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EC number: 242-060-2
CAS number: 18172-67-3
Table 1 - Mean body weight gain (g) in males
Table 2 - Mean body weight gain (g) in
In a 90-day inhalation study conducted by
NTP similarly to OECD guideline 413, groups of 10 animals per dose and
per sex were administered for 6 hours per day, 5 weekdays per week at 0,
25, 50, 100, 200 and 400 ppm for a total of 14 weeks. The animals were
observed twice per day and weighed once per week. A complete
histopathologic evaluation including treatment-related gross lesions was
performed on all animals, including early death animals.
Treatment-related lesions (target organs) were identified and these
organs and gross lesions were examined to a no-effect level.
Apart from lesions including granular casts
and hyaline droplets indicative of alpha2µ-globulin nephropathy observed
in all treated group males, a lower body weight gain than in controls
was observed in the high dose group in both sexes. In addition, 6
females died and 3 females displayed mild tremors in the high dose group
The LOAEL in male rats is the lowest dose
level tested, but it is not relevant to humans as it is based on renal
effects linked to alpha2µ-globulin accumulation. When considering
effects other than those on kidneys in males, a lower body weight gain
was observed at 400 ppm when compared to controls. A NOAEL could be
defined in female rats at 200 ppm on the basis of mortality and a lower
body weight gain at the next dose level when compared to controls. Mortality
was observed in female rats in the high dose group. As no specific
target organ was sufficiently impaired by the treatment to cause
mortality, it may be concluded that these deaths have a general systemic
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