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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Jun 1987 to 10 Dec 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Jun 1987 to 10 Dec 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Objective of study:
- toxicokinetics
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD TG 427
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-Hydroxyethyl acrylate
- Source: Sigma Chemical Company, St. Louis, MO (radiolabelled), Epoxy Products Department of The Dow Chemical Company, Freeport, TX (non-radiolabelled)
- Analytical purity: molar purity of 98.3 %, as determined by gas chromatography and infrared analysis (Hermann, 1991)
- Lot/batch No.: 059F9245 (radiolabelled), TB 881212 (non-radiolabelled)
- Radiochemical purity (if radiolabelling): 100 % as determined by high preformance liquid chromatography (HPLC, Analytical Data Sheet 89-397) (upon receipt). The radiochemical purity was evaluated repeatedly throughout the study (Analytical Data Sheets 90-9, 91-5, 90-124, 91-29, 91-33) and ranged from 100 % to 87 %.
- Specific activity (if radiolabelling): 6.3 mCi/mmol (MW 116)
- Locations of the label (if radiolabelling): uniformly labelled 14C-HEA - Radiolabelling:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (Kingston, NY; Raleigh, NC)
- Age at study initiation: young adult animals
- Weight at study initiation: approx. 200 g
- Fasting period before study: feed withdrawal approximately 8 hr prior to administration of the 14C-HEA and food was returned about 4 hr post-dosing for all routes of exposure.
- Individual metabolism cages: no data
- Diet (ad libitum): certified rodent chow (Purina Mills Inc., Purina #5002)
- Water (ad libitum): municipal tap water
- Acclimation period: at least one week plus acclimation to glass Roth-type metabolism cages for at least 2 days prior to the administration
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h / 12 h - Route of administration:
- dermal
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: interscapularly and as far anteriorly on the back as possible, 4 cm2
- Type of wrap if used: Immediately after dosing, the dosed area was covered with a piece of teflon@ film (4 an X 4 an) which was secured to the Stomahesive patch/well with surgical adhesive. The dosed area was then wrapped with veterinary bandaging tape.
- Time intervals for shavings or clipplings: before exposure
- Duration and frequency of treatment / exposure:
- 48 hr exposure
- Dose / conc.:
- 12.5 mg/kg bw/day
- Remarks:
- corresponding to 15-20 µCi of radioactivity
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Details on study design:
- After administration or termination of exposure to 14C-HEA, rats from all groups were housed in glass Roth-type metabolism cages. All urine, cage rinse, and feces were collected at specified intervals for up to 48 hr post-dosing or post-exposure and analyzed for radioactivity. In addition, expired organics and 14CO2 were trapped for the 48 hr post-dosing or post-exposure period. Selected samples of urine were analyzed by high performance liquid chromatography (HPLC) to determine 14C metabolic profiles.
The rats were sacrificed 48 hr after administration or exposure to 14C-HEA, and the radioactivity remaining in samples of blood, skin, and the carcass was quantified. For the dermal route of administration, the radioactivity associated with the skin at the dosed site was also determined. in order to determine blood concentration-time profiles, separate groups of animals (different from the groups used to determine the disposition of HEA) were utilized so that expired 14CO2 would not be lost while blood was collected from the animals in the Roth cages.
Radioactivity was quantified with a Beckman LS 3801 or Beckman LS 9000 liquid scintillation Counter (Beckman Instrument Inc., Fullerton, CA). - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, blood, plasma, serum, cage washes, bile, 14CO2
- Time and frequency of sampling:
urine (0-12, 12-24 and 24-48 hr post-dosing), faeces (at 24 hr intervals), 14CO2 (0.25, 0.5, 1, 2, 4, 8, and 12 hr post-exposure) (trapped in a mixture of CO2 trapping solution (monoethanolamine: methoxy-2-propanol, 3:7, v/v) and combustion scintillant (Spectrafluor@:methoxy-2-propanol:toluene 12:22:66, v/v)
Blood samples (100 µL) for the 14C plasma and red blood cell time-couse determinations were collected at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 30 and 48 hr after the administration of 14C-HEA by the dermal route. - Statistics:
- The half-lives for the CO2 excretion and the plasma radioactivity were determined from the slope of the line obtained by regression analysis of the excretion time-course obtained from each treatment group. Statistical analysis of the data was limited to the calculation of means and standard deviations where appropriate. Pharmacokinetic analysis (calculation of half-lives, AUC's etc.) were carried out using standard methodologies.
- Details on distribution in tissues:
- For the dermal route of administration, about 33 % of the applied dose recovered was associated with the skin or materials used for restricting access to the dermal dose site. Of this 33 %, 11 % of the applied radioactivity was associated with the dosed skin and the remaining 22 % was recovered in the components of the bandage (Stomahesive patch/well, which defined the dosed site, Teflon@ cover and VetRap@). Nine percent of the dose was found in the tissues and carcass.
- Details on excretion:
- For the dermal route of administration, 27 % of the radioactivity was recovered in the urine and a similar amount of 27 % was recovered as 14CO2. Less than 1 % of the dose was found as volatile organics in the expired air and in the final cage wash and only 0.6 % of the dose was recovered in the faeces.
Following dermal application, nonquantifiable levels of 14CO2 were observed for up to one half hour post application. In addition, there was a lag in peak 14CO2 excretion as compared to the oral and ip routes of administration. This peak occurred at the 12-24 hr collection interval. By 12 hr post-dosing, only 13 % of the dose had been eliminated as 14CO2 in the expired air. The exhalation of 14CO2 derived from 14C-HEA appeared to follow first-order kinetics as a biphasic process, except following dermal administration.
For the dermal route of administration, 38 % of the total radioactivity excreted via the urine was excreted during the 0-12 hr interval and about the same percentage was excreted in the 12-24 hr collection interval. - Metabolites identified:
- yes
- Details on metabolites:
- HPLC analyses were performed on pooled urine specimens from all treatment groups. Recovery from the HPLC System ranged from 90% to 114%. For all treatment groups, the radiochromatograms of the urinary metabolites contained four major peaks or peak groups of radioactivity. One metabolite could be identified as N-acetyl-S-(carboxylethyl)cysteine by GC/EI/MS. No attempts were made to identify the other three major 14C peaks, however, none of the three peaks were found to correspond to the retention times of HEA or acrylic acid.
The average 14C-HEA doses (mg/kg bw) administered to the dermal treatment group ranged from 84 % to 107 % of target.
No signs of toxicity were observed following dermal administration. In addition, at 48 hr post-dermal application there was an absence of skin irritation.
Since an average of only 66 % of the applied dermal dose was absorbed within 48 hr post-dosing, the dermal absorption of 14C-HEA was a relatively slow process.
The data show, that once systemically available, HEA is rapidly metabolized and eliminated from the body.
Half-lives:
Following the 12.5 mg/kg dermal dose, the half-life for the terminal phase of elimination via 14CO2 was determined to be approximately 17 hr. The half-life for the initial phase of elimination was 4.9.
For the dermal route of administration the half-life of elimination in the urine was approximately 14 hr.
The blood concentration-time profile following dermal administration showed a slow rise in 14C blood concentrations from 15 min post-dosing to peak at 12 hr postdosing, suggesting a slow rate of dermal absorption. However, following dermal absorption the plasma radioactivity concentration-time profile was monophasic suggesting a first order process of elimination. The terminal half-life for the disappearance of plasma 14C activity following dermal dosing was 45 hr. However, this may actually represent the half-life for absorption.
Distribution of radioactivity 48 hr after exposure:
Tissues |
Dermal * |
12.5 mg/kg bw |
|
Urine |
27.38 ± 3.06 |
Faeces |
0.59 ± 0.41 |
Tissues & carcass |
9.19 ± 0.93 |
14CO2 |
26.53 ± 2.73 |
Volatile organics |
0.36 ± 0.45 |
Cage wash |
0.70 ± 0.28 |
Dose site |
32.80 ± 6.16 |
Total |
97.54 ± 1.06 |
* Percent of dose
Values represent Mean ± SD for 4 animals.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 427 (Skin Absorption: In Vivo Method)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD TG 417
- GLP compliance:
- yes
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:
- - Name of test material (as cited in study report): 2-Hydroxyethyl acrylate
- Source: Sigma Chemical Company, St. Louis, MO (radiolabelled), Epoxy Products Department of The Dow Chemical Company, Freeport, TX (non-radiolabelled)
- Analytical purity: molar purity of 98.3 %, as determined by gas chromatography and infrared analysis (Hermann, 1991)
- Lot/batch No.: 059F9245 (radiolabelled), TB 881212 (non-radiolabelled)
- Radiochemical purity (if radiolabelling): 100 % as determined by high preformance liquid chromatography (HPLC, Analytical Data Sheet 89-397) (upon receipt). The radiochemical purity was evaluated repeatedly throughout the study (Analytical Data Sheets 90-9, 91-5, 90-124, 91-29, 91-33) and ranged from 100 % to 87 %.
- Specific activity (if radiolabelling): 6.3 mCi/mmol (MW 116)
- Locations of the label (if radiolabelling): uniformly labelled 14C-HEA - Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (Kingston, NY; Raleigh, NC)
- Age at study initiation: young adult animals
- Weight at study initiation: approx. 200 g
- Fasting period before study: feed withdrawal approximately 8 hr prior to administration of the 14C-HEA and food was returned about 4 hr post-dosing for all routes of exposure.
- Individual metabolism cages: no data
- Diet (ad libitum): certified rodent chow (Purina Mills Inc., Purina #5002)
- Water (ad libitum): municipal tap water
- Acclimation period: at least one week plus acclimation to glass Roth-type metabolism cages for at least 2 days prior to the administration
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 48 hr exposure
- Doses:
- 12.5 mg/kg bw (corresponding to 15-20 µCi of radioactivity)
- No. of animals per group:
- 4
- Control animals:
- no
- Details on study design:
- TEST SITE
- Area of exposure: interscapularly and as far anteriorly on the back as possible, 4 cm2
- Type of wrap if used: Immediately after dosing, the dosed area was covered with a piece of teflon@ film (4 cm X 4 cm) which was secured to the Stomahesive patch/well with surgical adhesive. The dosed area was then wrapped with veterinary bandaging tape.
- Time intervals for shavings or clipplings: before exposure
Results and discussion
- Signs and symptoms of toxicity:
- no effects
- Dermal irritation:
- no effects
- Absorption in different matrices:
- - Skin test site: 32.80 ± 6.16 %
- Carcass: 9.19 ± 0.93 %
- Urine: 27.38 ± 3.06 %
- Cage wash: 0.70 ± 0.28 %
- Faeces: 0.59 ± 0.41 %
- Expired air: 26.53 ± 2.73 % (CO2) + 0.36 ± 0.45 % (volatile organics) - Total recovery:
- - Total recovery: 97.54 ± 1.06 %
Percutaneous absorption
- Key result
- Dose:
- 12.5 mg/kg bw
- Parameter:
- percentage
- Absorption:
- ca. 66 %
- Remarks on result:
- other: 48 hr
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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