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EC number: 201-297-1
CAS number: 80-62-6
The various analyses:
Nominal Dose(mg/kg bw/d)
Analytical Dose(mg/kg bw/d)[minimum]
Analytical Dose (mg/kg bw/d)[maximum]
% Nominal Dose[minimum]
% Nominal Dose[maximum]
00 / 10
01 / 11
02 / 12
03 / 13
The study was performed according to OECD TG 416 in compliance with GLP.
Methyl Methacrylate was administered to groups of 25 male and 25 female
healthy young Wistar rats (P parental generation) as an aqueous
preparation by stomach tube at dosages of 0; 50; 150 and 400 mg/kg body
weight/day. At least 73 days after the beginning of treatment, P animals
were mated to produce a litter (F1). Mating pairs were from the same
dose group and F1 animals selected for breeding were continued in the
same dose group as their parents. Groups of 25 males and 25 females,
selected from F1 pups to become F1 parental generation, were treated
with the test substance at dosages of 0; 50; 150 and 400 mg/kg body
weight/day post weaning, and the breeding program was repeated to
produce F2 litter. The study was terminated with the terminal sacrifice
of the F2 weanlings and F1 adult animals.
Control parental animals were dosed daily with the vehicle (1%
Carboxymethylcellulose suspension in drinking water and four drops
Cremophor EL and one drop hydrochloric acid).
The mid- and high-dose parental animals (400 mg/kg bw/d) showed clinical
signs of systemic toxicity. The only relevant clinical observation was
temporary salivation during a short period after dosing, which is
considered to be test substance-induced. From the temporary, short
appearance immediately after dosing it is likely, that this finding was
induced by a bad taste of the test substance or local affection of the
upper digestive tract. It is, however, not considered to be an adverse
toxicologically relevant finding.
In the mid- and high-dose (150 and 400 mg/kg bw/d) P generation animals,
dose-related intermittent reductions of food consumption were noted,
either during premating, gestation and lactation phases of this study.
Less significant changes were noted for the F1 generation animals where
the effects were limited to the high-dose group.
High dose F1 parental males had statistically significant lower body
weights during several study segments, which led to a statistically
significant reduction of the mean terminal body weight resulting in
secondary weight changes of brain.
High dose parental females had statistically significant lower body
weights during the first weeks after weaning. This weight decrease
during major phases of sexual maturation led to an apparent marginal
delay of vaginal patency. This minor delay did, however, not result in
any corroborative pathological findings nor did it adversly effect F1
female cyclicity, fertility and reproduction. Thus, an influence of the
test substance on female sexual maturation is not assumed.
Pathological examinations revealed no test-substance-related changes in
organ weights, gross lesions, changes in differential ovarian follicle
counts or microscopic findings, apart from an increase in kidney and
liver weights in male and female animals in both generations which is
presumably related to the treatment. There was no histopathologic lesion
observed, that could explain the weight increase. It is regarded to be
an adaptive change, most likely caused by an increase in metabolic
activity in the two organs, which does not lead to histopathologic
findings. It is not regarded to be an adverse effect.
There were no indications from clinical examinations as well as gross
and histopathology, that the administration of methyl methacrylate via
the diet adversely affected the fertility or reproductive performance of
the P or F1 parental animals up to and including a dose of 400 mg/kg
bw/day. Estrous cycle data, mating behavior, conception, gestation,
parturition, lactation and weaning as well as sperm parameters, sexual
organ weights and gross and histopathological findings of these organs
(including differential ovarian follicle counts in the F1 females) were
comparable between the rats of all test groups and ranged within the
historical control data of the test facility.
All data recorded during gestation and lactation in terms of
embryo-/fetal and pup development gave no indications for any
developmental toxicity in the F1 and F2 offspring up to a dose level of
400 mg/kg bw/day. Up to this dose level, the test substance did not
adversely influence pup viability and pup body weights. Sex ratio and
sexual maturation was not directly affected at any dose level, inclusive
the high-dose group (400 mg/kg bw/day).
conditions of the present 2-generation reproduction toxicity study the NOAEL(no
observed adverse effect level) forgeneral,
400 mg/kg bw/d for the parental rats, the highest dose tested.
observed effect level) is 50 mg/kg bw/d for the F1 parental rats 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 in
the F0 parental females.
the F1 parental rats is 400 mg/kg bw/d, the highest dose tested.
in the F1 of the test substance is 400 mg/kg bw/d, the highest dose
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