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EC number: 268-692-9
CAS number: 68133-60-8
OECD 422: NOAEL = 1000 mg/kg bw/day (WIL Research Europe, 2013)
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.
14-Day dose range finding study for a Combined Repeated Dose
Toxicity Study with the Reproduction/Developmental toxicity Screening
Test of LUGALVAN BPC DRY in rats by oral gavage (WIL Research Europe,
No guidelines are applicable as this pilot study was used to
select dose levels for the Combined Repeated Dose Toxicity Study with
the Developmental/Repro Screening Test of LUGALVAN BPC DRY
Rationale for dose levels
No clinical signs or deaths were observed after single
administration of a 34% aqueous solution of the test compound at the
dose level of 2000 mg/kg bw in rats (information provided by the
sponsor). Based on this information, the dose levels of 0, 300 and 1000
mg/kg bw/day were selected for the present study.
After acclimatization, three groups of four male and four female
Wistar Han rats were exposed by oral gavage to the test substance at 300
and 1000 mg/kg bw/day. Animals of the control group received the
vehicle, water, alone.
The following parameters were evaluated: mortality / viability,
clinical signs, body weights, food consumption, clinical laboratory
investigations, macroscopy, and organ weights. Formulations were
analyzed once during the study to assess accuracy, homogeneity and
Accuracy, homogeneity and stability of formulations were
demonstrated by analyses.
Effects at 1000 mg/kg bw/day consisted of a slight body weight
loss on Day 10 of study for the females, reduced urea (both sexes) and
inorganic phosphate (females) levels, increased kidneys weight for one
male, and decreased spleen weights for all males.
In addition, lower inorganic phosphate concentrations were also
noted for females at 300 mg/kg bw/day.
Treatment with LUGALVAN BPC DRY by oral gavage in male and female
Wistar Han rats at dose levels of 300 and 1000 mg/kg body weight/day
revealed slight effects at 1000 mg/kg body weight/day. Based on the
results of this range finding study, dose levels for the Combined
Repeated Dose Toxicity Study with the Developmental/Repro Screening Test
of LUGALVAN BPC DRY (85R0642/12X354) were: 100, 300 and 1000 mg/kg
bw/day. As no clinical signs were observed, clinical observations and
functional observational tests for the main study (85R0642/12X354) were
conducted at least immediately after dosing.
Based on the available data, the test
substance is not classified with regard to repeated dose toxicity
according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008
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