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EC number: 203-782-3
CAS number: 110-60-1
The majority of animals were unremarkable. There were no lesions of any
unusual nature or incidence to suggest any gross toxic effect.
The respiratory tract of control animals was generally unremarkable
apart from occasional foci of foamy histiocyte accumulation or
pneumonitis. Histopathology findings in the other tissues examined were
generally infrequent or of a minor nature such as foci of leucocyte
accumulation in the liver.
There wer treatment-related effects in the anterior nasal cavity of
group 4 rats.These consisted of low grade hyperplasia of the epithelial
lining of the lateral wall and turbinates, and atrophy of the most
anterior portions of the olfactory epithelium. These findings are
indicative of low grade irritation of the anterior nasal cavity.
Occasional rats also showed minor extensions of olfactory epithelial
atrophy into the mid-dorsal nasal cavity. In general, however, the
posterior nasal cavity, conducting airways and lung parenchyma resembled
that of control rats. Minimal changes were also found in the respiratory
epithelium of the anterior nasal cavity of some rats in group 3, but no
changes were seen in group 2 rats.
There were no unusual findings in the other organs and tissues examined
to suggest any systemic toxicity as a result of test article
This study was performed to evaluate the toxicity of 1,4 butane diamine
when repeatedly administered to the rat by inhalation for 2x2 hours each
day, 5 days/week for 4 weeks.
Groups of Sprague-Dawly rats, comprising 5 animals of each sex were
exposed at target dose levels of 0, 0.01, 0.05, 0.25 mg/l. These were
groups 1, 2, 3 and 4 respectively.
A dose level of 0.011 mg/l (=11 mg/m3) was identified as the NOEL (No
Observed Effect Level)
There were no deaths during the course of this study.
There were no signs that could be unequivocally attributed to treatment.
The body weight gains of treated animals were similar to those of the
The food consumption of the treated animals was similar to those of the
No treatment-related ophthalmic defects were found.
There were no changed in the haematological parameters that could be
attributed to treatment.
There were no lesions of any unusual nature or incidence to suggest any
gross toxic effect.
The organ weights of treated animals were similar to those of the
Histopathologically, a treatment-related low grade irritation of the
anterior nasal cavity of high and intermediate dose group animals only
There were no organ or tissue changes to suggest any systemic toxicity.
The exposure chamber temperature recorded for the control and treated
groups ranged between 15 and 20°C, and the humidity between 28 and 90%.
The exposure chamber flow rate for the control and treated groups ranged
between 8 and 16 litres/min.
The exposure chamber oxygen concentration for the control and treated
groups ranged between 21 and 22%.
The overall mean measured concentrations were 0.011, 0.05, and 0.27 mg/l
for groups 2, 3 and 4 respectively.
The mean mass median aerodynamic diameters for the treated groups were
1,92, 2,57 and 3.00 µm for groups 2, 3, and 4 respectively. All values
were below the upper respirable limit of 8 µm.
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