the inhalation route of exposure, in accordance to EU Classification,
Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC)
the substance has to be classified as Cat.
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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