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EC number: 417-790-1
CAS number: 78418-01-6
10 mg/kg bw/day
30 mg/kg bw/day
100 mg/kg bw/day
Pairs started (N)
Mated Females (N)
Mean days of pairing before mating
Conceiving days 1-5 (N)
Conceiving days 6-14(N)
Conceiving day unknown (N)*
Females achieving Pregnancy (N)
Pregnancy ≤ 21 days (N)
Pregnancy = 22 days (N)
Pregnancy ≥ 22 days (N)
Pregnancy unknown duration (N)*
Dams with live young born (N)
Dams with live young born at Day 4 (N)
One female did not show evidence of mating but achieved pregnancy and
delivered live pups.
of the offspring findings
Total number of live pups delivered
Live birth index (%)
Mean sex ratio
Total number of live pups
In a reproduction/developmental toxicity
screening study performed according to OECD Guideline 421 and in
compliance with GLP, Mexoryl SAB was administered by oral gavage to
groups (10/sex/dose) of Wistar Hannover rats at the dose levels of 0,
10, 30 and 100 mg/kg bw/day as a solution in the vehicle (PEG300) with
the dose volume of 4 mL/kg bw/day, for 2 weeks before mating, during
mating, gestation and until day 4 post-partum for the females, and for 2
weeks before mating, during mating and 22-35 days after the last day of
mating for males. Mortality, clinical signs, body weight change, food
consumption, reproductive performance, organ weights, macroscopic and
microscopic examination were examined in parental animals. The pups were
observed daily for clinical signs, sexed and weighed on Days 0 and 4
post partum and sacrificed on Day 4 post partum and subjected for
No mortality and no clinical signs
attributed to treatment with the test item were observed. No effects on
body weight or food consumption were observed. The reproductive
performance of males and females, mating, fertility, gestation and live
birth indices were similar to that of the control group. No
treatment-related effects were noted on weights of testes, epididymides,
ovaries, uterus and cervix and no treatment-related findings were
recorded at necropsy or microscopic examination. The test item treatment
had no effects on the clinical condition of the pups, body weight or sex
ratio. No macroscopic findings were observed in the pups sacrificed on
Day 4 post-partum.
Under the test conditions, the No Observed
Effect Level (NOEL) of Mexoryl SAB was considered to be 100 mg/kg bw/day
for parental toxicity, embryo-fetal developmental toxicity and pup
development until Day 4 post-partum in Wistar Hannover rats.
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