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EC number: 240-714-1 | CAS number: 16669-27-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Developmental Toxicities of Methacrylic Acid, Ethyl Methacrylate, n-Butyl Methacrylate, and Allyl Methacrylate in Rats following Inhalation Exposure.
- Author:
- Saillenfait AM, Bonnet P, Gallissot F, Peltier A, Fabriès
- Year:
- 1 999
- Bibliographic source:
- Toxicological Sciences 50: 136-145
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Methacrylic acid
- EC Number:
- 201-204-4
- EC Name:
- Methacrylic acid
- Cas Number:
- 79-41-4
- Molecular formula:
- C4H6O2
- IUPAC Name:
- 2-methylprop-2-enoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA Credo Breeding Laboratories, France
- Age at study initiation: not specified
- Weight at study initiation: 180-200 grams
- Housing: mated females were housed in clear polycarbonate cages with stainless steel wire lids and hardwood shavings for bedding
- Diet: food pellets, ad libitum, except during exposure
- Water: tap water, ad libitum, except during exposure
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2 °C
- Humidity (%): 50± 5%
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Exposures were whole body and conducted in a 200 L glass/stainless-steel inhalation chamber with dynamic and adjustable laminar air flow (6-20 m3/h). Chamber temperature was 23°C, and the relative humidity was 50%. Air was passed through a heated bubbler containing test material. The vaporized material was then introduced into the exposure chambers.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations were monitored continuously with a GC, and were determined once during each 6 hr exposure by collecting the material and analyzing against a standard using GC.
- Details on mating procedure:
- Mating: 2-3 females were caged with one male rat
The onset of gestation was based upon the presence of sperm in the vaginal smear and this was designated gestation day 0. After confirmation of mating, females werereturned to an individual cage. - Duration of treatment / exposure:
- 6 hours per day
- Frequency of treatment:
- day 6 to 20 of gestation
- Duration of test:
- mated females were exposed 6 hr/day on days 6 through 20 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 ppm
- Remarks:
- 55.3 ± 8.1 ppm analytical concentration
- Dose / conc.:
- 100 ppm
- Remarks:
- 101.5 ± 16.9 ppm analytical concentration
- Dose / conc.:
- 200 ppm
- Remarks:
- 207.3 ± 24.7 ppm analytical concentration
- Dose / conc.:
- 300 ppm
- Remarks:
- 316.0 ± 36.7 ppm analytical concentration
- No. of animals per sex per dose:
- 19-25 pregnant females per dose
- Control animals:
- other: yes, concurrently to filtered room air
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: / No data
BODY WEIGHT: Yes
FOOD CONSUMPTION Yes
for the intervals GDs 6-13 and 13-21
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: uterus
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- Live fetuses were weighed, sexed, and examined for external anomalies. 50% of the live fetuses were preserved in Bouin's solutionand examined for internal soft-tissue changes. The remaining fetuses were fixed in ethanol (70%), eviscerated and then processed for skeletal staining with alizarin red S.
- Statistics:
- The number of CL, implantation sites,and live fetuses, maternal food consumption and various body weights were analyzed by ANOVA, followed by Dunnett'st-test. the percentage of non-live implant, resorptions,and males and the proportion of fetuses with alterations ineach litter were evaluated by Kruskal-Walles test followed by Dixon-Massey test. Rates of pregnancy and percentage of litters with any malformations or external, visceral, or skeletal variations were analyzedusing Fisher's test. Where appropriate, least squares analysis was performed. The level of significance was p < 0.05.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Exposure to 300 ppm led to significant decreases in maternal weight gain. Absolute weight gain was significantly reduced at 300 ppm.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Exposure to 300 ppm led to significant decreases in maternal food consumption.
Maternal developmental toxicity
- Pre- and post-implantation loss:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 200 ppm
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- There were no significant changes in number of implantations and live fetuses, in the incidence of non-live implants and sorptions, or in fetal weights across groups. One fetus of 200 ppm and two of the 300 ppm group showed different types of malformations. There was no consistent pattern of changes to suggest any treatment-related effects. The difference of fetuses with external, visceral, and skeletal variations did not differ between the control and the treated groups. No significant increase in embryo/fetal lethality or fetal malformations was observed after exposure. While maternal toxicity was observed, methacrylic acid caused no evidence of developmental toxicity up to 300 ppm.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- >= 300 ppm
- Sex:
- male/female
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1: Reproductive parameters in Sprague-Dawley Rats Inhaling Methacrylic acid on Days 6 to 20 of Gestation and Euthanized on Day 21
Concentration ppm/6h/day |
% of females pregnant at euthanization |
No. of litters |
No. of corpora lutea per dam |
No. of implantation sides per litter |
% of nonlive implants per litter(a) |
% of resorption sites per litter |
No. of live fetuses per litter |
% of males per litter |
0 |
92 |
23 |
17.05 ± 1.7(b) |
14.91 ± 5.06
|
8.96 ± 20.73
|
8.96 ± 20.73
|
14.73 ± 3.92
|
56.37 ± 17.76
|
50 |
88 |
22 |
16.10 ± 1.76 |
15.36 ± 1.97
|
3.22 ± 3.34
|
3.22 ± 3.34
|
14.86 ± 1.93
|
49.70 ± 14.90
|
100 |
84.6 |
22 |
16.23 ± 1.74 |
15.00 ± 2.93
|
6.76 ± 8.14
|
6.76 ± 8.14
|
14.05 ± 3.17
|
58.70 ± 13.10 |
200 |
88 |
22 |
16.32 ± 2.12 |
14.36 ± 3.74 |
5.67 ± 12.77
|
5.67 ± 12.77
|
13.77 ± 3.99
|
53.91 ± 17.15 |
300 |
88.5 |
23 |
16.00 ± 2.73 |
14.43 ± 4.63 |
10.61 ± 21.45
|
10.61 ± 21.45
|
14.05 ± 3.76
|
50.40 ± 16.30
|
Concentration ppm/6h/day |
Average fetal body weight (g) all |
Average fetal body weight (g) males |
Average fetal body weight (g) females |
0 |
5.71± 0.56
|
5.86± 0.57
|
5.42± 0.37 |
50 |
5.66± 0.27
|
5.82± 0.32
|
5.49± 0.27 |
100 |
5.79± 0.30
|
5.92± 0.32
|
5.62± 0.32 |
200 |
5.76± 0.47
|
5.92± 0.47
|
5.54± 0.45 |
300 |
5.67± 0.49
|
5.71± 0.34
|
5.54± 0.52 |
(a) resorptions plus dead fetuses
(b) values are expressed as means ± SD
Applicant's summary and conclusion
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.
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