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EC number: -
CAS number: -
A formulation of the substance was tested in an acute oral test (limit
test at 5000 mL/kg). One of ten animals died. The outcome was an LD50 of
>5000 mL/kg, when corrected for purity 2150 mg/kg bw.
For inhalation toxicity an invalid study on a formulation of the
substance was available. As the inhalation route is considered not very
relevant for exposure this study is not further taken into account.
Dermal toxicity was evaluated for AMP (LD50 >2000 mg/kg bw), but not for
PTSA in view of the corrosive effects of this acid. As the substance is
a salt of PTSA corrosion is not expected. In view of the outcome of the
acute oral toxicity study on the formulation of the study, it is
expected that the substance is of low demal toxicity.
The substance (formulation) was tested for acute toxicity in 10 male
rats at 5 mL/kg bw. No mortality or signs of toxicity were observed
during the 14 -day observation period. The LD50 is >2150 mg/kg bw when
corrected for purity.
P-1826 (AMP, 2-amino-2-methyl-l-proano1) was tested for acute dermal
toxicity using 12 rabbits. The Rabbits were split into 3 groups of 4.
All rabbits had their abdomens shaved free of hair, 2 animals in each
group also had their skin abraded using a blunt hypodermic needle. The
test material was applied at doses of 1000, 1500 or 2000 mg/kg bw under
an occluded dressing for 24 hours. After the exposure period the rabbits
were observed for a further 14 days. Following this first test an
additional 8 rabbits were used. The abdomen of each rabbit was shaved
and then abraded using a blunt hypodermic needle. These rabbits were
exposed for 24 hours to 2000 mg/kg bw AMP and then followed for a
further 14 days. A t the end of 24 hr exposure, the intact andabraded
treated skin sites were severely irritated and black in color. The sites
became necrotic within two to three days and remained necrotic for the 1
4 days. The treated sites had severe eschar forrnation by the 14th day,
The rabbits in the three treatment groups lost body weight over the
two-week observation period. The animals in all the treated groups
showed no signs of toxicity or abnormal pharmacological behavior. At
necropsy the organs in all rabbits were grossly normal. The treated skin
sites in all the rabbits were necrotic. In conclusion, AMP was dermally
nontoxic (LD50 > 2000 mg/kg), but was a severe skin irritant.
Based on the considerations above the substance is not to be classified
for acute toxicity according to (EC) No 1272/2008 (CLP).
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