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EC number: 476-160-4
CAS number: 54807-34-0
Two generation reproduction toxicity in CD
rats - Neeper-Bradley (1994)
In conclusion, continuous exposure to DMH in
the diet for two generations did not result in parental toxicity or
adverse effects on reproduction or reproductive tissues at dietary
concentrations as high as 20000 ppm. Small increases in parental food
consumption and body weight and slight transient decreases in offspring
body weight were observed at the 20000 ppm dose level. The
no-observed-effect level (NOEL) for parental animals and offspring in
this study was 6000 ppm. The NOEL for reproductive effects was at least
The substance is not a developmental toxin as no maternal toxic effects and no teratogenic/embryotoxic effects were observed.
Table 1. Results for maternal effects
100 mg/kg bw/d
300 mg/kg bw/d
1000 mg/kg bw/d
Number of dams examined
Mortality of dams (%)
Body weight gain (mean (g))
Days 15-21 (post treatment)
Days 0 -21 (gestation)
Food consumption (mean (g))
Day 0 to 6 (pre-treatment)
Day 6 to 15 (treatment)
Day 15 to 21 (post treatment)
Table 2. Results for teratogenic effects:
litter response (Caesarean section data)
0 mg/kg bw/d
Corpora lutea (mean)
Early Resorptions (mean)
Late Resorptions (mean)
Live fetuses (%)
Dead fetuses (%)
pre-implantation loss (state %)
fetus weight (mean) [g]
Fetal sex ratio [% male fetuses]
Table 3: Examination of the fetuses
0 mg/kg bw/d
Soft tissue malformations*[%]
Soft tissue variations*[%]
This study has been performed on DMH (Dimethyl Hydantoin)
and has been used for read-across purposes. The
substance is not a developmental toxin as no maternal toxic effects and
no teratogenic/embryotoxic effects were observed.
Test substance DMH was estimated of not
displaying any developmental toxicity effects or teratogenic/embryotoxic
effects in all three developmental studies.
In a two generation reproductive toxicity
study the no-observed-effect level (NOEL) for parental animals and
offspring in this study was 6000 ppm. The NOEL for reproductive effects
was at least 20000 ppm.
Developmental toxicity effects or
teratogenic/embryotoxic effects were not recorded in any of the three
developmental toxicity studies.
As previously stated these studies have been
performed on DMH (Dimethyl Hydantoin) and have been used for read-across
purposes. A summary of data for read-across of NaDMH with DMH is given
in Section 13.
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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