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EC number: 219-956-7
CAS number: 2582-30-1
A reproduction/ developmental toxicity screening test was carried out in
order to assess the test material in accordance with the standardised
guidelines OECD 421 and EPA OPPTS 870.3550 under CLP conditions.
Four groups of ten male and female Wistar Han rats were exposed by oral
gavage to the test material at 0, 88, 300 and 1000 mg/kg bw/day in
carboxymethylcellulose. Males were exposed for 28 days
( 2 weeks prior to mating, during mating, and up to termination) and
females were exposed for up to 55 days ( 2 weeks prior to mating, during
mating and gestation and during at least 4 days of lactation).
Animals were evaluated for mortality/ viability, clinical and functional
observations, body weights and food consumption, clinical pathology,
macroscopy at termination, organ weights and histopathology on a
selection of tissues.
No clinical signs directly related to the test item were observed in any
Under the conditions of this study, the NOAEL for general systemic
toxicity was 300 mg/kg bw/day in males based on decreased food
consumption and body weights/ body weight change at 1000 mg/kg bw/day. For
females the NOAEL was 88 mg/kg bw/day as they showed decreased absolute
and relative thymus weights at 300 mg/kg bw/day. There was
reduced cellularity in the thymus of females at 1000 mg/kg bw/day only.
At 1000 mg/kg bw/day, there were also signs of chronic nephropathy and
hypertrophy of the kidney tubules as well as hepatocellular hypertrophy
in female animals only.
In a second 28 day study following OECD guideline, Wistar rats
were exposed to 0, 100, 300, and 1000 mg/kg bw/day of the test
substance. Animals were evaluated for mortality/ viability,
clinical and functional observations, body weights and food consumption,
clinical pathology, macroscopy at termination, organ weights and
histopathology on a selection of tissues. The only effects were reduced
body weight likely due to reduced food intake as well as an increase in
alkaline phosphatase in the high dose group, but no histological effects
were found. The NOAEL for this study was 1000 mg/kg bw/day.
Based on the available data no classification or labelling is required.
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