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EC number: 942-732-1 | CAS number: -
- 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)
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the pre-, peri-, and postnatal toxicity of monoethanolamine in rats following repeated oral administration during organogenesis.
- Author:
- Hellwig J, Liberacki AB
- Year:
- 1 997
- Bibliographic source:
- Fundam Appl Toxicol. 1997 Nov;40(1):158-62.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Exposure to the test substance limited to the period of organogenesis (days 6 to 15 of gestation)
- Principles of method if other than guideline:
- 40 pregnant rats/group were exposed to different dose levels of the test item through day 6 to 15 of gestation. On day 20, 25 animals/group were sacrificed and the foetuses extracted for analysis. The remaining 15 animals/group delivered, parents and pups were sacrificed at day 21 post-partum for analysis.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-aminoethanol
- EC Number:
- 205-483-3
- EC Name:
- 2-aminoethanol
- Cas Number:
- 141-43-5
- Molecular formula:
- C2H7NO
- IUPAC Name:
- 2-aminoethanol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Monoethanolamine (MEA) provided by BASF AG (Ludwigshafen, Germany)- Physical state: Liquid- Analytical purity: 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Karl Thomae (Biberach an der Riss, Germany)- Weight at study initiation: 200 - 300 g (female rats)- Housing: Stainless steel wire-bottom cages during breeding and until day 18 of gestation. At day 18, pregnant females were put in nesting cages with cellulose wadding).- Diet: ad libitum- Water: ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature: 22°C +/- 2°C- Humidity: 50% +/- 20%- Photoperiod: 12hrs dark / 12hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE- Amount of vehicle: 10 ml/kg
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused- M/F ratio per cage: 1 male / 2-4 females- Length of cohabitation: one night- Verification of same strain and source of both sexes: yes- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Duration of treatment / exposure:
- Through day 6 to 15 of gestation.
- Frequency of treatment:
- Daily
- Duration of test:
- 25 animals/group are sacrificed at day 20 of gestation15 animals/group are sacrificed at day 21 post-partum
- No. of animals per sex per dose:
- 40 pregnant rats
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: A preliminary study was performed. Highest dose was selected in order to induce maternal toxicity but no death or suffering.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes- Time schedule: dailyDETAILED CLINICAL OBSERVATIONS: Yes- Time schedule: dailyBODY WEIGHT: Yes- Time schedule for examinations: Days 0, 1, 3, 6, 8, 10, 13, 15, 17, and 20 of gestation, and days 4, 7, 14, and 21 post-partumFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes. Starting on Day 0 of gestation: every 2-3 days.WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data- Time schedule for examinations:POST-MORTEM EXAMINATIONS: Yes- Sacrifice on gestation day 20
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: YesExaminations included:- Gravid uterus weight: Yes- Number of corpora lutea: Yes- Number of implantations: Yes- Number of resorptions: Yes
- Fetal examinations:
- - External examinations: Yes: [all per litter]- Soft tissue examinations: Yes: [all per litter]- Skeletal examinations: Yes: [half per litter]- Head examinations: No data
- Statistics:
- - Fisher's exact test used for maternal mortality, pregnancy rate, female fertility and gestation indexes, number of liveborn and stillborn pups, and pup survival.- Dunnett's test and Analysis of variance used for feed consumption, body weight, body weight changes, body weight gain, gravid uterine weight, fetal and placental weights, number of corpora lutea, implants, resorptions, live fetuses and pre-implantation/post-implantation lossess, pup body weights, duration of gestation, number of pups delivered per litter.- Wilcoxon test used for evaluation of the proportion of fetuses with malformations/variations.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: significant reduction of the body weightsDetails on maternal toxic effects:Animals treated at 450 mg/kg bw/day showed significant reduction in food consumption. No significant reduction was observed for the other doses.Animals treated at 450 mg/kg bw/day showed significant reduction in body weight and body weight gain. No significant reduction was observed for the other doses.One animal treated at 40 mg/kg bw/day died. It was not considered as significant.No significant differences were observed regarding pregnancy rate, numbers of corpora lutea, number of implantations, resorptions, and viable fetuses, litter size, mean fetal body weight, or gravid uterine weight at any dose.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 450 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 120 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effectsDetails on embryotoxic / teratogenic effects:No significant differences in the sex ratio and mean fetal weights were observed at any dose.No dose-related increased in the incidence of malformations were observed. Sporadic malformations included microphthalmia, dilated renal pelvis, hydroureter, dilatation of the right or both heart ventricles, dextrocardia, unilobular lung, hyperplasia or hypoplasia of the kidneys, and asymmetrical thoracic vertebral bodies.One fetus from the 450 mg/kg bw/day group showed anasarca as a malformation. This was not considered as significant. No significant effects were observed for pups from litters in any dose group, apart from sporadic reductions of body weights until Day 14 post-partum in treated litters. These effects were not considered as dose-related.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The developmental toxicity of the test item was determined according to a method similar to OECD 414. The NOAEL (developmental) is above 450 mg/kg bw/day, which is the highest concentration evaluated during this study. As the highest dose was selected in order to induce maternal toxicity, the NOAEL (maternal) is 120 mg/kg bw/day.
- Executive summary:
The prenatal developmental toxicity of the test substance was determined according to a method similar to the OECD Guideline for Testing of chemicals 414. The developmental toxicity of the substance dispersed in water was studied in rats following a daily exposure through day 6 to 15 of gestation during the organogenesis. A preliminary study was performed in order to determine a highest dose that would induce some maternal toxicity but not death or severe suffering. The selected doses were 0, 40, 120 and 450 mg/kg bw/day.
25 animals per dose were sacrificed at Day 20 of gestation - one day before the parturition - while 15 animals per dose were allowed to deliver. Remaining parents and pups were sacrificed at Day 21 post-partum at the end of the lactation.
Body weights were recorded on days 0, 1, 3, 6, 8, 10, 13, 15, 17, and 20 of gestation, and days 4, 7, 14, and 21 post-partum. All animals were observed daily for appearance and behaviour. Food consumption was determined every 2-3 days.
Sacrificed animals were all subject to post-morterm examination. Gravid animals were examined from uterus weight, and number of corpora lutea, implantations, and resorptions. Fetuses underwent external examination, along with soft tissue examination. Half were stained with alizarin red-S for skeletal examination.
Animals delivered by the surviving females were examined for liveborn and stillborn, sexed, weighed on Day 1, 4, 7, 14, and 21 post-partum. Litters were examined daily for mortality and clinical symptoms. All animals were examined for external and internal examination.
In accordance with the preliminary testing, the highest dose of 450 mg/kg bw/day induced some maternal toxicity with a significant reduction of the food consumption, which led to a significant reduction in body weight and body weight gain. No other significant effects were reported for any dose. It was concluded that the NOAEL (developmental toxicity) was 450 mg/kg bw/day, as the highest dose tested had no significant effects.
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