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EC number: 219-835-9 | CAS number: 2549-53-3
Table: Occurence of statistically significantly increased fetal skeletal variation (expressed as mean percentage of affected fetuses/litter)
Incomplete ossification of parietal; unchanged cartilage
(0.0 – 2.6)
Incomplete ossification of hyoid; cartilage present
(0.0 – 21.6)
Splitting of skull bone
(0.0 – 7.7)
Incomplete ossification of cervical centrum; unchanged cartilage
(0.0 – 9.3)
Supemumerary 13th rib; cartilage not present
(0.0 – 17.5)
Total fetal skeletal variations
(46.3 – 81.9)
HCD = Historical control data; * = p ≤ 0.05, ** = p ≤ 0.01 (Wilcoxon-Test [one-sided])
Table: Total fetal malformations
Table: Total fetal variations
The study was performed according to OECD TG 414 in compliance with GLP.
Methyl Methacrylate was tested for its prenatal developmental toxicity in Himalayan rabbits. The test substance was administered as an aqueous preparation to 25 inseminated female Himalayan rabbits by stomach tube at doses of 50; 150 and 450 mg/kg body weight/day on gestation days (GD) 6 through GD 28. The control group, consisting of 25 females, was dosed with the vehicle (1% Carboxymethylcellulose CB 30.000 in drinking water and a few drops Cremophor EL and one drop hydrochloric acid [1% CMC]) in parallel. A standard dose volume of 10 mL/kg body weight was used for each test group. At terminal sacrifice on GD 29, 24-25 females per group had implantation sites.
The following test substance-related adverse effects/findings were noted:
Test group 3 (450 mg/kg body weight/day):
- Reduced food consumption (-18%) and body weight gain (-31%)
- No test substance-related adverse effects on gestational parameters or fetuses
Test group 2 (150 mg/kg body weight/day):
- Reduced food consumption (-13%) and body weight gain (-27%)
Test group 1 (50 mg/kg body weight/day):
- No test substance-related adverse effects on does, gestational parameters or fetuses
In conclusion, the no observed adverse effect level (NOAEL) for maternal toxicity is nominal 450 mg/kg bw/d (actual 406 mg/kg bw/d), the highest dose tested. The no observed effect level (NOEL) for maternal toxicity is nominal 50 mg/kg bw/d (effective 41 mg/kg bw/d) based on effects on food consumption being a consequence of reduced appetite observed at the LOEL (Lowest Observed Effect Level) of 150 mg/kg bw/d (actual 132 mg/kg bw/d).
The no observed adverse effect level (NOAEL) for prenatal developmental toxicity is nominal 450 mg/kg bw/d (actual 406 mg/kg bw/d). No adverse fetal findings of toxicological relevance were evident at any dose.
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