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EC number: 212-454-9 | CAS number: 818-61-1
- 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: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Study was conducted prior to the advent of GLP regulations (1982)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
- Deviations:
- yes
- Remarks:
- lesser haematological and clinical parameters have been investigated and no urinalysis was conducted; only 2 animals/dose/sex tested
- Principles of method if other than guideline:
- Groups of male and female Beagle dogs (2/sex/group) were maintained for 97 days on a diet containing 0.06, 0.2, or 0.4 % HEA in diet (equivalent to doses of 21, 60 and 125 and 22, 63 and 131 mg/kg body weight/day for males and females respectively).
- GLP compliance:
- no
- Remarks:
- (Study was conducted prior to the advent of GLP regulations)
- Limit test:
- no
Test material
- Reference substance name:
- 2-hydroxyethyl acrylate
- EC Number:
- 212-454-9
- EC Name:
- 2-hydroxyethyl acrylate
- Cas Number:
- 818-61-1
- Molecular formula:
- C5H8O3
- IUPAC Name:
- 2-hydroxyethyl acrylate
- Test material form:
- not specified
- Details on test material:
- not specified
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: 97 %
- Source: Texas Division
- Physical state: pale yellow liquid
- Density: ca. 1.07
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6-7 months
- Weight at study initiation: no data
- Housing: 2 dogs/cage
- Diet (ad libitum): Purina Laboratory Chow mixed with 1 % peanut oil
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
no details
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 97 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 21 mg/kg bw/day (nominal)
- Remarks:
- administered in males
- Dose / conc.:
- 60 mg/kg bw/day (nominal)
- Remarks:
- administered in males
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Remarks:
- administered in males
- Dose / conc.:
- 22 mg/kg bw/day (nominal)
- Remarks:
- administered in females
- Dose / conc.:
- 63 mg/kg bw/day (nominal)
- Remarks:
- administered in females
- Dose / conc.:
- 131 mg/kg bw/day (nominal)
- Remarks:
- administered in females
- No. of animals per sex per dose:
- 2
- Control animals:
- yes, plain diet
- Details on study design:
- Post-exposure period: no
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: frequently
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: frequently
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
- Food consumption records were kept weekly throughout the experimental period
HAEMATOLOGY: Yes
- Time schedule for collection of blood: before test start and after 83 days on the diet
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all
- Parameters examined: hematocrit, RBC, hemoglobin, WBC, differential count
CLINICAL CHEMISTRY: Yes
- How many animals: all
- Parameters examined: serum urea nitrogen, alkaline phosphatase, bromsulfophthalein (B.S.P.), serum glutamic oxalacetic transaminase (S.G.O.T.), and serum glutamic pyruvic transaminase (S.G.P.T.) values
URINALYSIS: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
All animals were fasted overnight and weighed before examination at autopsy. Bone marrow smears were taken from the rib of the male and female dogs on the control and 0.4 percent levels of 2-hydroxyethyl acrylate and from the female dogs on the control. The lungs, heart, liver, kidneys, spleen, brain, and testes were removed and weighed.
Portions of each organ, as well as lymph node, esophagus, aorta, pancreas, uterus, ovary, urinary bladder, gall bladder, stomach, skeletal muscle, large intestine, small intestine, spinal cord, pituitary gland, adrenal gland, thyroid, parathyroid, and peripheral nerve were preserved. Hematoxylin-eosin stained sections of the tissues were prepared for microscopic examination. - Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No compound-related effects
- Mortality:
- no mortality observed
- Description (incidence):
- No compound-related effects
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Further details / tables see attachments.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No compound-related effects
Further details / tables see attachments. - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No compound-related effects
Further details / tables see attachments. - Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No compound-related effects
Further details / tables see attachments. - Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No compound-related effects
Further details / tables see attachments. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No compound-related effects
Further details / tables see attachments. - Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- No compound-related effects
Further details / tables see attachments.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: high dose
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 131 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: high dose
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
One female dog on the 0.4 percent level of 2 -hydroxyethyl acrylate was relatively small at the beginning of the experimental period and showed a slight weight loss during this period. This dog was found to have an enlarged spleen. However, upon microscopic examination of the tissues from this animal, no evidence of adverse changes was noted. Thus, the dog's condition was not attributed to the experimental compound.
Thus, there was no evidence of adverse effects as judged by general appearance and behavior, weight gain, food consumption, hematological values, examination of bone marrow, urea nitrogen content and alkaline phosphatase activity in the serum, serum bromsulfophthalein, serum glutamic oxalacetic transaminase and serum glutamic pyruvic transaminase tests, final average body and organ weights, and gross and microscopic examination of tissues.
Details on hematology, clinical chemistry, body weight, organ weights and pathological/microscopic examinations are given in the attachment.
Applicant's summary and conclusion
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