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EC number: 203-804-1 | CAS number: 110-80-5
- 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

Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratogenicity of 2-Ethoxyethanol by Dermal Application
- Author:
- Hardin, B.D. et al.
- Year:
- 1 982
- Bibliographic source:
- Drug. Chem. Toxicol. 5, 277-294
Materials and methods
- Principles of method if other than guideline:
- Method: other: Subacute dermal toxicity
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-ethoxyethanol
- EC Number:
- 203-804-1
- EC Name:
- 2-ethoxyethanol
- Cas Number:
- 110-80-5
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 2-ethoxyethan-1-ol
- Details on test material:
- Name of the test substance as stated in the publication: 2-Ethoxyethanol
purchased from: Fisher Scientific (Catalog No. E180, Lot No 701071;
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals were purchased from: Charles River Breeding Laboratories, Wilmington, Massachusetts;
Weight of female virgins 200-225 g
Administration / exposure
- Type of coverage:
- not specified
- Details on exposure:
- Route of administration: dermal
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- 4 times per day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.25, 0.50 mL
Basis:
other: 4 times daily per animal
- No. of animals per sex per dose:
- pregnants of control: 22
pregnants at dose 0.25 mL: 21
pregnants at dose 0.50 mL: 24 - Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- Recording of body weights on days 1, 7, 16, and 21 of gestation
- Sacrifice and pathology:
- Females were killed by decapitation on day 21;
Recording of organ weight (liver, spleen, kidney, and gravid uterus)
Results and discussion
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 1 other: mL/day
- Based on:
- test mat.
- Basis for effect level:
- other: No signs of maternal toxicity were noted except ataxia in the 0.50 mL (2.0 mL/day) dose group in the last days of treatment; in the 0.25 mL (1 mL/day) dose group malformations in the offspring were observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Results of dose-finding study:
No toxic signs were noted except ataxia on treatment days 9 and 10 in the 2.0 mL/day group and on treatment day 10 in the 1.4 mL/day group. Group mean body weights did not differ significantly from at any time, and no dose-related changes were seen. Similarly, liver and kidney weights were not altered by the 2 -ethoxyethanol treatments.
Results of teratology study:
No signs of maternal toxicity were noted except ataxia in the 0.5 mL dose group in the last days of treatment. Mean maternal body weights of the control and treated groups did not differ on days 1, 2, or 16, but on day 21 each group differed significantly from the others. Significant differences in maternal organ weights were seen only in the higher dose group, in which maternal liver weights were reduced while kidney weights were increased. There were no pregnant females with live fetuses in the 0.50 mL dose group, and only 11 of 21 pregnant females at the lower dosage had live fetuses. In the 0.25 mL dose group, both the number of live implants per litter and the mean body weight of fetuses were significantly reduced. Only two externally visible malformations were noted, both in fetuses from the 0.25 mL treatment group: one fetus had an umbilical hernia, another had no tail. Visceral and skeletal examiniations of live fetuses, revealed significantly increased incidences of several defects in the 2 -ethoxyethanol- treated litters: cardiovascular malformations and various types of deviations from normal skeletal development.
Remark of the author of this IUCLID dossier:
Since in the lowest dose group (1 mL per animal and day) malformations in the offspring were observed, this value corresponds to the LOAEL. With a density of 0.919 g/mL at 25 °C the daily applied amount was 919 mg/animal/day. With respect to the average body weight in that dose group on day 21 of gestation (304 +/- 29 g) the applied concentration was 3023 mg/kg/day.
Applicant's summary and conclusion
- Conclusions:
- 2-ethoxyethanol can be classified as a teratogen in Sprague-Dawley rats, as embryo mortality was 100 % at a dose that caused only very mild signs of maternal toxicity (2 mL per animal and day). As in the lowest dose group (1 mL per animal and day) malformations in the offspring were observed, in the opinion of the author of this IUCLID dossier this value corresponds to the LOAEL.
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