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EC number: 946-138-3
CAS number: -
The objective of this study was to
provide data on the possible effects of the test substance
DTPA-FeNaH on reproductive performance of Wistar rats and the
development of pups following daily oral administration at
concentrations of 0, 150, 500 or 1500 mg/kg bw of the test
substance by gavage to male and female rats during a pre-mating
period of 10 weeks, during mating (16 days), and during gestation
and lactation until postnatal Day 4 (PN Day 4); see also section
7.5.1 and 7.8.2.
The homogeneity and content of the
test substance in the gavage solutions were confirmed by analysis.
Males and females of the high-dose
group showed soft faeces in various weeks of the premating period.
Daily clinical observations during the gestation and lactation
period did not reveal any treatment-related changes in the
animal’s appearance, general condition or behaviour. Mean body
weights were decreased in males of the high-dose group from week 5
onwards. There were no treatment-related effects on female body
weights during the entire study. No treatment-related effects were
observed on food consumption of male and female animals during the
No treatment-related effects were
observed on pre-coital time, mating index, female fecundity index,
male and female fertility indices, duration of gestation, number
of animals that delivered liveborn pups, number of corpora lutea,
number of implantation sites, pre-implantation loss or viability
index. Decreased epididymal sperm motility, decreased weight of
the cauda epididymides and decreased epididymal sperm reserve were
observed in males of the high-dose group. No changes were observed
in epididymal sperm morphology, or the weight of testicular
parenchyma, the number of spermatozoa per gram testicular
parenchyma or on the daily sperm production. The relative weights
of the kidneys and liver were increased in both sexes of the
high-dose group. The relative weight of the epididymides was
decreased in males of the high-dose group. Macroscopic examination
at necropsy, microscopic examination of organs and tissues did not
reveal any treatment-related changes
Based on the results of this study,
viz. soft faeces (both sexes), decreased body weight gain (males),
prolonged prothrombin time (males), increased haemoglobin
concentration (males), decreased ALAT activity and chloride
concentration (males) and increased relative weights of kidneys
and liver (both sexes) as observed in animals treated with the
highest concentration of the test substance, the No Observed
Adverse Effect Level (NOAEL) for parental toxicity is 500 mg/kg
body weight/day. Based on the results of this study, viz. a
decrease in sperm motility, cauda epididymis weight and in sperm
reserve, as observed in male animals treated with the highest
concentration of the test substance, the No Observed Adverse
Effect Level (NOAEL) for fertility is 500 mg/kg body weight/day.
Based on the results of this study, which did not show any
toxicological effects of the test substance on development, the No
Observed Adverse Effect Level (NOAEL) for developmental toxicity
is ≥1500 mg/kg body weight/day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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