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EC number: 939-707-2
CAS number: -
a repeated dose inhalation toxicity study according to OECD Guideline
412 (1990), groups of male and female Wistar rats (5/sex) were exposed
by the inhalation route to the test substance as dust aerosol for 6
hours per day on 5 days per week for 4 weeks (28-day test) to head/nose
at concentrations of 0, 0.8, 8, 80 mg/m³ (nominal concentrations) or 0,
0.86, 8.1, 82 mg/m³ (analytical concentrations). Groups of 5 female rats
were hold without further exposure for an about 4-week post-exposure
observation period to obtain informations on persistency, progression or
regression of effects.
mortality and no clinical signs were reported throughout the study
whatever the dose level. Body weight gain was reduced in high dose males
only. There were no test item-related effects on hematology and clinical
chemistry parameters at any dose levels. No macroscopic findings were
reported at necropsy. An increase of absolute and relative lung weights
in male animals was observed at 82 mg/m³ and in female animals at 8.1
and 82 mg/m³. Histopathologically, goblet cell hyperplasia was reported
in the bronchi of both sexes at 82 mg/m³. Furthermore, the grade of
severity of pneumonitis that occurred also in control animals was
slightly increased in the animals at 82 mg/m³, as was there a slight
increase in the content of connective tissue of the lungs. In the nasal
cavity, focal metaplasia of the respiratory epithelium to stratifying
epithelium was noted in the animals at 82 mg/m³ at the transition of the
stratifying epithelium to respiratory epithelium. After a 4-week
recovery period (females only), the lungs of the animals at 82 mg/m³
showed only a slight reparative increase of mature connective tissue.
Focal metaplasia in the nasal cavity was evident in only 2 animals at 82
on the results of this study, 82 mg/m³ of test item was established as
the No Observed Adverse Effect Level (NOAEL) systemic based
on the absence of toxicologically significant systemic effects; 0,86 mg/m³
of test item was established as the No Observed Adverse Effect Level
(NOAEL) local and 8.1 mg/m³ of test item was established as the Lowest
Observed Adverse Effect Level (LOAEL) local based on the effects
on lung weight.
reaction product of naphthalene, butanol, sulfonated and neutralized by
caustic soda is not classified for repeated dose toxicity according to
the classification criteria of the Regulation (EC) 1272/2008 (CLP) and
of the Directive 67/548/EEC.
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