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EC number: 201-204-4
CAS number: 79-41-4
Regarding fertility, there is screening-level information on MAA
(90 d inhalation study). Sufficient data to address all reproductive
endpoint can be obtained by read-across from a 2-generation reproductive
toxicity study on MMA by the oral route. No further testing is proposed.
In a OECD 413 90-day inhalation study 10 male and 10 female
Sprague Dawley rats were whole body exposed to target concentrations of
20, 40, 100 and 350 ppm (corresponding to 72, 143, 358 and 1253 mg/m3)
MAA for 6 hrs/d, 5 days/wk for 90 days (65 exposures; BASF 2008). In
addition to examination of the standard organs and tissues, the sexual
organs and parameters of fertility were examined. These examinations
included weighing of sexual organs in both males and females and sperm
mobility, morphology and sperm head count in one testis and one
epididymis of each male animal of the high concentration and control
group. Substance-related changes of the sexual organs were not noted in
any of the exposed animals (males or females), nor were there any
changes of sperm mobility and sperm head counts. Under the current test
conditions, the NOAEC for fertility related parameters was 350 ppm (1253
mg/m3) for male and female rats.
While there is no full reproduction study with MAA, Methyl
methacrylate has recently been tested in an OECD TG 416 oral
two-generation reproduction toxicity study in rats, in which both,
parental and F1 animals were dosed with 0; 50; 150 and 400 mg/kg body
weight/day (BASF, 2009a)
In mid- and high-dose parental animals (150 and 400 mg/kg bw/d)
temporary salivation, presumably due to a bad taste of the test
substance and associated dose-related intermittent reductions of food
consumption were noted. Less significant changes were noted for the F1
generation animals where the effects were limited to the high-dose group
and not associated with effects on histopathology or reproductive
The NOAEL for fertility and reproductive performance for the P and
F1 parental rats was determined to be 400 mg/kg bw/day, the highest dose
tested. The NOAEL for developmental toxicity, in the F1 and F2 progeny,
of the test substance was determined to be 400 mg/kg bw/day, the highest
dose tested. There were no signs of systemic toxicity other than reduced
body weight gain associated with reduced food consumption, presumably
due to bad palatability (NOEL 50 mg/kg bw/day for the P and F1 parental
rats and LOEL of 150 mg/kg bw/day in the P parental females).
No reliable data available for any members of the category.
Saillenfait et al. (1999): Developmental study in rats; No effects on development up to 300 ppm (1232 mg/m³), equivalent to a body burden of 409 mg/kg/dBASF (2009b) Developmental study in rats; read-across from MMA; no effects on development up to 450 mg MMA/kg/d, equivalent to 387 mg/kg/d MAA
Regarding developmental toxicity, there is an OECD 414 study on
MAA and rabbit data can be obtained by read-across from MMA. No further
testing is proposed.
The OECD SIAR concluded that: “Methacrylic acid (MAA), the common
metabolite for all the esters, also was tested in groups of 19-25
pregnant female rats (whole-body inhalation exposure for 6 hr/day,
during days 6 to 20 of gestation), at 0, 50, 100, 200, and 300 ppm (0,
179, 358, 716 and 1076 mg/m3) and produced no embryo- or foetal
lethality, nor foetal malformations after exposure with MAA at any
concentration, despite overt maternal toxicity (decreased body weight
and feed consumption) at 300 ppm (1076 mg/m3). The NOAEL for
developmental toxicity was considered 300 ppm (1076 mg/m3) MAA
(Saillenfait et al., 1999).”
For the second species there are no data for MAA, hence data are
obtained by read-across from MMA. Since the ESR and the OECD review
another study with MMA has been performed, an oral OECD 414 study in
rabbits at 50, 150 , and 450 mg/kg/d. The no observed adverse effect
level (NOAEL) for prenatal developmental toxicity is 450 mg/kg bw/d. No
adverse foetal findings of toxicological relevance were evident at any
dose, even in the presence of maternal toxicity (BASF, 2009b).
In the absence of
specific reproductive toxicity and by analogy to MMA, MAA is not
regarded as toxic to reproduction.
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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