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EC number: 617-116-8
CAS number: 80573-04-2
No treatment related effects were observed on the fertility and mating
performance of male and females rats when examined in two-generation
reproductive toxicity studies at doses of balsalazide disodium of 2000
For general toxicity results, please refer to IUCLID Section 7.5.1 (96
No evidence of developmental toxicity in rats and rabbits was observed
when tested up to dose levels of 2000 mg/kg bw/day and 1200 mg/kg
Due to the apparent effect on the maintenance of pregnancy in females
receiving 600 mg/kg bw/day and above, the sponsor repeared part of the
experiment. In this repeat test three groups were included in which
pregnant rabbits were given oral doses of 0 (vehicle), 300 and 600 mg/kg
from day 6 to 19 of gestation. This experiment had a few problems, such
as older rabbits were used and were not in an active growth phase (even
control rabbits lost their weights during the gestation period). Hence,
no conclusion could be made from this study.
mode of action of toxicity and its relevance to humans has not been
assessed. However, the sodium salt of balsalazide acid has been
authorised for use as a pharmaceutical for the treatment of inflammatory
Increased incidences of bilateral hydronephrosis were seen in the
foetuses of treated groups (low dose – 120 mg/kg bw/day = 0.5%, mid dose
- 600 mg/kg bw/day = 1.2% and high dose - 2000 mg/kg bw/day = 2.2%;
historical control: mean 0.3% and range = 0 - 1.7%) in a fertility and
general reproductive performance study in rats (IUCLID entry REACH 8.7.3
- Center for Drug Evaluation and Research (1997) – rats).
allows the use of limit tests for animal studies (CLP Regulation (EC)
No. 1272/2008 sections 184.108.40.206.7, 220.127.116.11.9) and importantly refers to
the OECD Test Guidelines. In guidelines which are considered relevant
for this endpoint, such as Prenatal Developmental Toxicity Study (OECD
414) and the Two-Generation Reproduction Toxicity (OECD 416), 1000 mg/kg
is specified in both as a limit test in cases where effects are not
expected at that dose. There were no treatment-related biological
effects in the 27 week repeat dose up to 1000 mg/kg. Therefore, in the
reproductive toxicity test, consideration of the effects seen up to the
1000 mg/kg (mid-dose) must be seen together with the historical control
data. Specifically, the effect up to 1000 mg/kg was within the
historical control range and not considered significant enough to
trigger classification. Any effect seen at doses higher than this are
not considered relevant for classification, as they are unnecessarily
high and significantly above any expected human exposure. In addition
the FDA concluded in 2000, that there is no significant evidence of
reproductive toxicity of Balsalazide disodium salt, thus further
supporting the argument that no classification is needed.
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