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EC number: 908-205-5
CAS number: -
Reproductive-Developmental screen results for category member FC-770
(PIPM, CAS# 1093615-61-2) are reported for read-across to the category
Perfluorinated Organic Chemicals, C5-C18. This study evaluated the
potential reproduction and/or development effects following treatment
with the test article in Sprague Dawley rats. This study was performed
in compliance with OECD GLP. The test method was based on OECD 421. The
test article was diluted in a vehicle composed of 0.5% Natrosol 250HX
and 0.1% Tween 80 in Water for Irrigation. Rats (10/sex/group) received
vehicle, 100, 500, or 1000 mg/kg-day of the test article via oral
gavage. Males were dosed once daily for 4 weeks overall, commencing 2
weeks prior to mating. Females were dosed once daily from 2 weeks prior
to mating and then continued until at least Day 4 of lactation. Females
were euthanized with their litters between Days 5 and 6 of lactation.
Parameters evaluated: Clinical observations (daily); body weights
(weekly and Days 0, 7, 14, 16, 20 of gestation and Days 1 and 4 of
lactation for females); food consumption (weekly and Days 0-4 of
lactation for females); litter live/dead evaluation (Day 0 of
lactation); necropsy; ovary and testis weights; histopathology of ovary,
epididymis, and testis of control and 1000 mg/kg-day animals.
Reproductive indices were calculated. Pups were examined for external
abnormalities. Externally normal pups were discarded at necropsy.
Externally abnormal pups were fixed in formalin for possible future
analysis. In treated females prior to mating, there was a slight
reduction in group mean body weight gains and food consumption over the
first two weeks of treatment, compared with control; these reductions
achieved statistical significance in animals treated at 500 and 1000
mg/kg-day. However, absolute body weights and food consumption of the
females was also slightly lower than control prior to the treatment
period, and therefore this slight reduction that persisted from
commencement of treatment was not likely attributed to treatment. Group
mean body weight gains and food consumption in the males throughout the
study, and for females during gestation and lactation were similar to
control. Mating performance, fertility, duration of gestation, litter
size and survival, and litter and pup weights did not indicate any
obvious effect of treatment at any of the dose levels tested. Based on
the results of this study, the no observed effect level (NOEL) for
adults and for reproductive parameters was considered to be 1000
mg/kg-day. By read-across, the target substance is also considered to
have a NOEL of 1000 mg/kg-day.
Because these substances exhibit similarity in their physicochemical
properties and toxicological properties in mammals, and because
available data indicates that parent molecules are not reactive toward
biological molecules and cannot undergo bioactivation by normal
enzymatic processes, they can be considered to constitute a chemical
category. Data gaps for partitioning properties, mammalian and
ecological toxicity can therefore be addressed by read-across and/or
trend analysis between category members. The readacross is considered
reliable with restrictions and the result is suitable for use in Risk
Assessment, Classification & Labelling, and PBT Analysis.
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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