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EC number: 907-672-2
CAS number: -
Acute toxicity information is available for the oral, inhalation and
dermal route. The inhalation study received a K2 Klimisch score while
all other studies were categorised K4. All studies indicated that no
classification for acute toxicity is warranted.
One animal at the 2500 mg/kg dose and one at the 5000 mg/kg dose
exhibited alopecia. One animal at the 2500 mg/kg dose, two at the 2500
mg/kg dose, two at the 3500 mg/kg dose, and 8 at the 5000 mg/kg dose
were hypoactive. Bloody appearing urine was seen in one animal at the
3500 mg/kg dose and in 2 at the 5000 mg/kg dose. One animal at the 3500
mg/kg dose and one at the 5000 mg/kg dose had ptosis. Ataxia was seen in
one animal at the 3500 mg/kg dose and in 5 animals at the 5000 mg/kg
dose. Excessive lacrimation was observed in one animal at the 3500 mg/kg
dose and in 4 animals at the 5000 mg/kg dose.
Gross necropsy: 20 animals were necropsied at terminal sacrifice. One
had very pale lungs. One had very pale colored kidneys. One had
unilateral hydronephrosis and white sediment in the same kidney. The
remaining 17 animals were not remarkable.
Body weight (Gm)
Mortalities / dosed
Day 0 M/F
Day 7 M/F
Day 14 M/F
A light aerosol mist was visible during the entire exposure and the
calculated mean nominal concentration was 4,15 mg/L of air.
The minium lethal dose was found to be in the range of 5.0 to 7.5 g /kg.
Survival time was 2 to 3 days. Body weight loss was observed in the
animals exposed to 2.0, 3.2 and 4.2 g/kg. Nevertheless, the animal
exposed to 5.0 g/kg did not show any weight loss.
Succumbing animals became shaky and lethargic overnight. All animals
except the one treated with the lowest dose showed this condition to
some extent. At autopsy, no specific abnormalities were observed
macroscopically aside from pulmonary congestion, which is often observed
in such instance.
For acute toxicity via the oral route, a weight-of-evidence
approach was applied. In the oldest study study report (Younger, 1953) a
minimal lethal dose of 2.4 – 2.8 mg/kg for rats was observed. In another
study report (Younger, 1956) an LD50 of 2620 mg/kg body weight for rats
was calculated. In a third study (Branch, 1979), Acryloid HF-422, a
formulation of 70.8% DBPP and 29.9 % n-butylmethacrylate polymer was
tested on rats. An LD50 of 4307 mg/kg body weight was calculated in this
study. This LD50 is probably an underestimation since the test material
consisted of only 70.8% DBPP. An LD50 around 3049 mg/kg body weight
would be a more realistic value taking into account the concentration of
For acute toxicity via the inhalation route, read-across to
Acryloid HF-422, a formulation of 70.8% DBPP and 29.2%
n-butylmethacrylate polymer, was applied.
This endpoint was evaluated by a limit test in one study (Pounds,
1983). Ten Sprague-Dawley rats, five males and five females, were
exposed during 4 h at a mean nominal concentration of 4.15 mg/l (mist).
No deaths occurred during the exposure or during the 14-day post
exposure period. During the entire study no effects on body weight were
noted. Except for chromodacryorrhea around the nose (5M, 5F) during the
exposure, no other clinical findings were noted. Gross postmortem
findings were normal, except for 2 females with mottled livers.
Two acute dermal toxicity studies were available (Younger, 1956;
Branch, 1979). However, both were ranked with a K4 Klimisch score and
one of them used Acryloid HF-422, a formulation of 70.8% DBPP and 29.2%
n-butylmethacrylate polymer, as a test substance (Branch, 1979). A
weight of evidence approach was applied.
In the oldest study (Younger, 1956), concentrations ranged from
2000 until 7500 mg/kg bw were applied on the intact skin of New Zealand
White rabbits. The minimum lethal dose was found to be in the range of
5000 until 7500 mg/kg bw. Until a dose of 4200 mg/kg bw the animals did
not die but suffered from a slight weight loss (respectively -3.5, -8.0
and -5.0 % for a dose level of 2000, 3200 and 4200 mg/kg bw).
In the other study (Branch, 1979), a limit test was performed with
Acryloid HF-422, a formulation of 70.8% DBPP and 29.2%
n-butylmethacrylate polymer. Five male and five female New Zealand
rabbits were treated with the undiluted test substance. No mortality was
observed at a dose level of 2000 mg/kg bw Acryloid HF-422 (or ≈ 1416
mg/kg bw DBPP). A gross necropsy showed that three animals had necrotic
spots on their livers and that one animal had white sediment in one
kidney. The other six animals did not show remarkable symptoms.
Acute oral toxicity
The test substance has an oral ATE between 2400 and 3000 mg/kg
body weight. According to the CLP Regulation (Annex I, Table 3.1.1),
substances with an oral ATE higher than 2000 mg/kg body weight should
not be classified for Acute toxicity via the oral route.
Acute inhalation toxicity
A limit test for inhalation toxicity was performed at a concentration of
4.15 mg/L (mist). According to the CLP Regulation (Annex I, Table 3.1.1)
an ATE for dusts and mists between 1.0 and 5.0 mg/l should be classified
as Category 4. Because no deaths occurred at 4.15 mg/l it is assumed
that the LD50 will be higher than 5.0 mg/l. Consequently we concluded
that the test substance should not be classified for Acute toxicity via
the inhalation route.
Acute dermal toxicity
The minimum lethal dose was found to be in the range of 5000 to
7500 mg/kg body weight. According to the CLP Regulation (Annex I, Table
3.1.1), substances with an ATE higher than 2000 mg/kg body weight should
not be classified for Acute toxicity via the dermal route.
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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