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EC number: 252-471-9 | CAS number: 35265-04-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
- Principles of method if other than guideline:
- N-Methylethanolamine was vaporized and administered to approximately 15 pregnant rats in one to three concentrations for 7 hr/day on gestation days 7 to 15, and dams were sacrificed on day 20. Fetuses were individually weighed, and two-thirds of them were fixed in Bouin's solution and examined for soft-tissue anomalies. The other one-third were fixed in alcohol, stained with Alizarin Red and examined for skeletal defects.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-methylaminoethanol
- EC Number:
- 203-710-0
- EC Name:
- 2-methylaminoethanol
- Cas Number:
- 109-83-1
- IUPAC Name:
- 2-(methylamino)ethanol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-methylaminoethanol
- Analytical purity: no data
- Lot/batch No.: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study:
- Housing: alone in 38 x 33 x 17-cm polycarbonate cages with filter tops
- Diet: Purina Lab Chow ad libitum
- Water: tap water ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 +/- 2
- Humidity (%): 40 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- clean air
- Details on exposure:
- Pregnant females were transported from the animal quarters to the inhalation chambers in their home cages with filter tops (Hazleton Systems, Aberdeen, MD). They were placed individually in 13 x 25 x 189-cm stainless steel wire mesh cages within exposure chambers.
Air flow through the chambers provided approximately four air changes per minute.
Exposures were conducted sequentially in one or two chambers, with a third chamber for sham exposure of control subjects.
Control animals were placed in similar chambers for the same hours as the exposed animals; a pooled group of controls (N = 34) served as the comparison group for the first three chemicals examined. Another group of 15 controls served as the comparison group for the last two chemicals examined, as these groups were exposed at a later time (approximately 6 months later) than the first three. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentrations within the exposure chambers as measured by the infrared analyzer were relatively close to those obtained from gas chromatography.
- Details on mating procedure:
- Males weighing over 300 g were placed individually into a cage with three females weighing 200 to 300 g. Vaginal smears were taken each morning, and the presence of sperm marked day zero of gestation.
- Duration of treatment / exposure:
- Exposures conducted 7 hr/day, and the animals were left in the chamber for at least one additional hour blow-off time after vapor generation terminated. They were then returned in their individual housing cages to the animal quarters, where water bottles were replaced.
- Frequency of treatment:
- Exposures were conducted on gestation days 7-15.
- Duration of test:
- On day 20 of gestation, dams were sacrificed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150.0 +/- 15.2 ppm (460 +/- 46 mg/m3)
Basis:
analytical conc.
- No. of animals per sex per dose:
- approximately 15 pregnant rats
- Control animals:
- other: three solvents were compared with a pooled group (N = 34) of sham-exposed controls, and the remaining two were compared with a group of 15 controls.
Examinations
- Maternal examinations:
- Feed and water intake and maternal weight were recorded weekly (i.e., on days 7, 14, and 21); any other signs of maternal toxicity were noted daily.
On day 20 of gestation, the females were individually weighed and euthanized by chloroform asphyxiation. - Ovaries and uterine content:
- The entire uterus was removed and numbers of resorption sites (classified as early, middle or late) and live fetuses wvere determined.
- Fetal examinations:
- Fetuses were serially removed, blotted of excess fluids, weighed, examined for external malformations and external sex determined.
One third of the fetuses were randomly selected and placed in 95% ethanol, and the remainingfetuses were placed in Bouin's solution. After being in
the Bouin's solution for at least 1 week, these fetuseswere examined for visceral abnormalities using Wilson's razor blade sectioning technique. The viscera wereexamined with the aid of a dissecting microscope. A representative sample of sections with malformations was identified by dam number and saved in 70% alcohol.
Fetuses were examined for skeletal defects by using a modified Staples technique. They were fixed in 95% alcohol, eviscerated and macerated in 2% KOH/Alizarin Red S solution. The fetuses were further macerated and cleared in the appropriate solutions of 2% KOH/glycerin (60:40, 40:60, 20:80) and stored in 100% glycerin. A crystal of thymol was added to each storage vial to retard fungal growth. Storage vials were individually identified by dam number. - Statistics:
- Numbers of implants and proportions of resorptions were independently analyzed by using a Kruskal-Wallis test corrected for ties, with subsequent multiple comparisons to determine where the differences occurred. Analysis of pup weights involved a mixed model analysis of covariance (with the number of live pups in the litter as the covariate) using maximum likelihood estimation. The model was mixed, since there was both within-litter and between-litter variation. Subsequently, pairwise comparisons between the pooled control group and each treatment group were performed. Incidence oftotal defects and of total variants were compared using a Kruskal-Wallis test with multiple comparisons with the litter as the experimental unit and the level of significance at p< 0.05.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Effects upon pregnancy outcome:
Number pregnant/mated - 15/16 (Control); 18/24 (Treated)
Implants/dam - 13.1 (Control); 11.9 (Treated)
Litters with resorptions - 10 (67%; Control); 10 (56%; Treated)
Live fetuses/litter - 11.6 (Control); 11.8 (Treated)
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- >= 150 other: ppm (analytical) (460 mg/m3)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- >= 150 other: ppm (analytical) (460 mg/m3)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Live fetal body weights - Female, 3.36 (Control); 3.59 (Treated); Male, 3.33 (Control); 3.69 (Treated)
Number of litters with abnormal litter - 5 (Control); 7 (Treated)
Visceral observations (litters/fetuses):
Number litters/fetuses examined - 15/116 (Control); 18/143 (Treated)
Malformations - Brain (hydrocephalus, mild), 3/6 (Control); 3/5 (Treated).
Variations (62 controls; 74 treated) - Testicular (undescended testes) - 0 (Control); 1/1 (Treated); Testicular (position variation) - 10/22 (Control); 9/13 (Treated) - Urinary tract (dilated renal pelvis) - 3/ 4 (Control); 5/5 (Treated); Urinary tract (dilated ureter) - 3/6 (Control); 6/18 (Treated); Urinary tract (hydronephrosis) - 2/2 (Control); 0 (Treated); Urinary tract (hydroureter) - 3/3 (Control); 5/6 (Treated); Urinary tract (ectopic kidney) - 1/1 (Control); 0 (Treated).
% Normal (mean ±standard deviation) - 89 ±26% (Control); 92 ±15% (treated)
% Abnormal (mean ±standard deviation) - 11 ±26% (Control); 8 ±15% (treated)
Skeletal observations (litters/fetuses):
Number litters/fetuses examined - 14/58 (Control); 18/69 (Treated)
Malformations - 0 (Control); 0 (Treated)
Variations - Ribs (rudimentary 14th) - 1/1 (Control); 1/2 (Treated); Ribs (rudimentary lumbar) - 0 (Control); 1/1 (Treated); Skull (incomplete ossification of supraoccipital) - 0 (Control); 1/1 (Treated); Skull (incomplete ossification of interparietal) - 1/1 (Control); 1/2 (Treated); Skull (incomplete ossification of parietal) - 1/1 (Control); 0 (Treated); Sternebrae (decreased number) - 1/1 (Control); 1/1 (Treated); Sternebrae (split) - 0 (Control); 1/1 (Treated); Sternebrae (misaligned) - 1/1 (Control); 5/5 (Treated); Centra (misshapen thoracic) - 1/1 (Control); 5/5 (Treated); Pelvic Girdle (pubis missing) - 0 (Control); 2/2 (Treated); Pelvic Girdle (ischium missing or reduced in size) - 0 (Control); 1/1 (Treated).
% Normal (mean ±standard deviation) - 100 ±0% (Control); 100 ±0% (treated)
% Abnormal (mean ±standard deviation) - 0% (Control); 0% (treated)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- N-Methylethanolamine showed neither maternal nor fetal toxicity effects.
- Executive summary:
N-Methylethanolamine was vaporized and administered at 150 ppm to approximately 15 pregnant rats for 7 hr/day on gestation days 7 to 15, and dams were sacrificed on day 20 of gestation. Fetuses were individually weighed, and two-thirds of them were fixed in Bouin's solution and examined for soft-tissue anomalies. The other one-third were fixed in alcohol, stained with Alizarin Red and examined for skeletal defects. As overall result for the substance N-Methylethanolamine it can be stated that neither maternal nor fetal toxicity effects can be concluded in this study.
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