Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-542-5 | CAS number: 1330-61-6
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Relative Developmental Toxicities of Acrylates in Rats following Inhalation Exposure.
- Author:
- Saillenfait AM et al.
- Year:
- 1 999
- Bibliographic source:
- Toxicol. Sciences 48: 240-254
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 20-29 bred female rats (17-25 pregnant) were exposed to the compound 6h/day on days 6 through 20 of gestation by inhalation. Control animals were exposed concurrently to filtered room air. The test concentrations of ethylhexyl acrylate were 50, 75, and 100 ppm (corresponding to approx. 0.38, 0.56, and 0.75 mg/L)*.
* Calculation of concentrations (mg/L) based on Derelanko MJ (2000). Toxicologist's Pocket Handbook, CRC Press, conversion table, p. 57 - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethylhexyl acrylate
- EC Number:
- 203-080-7
- EC Name:
- 2-ethylhexyl acrylate
- Cas Number:
- 103-11-7
- Molecular formula:
- C11H20O2
- IUPAC Name:
- 2-ethylhexyl acrylate
- Details on test material:
- - Test substance: 2-ethylhexyl acrylate
- Chemical name: 2-propenoic acid, 2-ethylhexyl ester
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO Breeding Laboratories (Saint-Germain-sur-l' Arbresle, France)
- Age at study initiation: Young, nulliparous females
- Weight at study initiation: 200-220 g
- Housing: Single in clear polycarbonate cages with stainless-steel wire lids and hardwood shaving as bedding.
- Diet: Food pellets (UAR Alimentation Villemoisson, France), ad libitum
- Water: Filtered tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 50 ± 5
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- EXPOSURE
Exposures were conducted in 200-L glass/stainless-steel inhalation chambers with dynamic and adjustable laminar air flow (6-20 m3/h). The chamber temperature was set at 23 ± 2°C, and the relative humidity at 50 ± 5 %. The air-flow rate passed through the fritted disk of a heated bubbler containing the test chemical. Concentrations of acrylate ester were monitored continuously with a gas-chromatograph equipped with a flame ionization detector and an automatic gas-sampling valve. In addition, exposure levels were determined once during each 6-h exposure period by collecting atmosphere samples through glass tubes packed with activated charcoal. The charcoal samples were then desorbed with carbon disulfide. The resulting samples were analyzed by gas chromatography using appropriate internal standards. Since 2-EHA has a rather low vapour pressure (0.14 mm Hg at 20 °C), the presence of liquid particles was evaluated at the highest concentration generated (i.e. 100 ppm). Airborn particles were measured with an Aerodynamic Particle Sizer.
No differences in particle counts were observed between the clean filtered air (control) and the vapor-laden air in the exposure chambers.
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Glass/stainless-steel inhalation chambers
- Source and rate of air: Test atmospheres were generated through an additional air-flow rate passed through the fritted disk of a heated bubbler containing ethylhexyl acrylate. The vaporized compound was introduced into the main air inlet pipe of the exposure chamber.
- Air flow rate: 6-20 m3/h
TEST ATMOSPHERE
- Brief description of analytical method used: GC/FID
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical concentrations (mean ± SD):
51.0 ± 4.3 ppm (nominal: 50 ppm)
75.4 ± 9.2 ppm (nominal: 75 ppm)
102.5 ± 7.9 ppm (nominal: 100 ppm) - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/2-3
- Length of cohabitation: Overnight
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- day 6-20 of gestation
- Frequency of treatment:
- 6h /day
- Duration of test:
- until gestation day 21
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale:
Exposure concentrations were based on preliminary studies. Only minimal maternal toxicity was observed after exposure to 90 ppm ethylhexyl acrylate. Nevertheless, l00 ppm ethylhexyl acrylate was used as the highest concentration for the definitive developmental toxicity study, since preliminary level-setting studies have indicated that 100 ppm was the highest reliable vapor concentration technically possible.
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: On gestation day (GD) 0, 6, 13 and 21.
FOOD CONSUMPTION: YES
Food consumption was measured for the intervals GD 6-13 and 13-21.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: The uteri were removed and weighed. The number of implantation sites, resorptions, and dead and live fetuses were recorded. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
The number of implantation sites, resorptions, and dead and live fetuses were recorded. Uteri which had no visible implantation sites were stained with ammonium sulfide (10 %) to detect very early resorptions.
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- Live fetuses were weighed, sexed, and examined for external anomalies including those of the oral cavity. Half of the live fetuses from each litter were preserved in Bouin's solution and examined for internal soft tissue changes. The other half were fixed in ethanol (70 %), eviscerated, and then processed for skeletal staining with alizarin red S for subsequent skeletal examination.
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: all per litter - Statistics:
- Data were presented as mean ± SD. The number of implantation sites and live fetuses and the various body weights were analyzed by one-way analysis of variance (ANOVA), followed by Dunnett's test if differences were found. The percentages of non-live implants and resorptions and the proportions of fetuses with alterations in each litter were evaluated by using the Kruskal-Wallis test, followed by the Dixon-Massey test where appropriate. Rates of pregnancy, fetal sex ratio, and percentage of litters with malformations or external, visceral, or skeletal variations were analyzed by using Fisher's test. Where applicable, least-squares analysis was carried out. For all statistical tests, the level of significance was set a priori at alpha = 0.05.
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
No test dams died. Except for a significant decrease in absolute weight gain at 100 ppm, there were no significant changes in maternal weight gain of females exposed to ethylhexyl acrylate, compared of those of controls. Rats from the 100 ppm-group showed a significant decrease in food intake throughout the entire exposure period (8-11 % reduction).
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 0.56 mg/L air (nominal)
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No adverse effects were observed on the mean number of implantations and live fetuses among litters exposed to ethylhexyl acrylate. The statistically significant reductions in the incidence of non-live implants and resorptions at 50 and 100 ppm were not considered to be of toxicological significance. There was a statistically significant trend toward decreased fetal body weights, but the pairwise comparisons to the concurrent control group were not significantly different. No significant differences were observed between control and treated groups in the incidence of fetal malformations or variations.
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 0.75 mg/L air (nominal)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Maternal body weights:
Concentration [ppm/6h/d] |
Maternal body weight GD 6 [g] |
Absolute weight gain [g] |
0 |
289 ± 17 |
42 ± 11 |
50 |
294 ± 19 |
35 ± 15 |
75 |
299 ± 21 |
32 ± 18 |
100 |
292 ± 18 |
24 ± 16** |
Absolute weight gain: (Day 21 body weight) - (gravid uterus weight) - (Day 6 body weight)
Reproductive parameters:
Conc. [ppm/6h/d] |
No. of litters |
No. of implantation sites/litter |
% of non-live implants/litter |
% of resorption sites/litter |
No. of live fetuses/litter |
Average fetal body weight/litter [g] |
0 |
25 |
15.64 ± 2.87 |
10.12 ± 10.57 |
10.12±10.57 |
14.20 ± 3.57 |
5.74 ± 0.33 |
50 |
24 |
15.42 ± 4.23 |
3.65 ± 5.26* |
3.65 ± 5.26* |
14.88 ± 4.21 |
5.69 ± 0.41 |
75 |
23 |
16.30 ± 3.80 |
6.44 ± 8.26 |
6.07 ± 7.97 |
15.26 ± 3.99 |
5.58 ± 0.40 |
100 |
23 |
15.96 ± 2.46 |
3.93 ± 4.54* |
3.93 ± 4.54* |
15.30 ± 2.27 |
5.53 ± 0.31 |
Concentration [ppm/6h/d] |
0 |
50 |
75 |
100 |
Mean % of fetuses with: |
||||
- any malformations/litter |
0.27 ± 1.33 |
1.89 ± 6.91 |
0.94 ± 2.54 |
0 |
- external variations/litter |
0 |
4.41 ± 20.39 |
0 |
0 |
- visceral variations/litter |
2.46 ± 5.98 |
7.33 ± 14.90 |
8.27 ± 11.36 |
4.76 ± 10.54 |
- skeletal variations/litter |
20.62 ± 20.98 |
22.34 ± 18.63 |
17.40 ± 21.21 |
16.30 ± 15.21 |
- any variations/litter |
11.86 ± 10.96 |
19.09 ± 21.09 |
12.78 ± 11.49 |
10.62 ± 10.63 |
* ,** Significant differences from the control (0 ppm) value, p 0.05, and p 0.01, respectively.
Applicant's summary and conclusion
- Conclusions:
- In summary, no embryotoxic, teratogenic or fetotoxic properties of 2-EHA had been revealed from this study for concentrations of up to and including 100 ppm.
- Executive summary:
For the investigation with 2-EHA groups of 23 to 25 female rats were exposed (6 hours/day, whole-body) to atmospheres containing 2-ethylhexyl acrylate (99.7 % purity) at 0, 50, 75, and 100 ppm (approximately 0.38, 0.56, and 0.75 mg/L) during day 6 to day 20 of gestation. Maternal food consumption was measured for the intervals of g.d. 6-13 and of g.d. 13-21. Maternal body weights were recorded on g.d . 0, 6, 13, and 2l. Dams were sacrificed on day 21 of gestation and the uteri were removed and weighed. The number of implantation sites, resorptions, and dead and live fetuses were recorded. Uteri, which had no visible implantation sites, were stained with ammonium sulfite (10 %) for the detection of early resorptions. At sacrifice live fetuses were weighed, sexed, and examined for external anomalies including those of the oral cavity. Half of live fetuses from each litter were examined for either internal soft tissue or for skeletal changes.
There were no maternal deaths in any of the treatment groups. Dams from the 100-ppm groups showed an absolute weight gain of 24±16 g through the period of exposure, which was lower and statistically significantly different from that of the concurrent control group (42 ± 11 g). Also food intake of 24 ± 3 g food/dam/day through the period of exposure of the 100-ppm group was somewhat lower and statistically significantly different in comparison to that of the concurrent control group (27 ± 2 g food/dam/day). No adverse effects were observed on the mean number of implantation sites per litter and on the mean number of live fetuses per litter in any of the 2-EHA exposed groups. The incidences of non-live implants (3.7 - 6.4 %) and of resorption sites per litter (3.7 - 6.1 %) in the treated groups were lower than those of the concurrent control (both 10.1 %). This observation, however, is not considered to be of toxicological significance. Mean fetal body weights were slightly lower in the treated groups, however not statistically significantly different from that of the concurrent control fetuses. Sex ratio was unaffected. No significant differences were observed between the control and the 2-EHA-treated groups in the incidences of gross anomalies or of visceral or skeletal malformations or variations.
In summary, no embryotoxic, teratogenic or fetotoxic properties of 2-EHA had been revealed from this study for concentrations of up to and including 100 ppm. Due to technical limitations exposure to higher concentrations could not be tested. Based on slightly reduced food intake and lower maternal weight gain at the higher exposure level a NOAEC for maternal toxicity of 75 ppm (approximately 0.56 mg/L) was derived from this study. No embryo-/fetotoxic effects were revealed even at the highest tested concentration at which some signs of maternal toxicity had been observed. Therefore, a NOAEC for developmental toxicity of 100 ppm (approximately 0.75 mg/L) was derived from this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)