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EC number: 268-692-9
CAS number: 68133-60-8
A combined 28-day repeated dose toxicity study with the
reproduction/developmental toxicity screening test of LUGALVAN BPC DRY
was conducted in rats by oral gavage according to OECD 422 guideline and
GLP (WIL Research Europe, 2013).
Rationale for dose levels
Based on the results of the dose range finding study (Project 501951;
BASF Project 01R0642/12X355) dose levels for this combined 28-day oral
gavage study with reproduction/developmental toxicity screening test
were 100, 300 and 1000 mg/kg bw/day.
After acclimatization, four groups of ten male and ten female Wistar Han
rats were exposed by oral gavage to the test substance at 0, 100, 300
and 1000 mg/kg bw/day.
Males were exposed for 29 days, i.e. 2 weeks prior to mating, during
mating, and up to termination.
Females were exposed for 44-49 days, i.e. during 2 weeks prior to
mating, during mating, during postcoitum, and during at least 4 days of
The following observations and examinations were evaluated: mortality /
viability, clinical signs (daily), functional observations and locomotor
activity (end of treatment), body weight and food consumption (at least
at weekly intervals), clinical pathology (end of treatment), macroscopy
at termination, organ weights and histopathology on a selection of
tissues, and reproduction/developmental parameters, consisting of
mating, fertility and conception indices, precoital time, number of
corpora lutea and implantation sites, gestation index and duration,
parturition, maternal care, sex ratio and early postnatal pup
development (mortality, clinical signs, body weights and macroscopy).
Formulations were analyzed once during the study to assess accuracy,
homogeneity and stability.
Accuracy, homogeneity and stability of formulations were demonstrated by
No parental toxicity was observed up to the highest dose level tested
(1000 mg/kg bw/day).
No reproductive toxicity was observed up to the highest dose level
tested (1000 mg/kg bw/day).
No developmental toxicity was observed up to the highest dose level
tested (1000 mg/kg bw/day).
Treatment with LUGALVAN BPC dry by oral gavage in male and female Wistar
Han rats at dose levels of 100, 300 and 1000 mg/kg bw/day revealed no
parental, reproductive or developmental toxicity up to 1000 mg/kg
bw/day. Based on these results, a parental, reproduction and
developmental No Observed Adverse Effect Level (NOAEL) of at least 1000
mg/kg was derived.
Based on the available data, the test
substance is not classified with regard to toxicity to reproduction
according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008
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