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EC number: 201-204-4
CAS number: 79-41-4
There is a 90 d inhalation study for MAA
(BASF 2009). There are no studies by other routes and chronic data are
absent. The endpoint is satisfied by read-across from MMA.
There are no relevant oral repeated dose
studies. For assessment purposes the inhalation data are used with
appropriate route-to-route extrapolation factors.
There are no relevant dermal repeated
dose studies for systemic effects. For assessment purposes the
inhalation data are used with appropriate route-to-route extrapolation
The available 3 -week study
(Rohm and Haas 1986) is used as supporting information for
classification and labelling purposes.
In an OECD 413 guideline study
(subchronic inhalation toxicity: 90-day) 10 male and female Sprague
Dawley rats per test group were whole body exposed to a vapour of the
test substance on 6 hours per working day for 90 days (65 exposures)
(BASF, 2008). The target concentrations were 20, 40, 100 and 350 ppm
(corresponding to 70, 141, 352 and 1232 mg/m3). A concurrent control
group was exposed to conditioned air.
At 350 ppm, the local irritating effect
(hypertrophy/hyperplasia of the respiratory epithelium in the nasal
cavity) was minimal in only 2/10 female animals and represents a LOAEC
for local effects. 100 ppm (352 mg/m³) was the NOAEC for local effects
in male and female animals.
There were no adverse systemic findings
in any organs including sexual organs, or any changes of sperm mobility
and sperm head counts, at the highest dose investigated 350 ppm (1232
mg/m³). Therefore, the no-observed adverse effect level (NOAEC) for
systemic organ effects in this study is 350 ppm in male and female rats.
Body weight effects
Methacrylic acid caused reduced food
consumption and transiently food efficiency in the high concentration
male animals resulting in decreased terminal body weight and body weight
gain in these animals. In the absence of any true systemic organ related
effects at this dose level these are not considered to be adverse
findings. The overall no-observed effect level (NOAEC) for local effects
and systemic effects including body weight in this study is 100 ppm for
the male and female rats.
In regard to chronic toxicity by
inhalation two aspects are not considered to be progressing over time –
body weight effects caused by reduced food consumption and nasal lesions
caused by local irritation. For true systemic toxicity, data are used by
read-across from MMA: After a 14-week inhalation, mice had cellular
necrosis in liver and renal cortices > ca. 8.2 mg/L (2,000 ppm) and rats
showed splenic follicular atrophy and bone marrow atrophy at ca. 20.8
mg/L (5,000 ppm; Battelle 1980). Malacia and gliosis of the brain in the
14 week range finder to the NTP study (Battelle, 1980) is considered
being the relevant systemic effect, which was seen in 5/9 female rats
exposed at 2000 ppm and 1/8 females at 1000 ppm. Therefore, the absence
of this effect at 500 ppm (2028 mg/m³) in the corresponding 2-year study
(NTP) is considered representing the NOAEC for chronic systemic effects
As the no-observed adverse effect level
(NOAEC) in the subchronic study on MAA (100 ppm) is below the NOAEC for
other systemic effects in the chronic study with MMA it is protective
for systemic toxicity and therefore can be used as the basis for the
In a subchronic 90 d inhalation study with MAA there was no indication
of severe or irreversible organ effects other than irritation in tissues
of the upper respiratory tract at 350 ppm (1232 mg/m³).
Therefore, no classification is proposed for chronic specific target
organ toxicity (STOT repeated exposure). The observed irritation is
covered by classification as a respiratory irritant (STOT single
exposure), category 3.
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