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: 410-190-0 | CAS number: 132983-41-6
No other concerns identified
There were no clinical signs observed during the study that were related to treatment with
Dietary administration of [test substance], a base oil, to adult male and female F0 and
F1 Crl:CD (SD) rats at dietary levels up to 12000 ppm was not associated with any overt
signs of systemic toxicity, or any effects on reproductive performance.
One F0 female receiving 12000 ppm appeared to complete parturition but showed poor
clinical condition and was killed for welfare reason on Day 1 of lactation. Microscopic
examination of the uterus revealed lesions which were considered to have contributed to the
poor condition of this female and macroscopic examination revealed that parturition had been
incomplete and 5 fetuses were present in utero. Since this was a single incidence of
incomplete parturition among F0 females which was not replicated among F1 females
receiving 12000 ppm this isolated finding was considered to be unrelated to treatment.
There were no effects of treatment on oestrous cycles, pre-coital interval, mating
performance, fertility, gestation lengths and gestation index, offspring organ weights, sperm
motility, concentrations or morphology, for either generation at dietary concentrations up to
12000 ppm of [test substance]. Two F0 females receiving 12000 ppm were observed with total
litter loss, which subsequently resulted in the viability index being marginally lower at this
dose level. This was not considered to be treatment related as it was not replicated in the
F1-F2 generation; where F1 animals have greater exposure to [test substance] compared to that of
the F0 generation. F1 parental animals eat treated diet from a younger age and thus through
more stages of life cycle than F0 parent animals; so if this finding was treatment related, total
litter loss should also have been apparent in F2 litters. There was no effect of treatment on
the ability of the F0 or F1 females to successfully litter and rear their offspring to weaning.
Litter size, survival of the offspring and the offspring sex ratio were not affected by treatment
of either generation.
Bodyweight, bodyweight gain and food consumption for F0 adults were unaffected by
treatment with [test substance]. Among F1males receiving 12000 ppm mean bodyweight gain
during Week 4-5, 7-8 and 9-10 and during Week 7-8 for males receiving 3500 ppm was
marginally but statistically significantly low when compare with Controls. Bodyweight gain
during Weeks 9-10 prior to pairing was statistically significantly lower for F1 females
receiving [test substance], when compared to Controls. However, this had no impact on overall
group mean bodyweight gain prior to pairing or group mean bodyweights. At 12000 ppm,
mean bodyweight gain during Days 0-20 of gestation was marginally but statistically
significantly lower than in Controls; mean bodyweights were significantly lower than
Controls from Day 14 of gestation until Day 14 of lactation, which correlates with the
reduced food consumption at this period; the extent of the overall mean weight loss in the
3500 or 12000 ppm groups was significantly lower than in Controls. These effects on
bodyweight and food consumption were not consistent and not considered adverse as they
had no overall effect on clinical condition, survival or reproductive performance..
had no overall effect on clinical condition, survival or reproductive performance.
Among F2 offspring in the 12000 ppm group, mean body weight gains between Days 1 and
21 were marginally (less than 10%) lower than in Controls. However, this minor effect of
treatment on the growth of the offspring is considered not to be adverse since there was no
effect on the survival or general condition of the offspring.
Absolute and bodyweight relative pituitary weights for F1 adult males receiving 12000 ppm
were marginally but statistically significantly lower than in Controls and bodyweight relative
kidney weights for F1 adult males and females receiving 12000 ppm were marginally but
significantly higher than in Controls. These findings were considered not to be of any
toxicological significance as there were no corresponding macroscopic or histopathological
Macroscopic and histopathological examination of the F0 and F1 adult males and females did
not reveal any findings that were considered to be related to treatment with [test substance].
Macroscopic examination of any abnormal tissues of F1 and F2 offspring did not reveal any
findings that were related to treatment with [test substance] at dietary levels up to 12000 ppm.
The mean ovarian primordial follicle count in the 12000 ppm group was marginally but
statistically significantly lower than in Controls. However, no effect of treatment was
inferred since mean counts were highly variable in each group and review of the individual
values did not reveal any evidence for a treatment related trend to lower follicle counts;
2 control females had atypically high mean follicle counts in excess of 32. The mean number
of implantation in these females was identical to Controls so even if the marginally lower
primordial follicle counts were viewed as treatment related it would not be viewed as an
adverse finding within the context of this study as it did not affect reproductive performance.
The potential for the registered substance to cause reproductive was assessed in two key studies--an OECD 421 reproductive toxicity screening study by dietary route, and an OECD 416 two-generation reproductive toxicity study by dietary route. In both studies, the No Observed Adverse Effect Level (NOAEL) was the highest dose tested, equivalent to approximately 1000 mg/kg/d.
These dataare adequate to conclude the submission substance has a low potential for developmental/reproductive toxicity.
Prenatal developmental toxicity study, 1 key study, NOAEL= 1000 mg/kg/day for rat (OECD TG 414).
The influence of MCP2484 (a base oil) on embryo-fetal survival and development in Crl:CD(SD) rats was assessed following oral administration during and after the organogenesis phase of pregnancy (Days 6-19 after mating). Three groups of twenty female rats received MCP2484 by gavage at doses of 100, 300 or 1000 mg/kg/day from Day 6 to 19 after mating, inclusive. A similarly constituted Control group received the vehicle, corn oil, at the same dose volume throughout the same period. Animals were killed on Day 20 after mating for reproductive assessment and fetal examination. During the study, clinical condition, dosing signs, bodyweight and food consumption were monitored. Adult females were examined macroscopically at necropsy on Day 20 after mating and all fetuses were examined macroscopically at necropsy and subsequently by detailed internal visceral examination or skeletal and cartilaginous examination.
Maternal clinical condition, bodyweight, food consumption and macroscopic evaluation was unaffected by treatment with MCP2484 upto 1000 mg/kg/day when compared with Control animals. Embryo fetal survival growth and external morphology were unaffected by treatment with MCP2484 upto 1000 mg/kg/day.
It was concluded from this study that the dosage of 1000 mg/kg/day was the maternal no observed- adverse-effect-level (NOAEL) and 1000 mg/kg/day was the no-observed-adverse effect- level (NOAEL) for embryo fetal survival and development
The potential for adverse effects on reproduction and in utero development following exposure to the submission substance was evaluated according to the methods described in OECD guideline 414. In this study, three groups of twenty female rats received MCP2484 by gavage at doses of 100, 300 or 1000 mg/kg/day from Day 6 to 19 after mating. A similarly constituted control group received the vehicle, corn oil, at the same dose volume throughout the same period. Animals were killed on Day 20 after mating for reproductive assessment and fetal examination. Maternal clinical condition, bodyweight, food consumption and macroscopic evaluation were unaffected by treatment with MCP2484 up to 1000 mg/kg/day when compared with control animals. Embryo fetal survival, growth, macroscopic pathology, and external morphology (both internal visceral examination and skeletal cartilaginous examination) were unaffected by treatment with MCP2484 up to 1000 mg/kg/day. It was concluded from this study that the dosage of 1000 mg/kg/day was the maternal no observed- adverse-effect-level (NOAEL) and 1000 mg/kg/day was the no-observed-adverse effect- level (NOAEL) for embryo fetal survival and development.
These data are adequate to conclude the submission substance has a low potential for developmental/reproductive toxicity.
There is adequate information available from which to assess the potential of the submission substance to induce reproductive or developmental effects and to conclude that classification underRegulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP), under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations, or under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is not warranted.
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.
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.
Close Do not show this message again