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EC number: 204-210-5
CAS number: 117-80-6
Due to lack of repeated dose toxicity data by the inhalation route, a
route to route extrapolation was performed. The NOAEL (oral) is
converted into a NOAEC (corrected) in accordance to guidance on
information requirements and chemical safety assessment, Chapter R.8,
ECHA, May 2008. The NOAEL (oral) has to be divided by a factor of 0.38
m³/kg body weight and corrected for activity driven differences of
respiratory volumes in workers compared to workers in rest (6.7 m³/10
m³). In addition, a default factor of 2 is applied to account for
differences in oral and inhalative absorption properties.
The corrected starting point is therefore:
NOAEC (corrected) = 50 mg/kg / 0.38 m³/kg x (6.7 m³/10m³) x 0.5 = 44.1
The dermal route is typically covered by oral route information in the
absence of data for this administration route. Since no data on
penetration through skin are available, absorption of 100% is assumed.
A combined repeated dose toxicity study with the reproduction screening
is available for the test article. The effects cause by the test
substance are mainly due to local irritation in the stomach. In
addition, adaptive weight increases in the kidney are reported, however
without histological findings in males. In females there are
histological findings in the kidney, but their correlation and
toxicological relevance are questionable. Therefore, since no conclusive
systemic toxicity is reported up to the highest dose level of 50 mg/kg,
this value was used for risk assessment of systemic effects. The
irritation potential is addressed separately by a qualitative approach.
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