Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 220-020-5
CAS number: 2605-79-0
One-hundred Crl:CDBR VAF/Plus presumed pregnant female rats were
randomly assigned to four dosage groups (Groups 1 through IV), 25 rats
per group. The test substance preparations for dosing were corrected for
purity. The test substance, was administered orally (via gavage) once
daily to these female rats on days 6 through 19 of presumed gestation
(DGs 6 through 19), at dosages of 0 (Vehicle), 25, 100, and 200 mg alkyl
dimethyl amine oxide/kg/day. The dosage volume was 5 mL/kg, adjusted
daily on the basis of the individual body weights recorded before
intubation. The rats were intubated at approximately the same time each
The rats were observed for viability at least twice a day and for
general appearance weekly during acclimation and on DG 0. The rats were
also examined for clinical observations of effects of the test
substance, abortions, premature deliveries and deaths immediately before
and approximately 60 minutes after dosage and on the day of sacrifice
(DG 20). Body weights were recorded weekly during acclimation, on DG 0,
daily during the dosage period and on DG 20. Feed consumption values
were recorded on DGs 0, 6, 9, 12, 15, 18, and 20.
All surviving rats were sacrificed on DG 20, and a gross necropsy of the
thoracic, abdominal and pelvic viscera was performed.
Caesarean-sectioning and subsequent fetal observations were conducted
without knowledge of dosage group in order to minimize bias. The number
of corpora lutea in each ovary was recorded. The uterus of each rat was
excised and examined for pregnancy, number and distribution of
implantations, live and dead fetuses and early and late resorptions. The
gravid uterus was weighed. Each fetus was removed from the uterus and
subsequently weighed and examined for sex and gross external
alterations. Approximately one-half of the fetuses in each litter were
examined for soft tissue alterations using a variation of the
microdissection techniques. The remaining fetuses in each litter were
examined for skeletal alterations.
Two rats in the 200 mg/kg/day dosage group died; one of these deaths was
attributed to the test substance, the other was the result of an
intubation error. All other rats survived until scheduled sacrifice.
Excessive salivation, rales, urine-stained abdominal fur, brown or red
perioral substance, labored breathing and gasping occurred in 100
mg/kg/day dosage group rats and in significantly increased numbers of
200 mg/kg/day dosage group rats. Additionally, chromorhinorrhea occurred
in one and two rats in these two dosage groups, respectively.
Observations of brown or red perivaginal substance, emaciation, brown
perianal or perinasal substance, dehydration, ungroomed coat and soft or
liquid feces occurred in one or two rats in the 200 mg/kg/day dosage
group. All necropsy observations were considered unrelated to the test
Rats in the 100 and 200 mg/kg/day dosage groups had significantly
reduced body weight gains for the entire dosage period (calculated as
days 6 to 20 of gestation) and body weight gains were significantly
reduced in the 200 mg/kg/day dosage group for the entire gestation
period (DGs 0 to 20). Body weights were significantly reduced in the 200
mg/kg/day dosage group on DGs 11 through 20. The gravid uterine weight
and the corrected DG 20 maternal body weight (DG 20 body weight minus
the gravid uterine weight) were significantly reduced in the 200
mg/kg/day dosage group.
Absolute (g/day) and relative (g/kg/day) feed consumption values for the
entire dosage period (calculated as DGs 6 to 20) and the entire
gestation period (DGs 0 to 20) were significantly reduced in the 200
mg/kg/day dosage group. Relative feed consumption values for the entire
dosage period were also significantly reduced in the 100 mg/kg/day
dosage group, while values for the gestation period were significantly
reduced in the 25, 100 and 200 mg/kg/day dosage groups.
Male and female fetal body weights were significantly reduced in the 200
mg/kg/day dosage group. Live litter size was decreased and the number of
early resorptions was increased in the 200 mg/kg/day dosage group, but
apparently as the result of one dam in this dosage group that had a
litter consisting of 16 early resorptions.
The percentages of fetuses and litters with alterations in the 200
mg/kg/day dosage group were significantly increased and reflected delays
in skeletal ossification related to the significantly reduced fetal body
weights in this group. These delays in ossification included significant
increases in the fetal and/or litter incidences of bifid thoracic
vertebrae centra, incompletely and/or not ossified 1st or 2nd sternal
centra, incompletely ossified pubes and significant decreases in the
numbers of ossified caudal vertebrae, sternal centers and metacarpals.
Additionally, delays in ossification occurred in the 100 mg/kg/day
dosage group and included a significant increase in the litter incidence
of bifid thoracic vertebrae centra.
NOAEL for both maternal toxicity and developmental toxicity is 25
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.
Tato webová stránka používá cookies, aby se vám naše stránky používaly co nejlépe.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again