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EC number: 213-086-1 | CAS number: 923-02-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No study available.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 69 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- The key studies are of sufficient validity, Klimisch 1 or 2.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There is no study available for N-methylol methacrylamide itself.
For the structurally closely related methacrylamide, there was no evidence for impairment of fertility when administered via drinking water in a one-generation study on toxicity to reproduction in mice.
There is no evidence for teratogenicity or other effects on toxicity to reproduction in methacrylamide studies. The lowest NOAEL described for that endpoint is 49 mg/kg/d.
The observation of a temporarily slightly diminished grip strength in juvenile mice described by the study authors in the one-generation toxicity to reproduction study on methacrylamide (key study) is considered as irrelevant (for more details see developmental toxicity).
In an OECD TG 421 reproduction / developmental toxicity screening test in rats, no effects were observed below the range of general, maternal toxicity.
Short description of key information:
There is no study available for N-methyl methacrylamide itself.
For the structurally closely related methacrylamide, there was no evidence for impairment of fertility when administered via drinking water in a one-generation study on toxicity to reproduction in mice. In a OECD TG 421 study in rats, no effects were observed below the range of general maternal toxicity.
Justification for selection of Effect on fertility via oral route:
For the structurally closely related methacrylamide, normal fertility was observed within a one-generation study in mice exposed to doses up to 240 ppm (69 - 71 mg/kg/d).
Effects on developmental toxicity
Description of key information
There is no study available for N-methylol methacrylamide itself.
For the structurally closely related methacrylamide, there was no evidence for adverse effects on developmental toxicity when administered via drinking water in a one-generation study on toxicity to reproduction in mice.In a prenatal developmental toxicity study equivalent to OECD TG 414 in mice, the NOAEL for maternal and developmental toxicity was 60 mg/kg/d. For teratogenicity, the NOAEL was 180 mg/kg, the highest administered dose.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 69 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- The key studies are of sufficient validity, Klimisch 1 or 2.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There is no study available for N-methylol methacrylamide itself.
For the structurally closely related methacrylamide, there was no evidence for adverse effects on developmental toxicity when administered via drinking water in a one-generation study on toxicity to reproduction in mice.In a prenatal developmental toxicity study equivalent to OECD TG 414 in mice, the NOAEL for maternal and developmental toxicity was 60 mg/kg/d. For teratogenicity, the NOAEL was 180 mg/kg, the highest administered dose.
The observation of a temporarily slightly diminished grip strength in juvenile mice described by the study authors in the one-generation toxicity to reproduction study on methacrylamide (key study) is considered as irrelevant for the NOAEL determination on the following reasons: Published data reveal a strong correlation between body weight of the test animals and grip strength (literature: Maurissen JP et al: Neurotoxicol Teratol. 2003 Sept-Oct; 25 (5): 543-53).
The data presented in the one-generation toxicity to reproduction study on methacrylamide show clearly diminished body weights of the dose group animals compared to the control groups at day 21 post partem. The average difference is 1.04 g for males and 0.89 g for females which is about 8.5 % (males) and 8 % (females) of the body weight at this age. Such a depression in body weights in the dose groups as a result of decreased palatability, especially in the beginning of administration, is a common effect which is reported in numerous oral toxicity studies.
Moreover, the difference in body weights is expected to be even aggravated as the age of the control animals during the grip strength measurements (average 29.2 days for males and females) was significantly higher than that of dose group animals (average 27.2 days [males and females] for the lowest dose group, 26.8 [females] and 27.3 [males] for the medium dose group and 28.2 [males and females] for the highest dose group).
It is expected that an age increase of 1 - 2 days will lead to significant higher body weights in mice during this phase of strong juvenile growth.
In this context it is important to notice that at the day of grip strength measurements, body weights of the animals are not reported. Therefore, the possibility for proof of a direct correlation between body weight and grip strength is lacking in this study.
In conclusion, taking into account the bias caused by diminished body weights of the dose group animals versus control animals the effect of temporarily slightly diminished grip strength described by the study author as slight indication of neurotoxicity in immature animals cannot be confirmed. The invalidity of that finding is aggravated by the lack of body weight data on the test days. The minor manifestation and reversibility of the described effect is taken into consideration as well.
Justification for selection of Effect on developmental toxicity: via oral route:
For the structurally closely related methacrylamide, no adverse effects on developmental toxicity were observed within a one-generation study in mice exposed to doses up to 240 ppm (69 - 71 mg/kg/d).
Justification for classification or non-classification
In the view of the overall database, N-methylol methacrylamide has not to be classified for toxicity to reproduction.
Additional information
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