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EC number: 219-698-5 | CAS number: 2499-95-8
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
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
- 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. Control animals were exposed concurrently to filtered room air. The test concentrations of n-butyl acrylate were 100, 200, and 300 ppm (corresponding to approx. 0.52, 1.05, and 1.57 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:
- Butyl acrylate
- EC Number:
- 205-480-7
- EC Name:
- Butyl acrylate
- Cas Number:
- 141-32-2
- Molecular formula:
- C7H12O2
- IUPAC Name:
- butyl acrylate
- Details on test material:
- - Test substance: n-butyl acrylate
- Analytical Purity: > 99 %
- Supplier: Aldrich Chemical Co. (Milwaukee, WI)
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.
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):
103.3 ± 6.7 ppm (nominal: 100 ppm)
202.8 ± 9.7 ppm (nominal: 200 ppm)
302.5 ± 10.1 ppm (nominal: 300 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:
- days 6 to 20 of gestation
- Frequency of treatment:
- 6 hours/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 in which marked decreases in maternal weight gain were observed at 200 and 300 ppm of butyl acrylate. Results from previous prenatal inhalation toxicity studies on butyl acrylate were also considered (Merkle and Klimisch, 1983). The high concentrations of butyl acrylate for the definitive study (200 and 300 ppm, respectively) were chosen to maximize the opportunity of identifying embryolethal or teratogenic potential.
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.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- During the entire exposure period, maternal weight gain was signifciantly reduced at 200 ppm and 300 ppm compared to the control group. Absolute weight gains (expressed as the day 21 body weight minus the gravid uterus weight and minus the day 6 body weight) were reduced in a dose-rependent manner in all exposure groups.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Decreases in food consumption was observed during the first half of the study for the females in the 100 ppm dose group and throught the exposure period at 200 and 300 ppm. The maximum decrease was 40-50% at the highest concentration.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- 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:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- ca. 0.52 mg/L air (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Fetal body weight was significantly reduced at 200 ppm (for both sexes combined and males) and at 300 ppm (both sexes combined, males and females). These decreases amounted to 7-8 % (p<0.05) and 26-28 % (p<0.01) of control values for the 200 and 300 ppm groups, respectively.
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- A few sporadic malformations were seen in the 300 ppm and the control group. The incidence of individual skeletal variations (mainly incomplete ossification of sternebrae and of vertebral centra) was similar in the control and treated groups.
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 0.52 mg/L air (nominal)
- Basis for effect level:
- other: fetotoxicity
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 1.57 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 |
294 ± 23 |
32 ± 15 |
100 |
289 ± 23 |
18 ± 14* |
200 |
299 ± 24 |
-16 ± 20** |
300 |
292 ± 23 |
-60 ± 26** |
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 |
15.68 ± 3.17 |
10.9 ± 15.49 |
10.64±15.62 |
14.12 ± 4.01 |
5.74 ± 0.43 |
100 |
24 |
15.58 ± 3.05 |
6.82 ± 10.19 |
6.82 ± 10.19 |
14.71 ± 3.57 |
5.71 ± 0.35 |
200 |
24 |
15.08 ± 4.23 |
4.72 ± 5.96 |
4.72 ± 5.96 |
14.46 ± 4.20 |
5.33 ± 0.40* |
300 |
25 |
15.40 ± 5.24 |
6.48 ± 15.94 |
6.48 ± 15.94 |
14.68 ± 5.38 |
4.25 ± 0.94** |
Concentration [ppm/6h/d] |
0 |
100 |
200 |
300 |
Mean % of fetuses with: |
||||
- any malformations/litter |
2.00 ± 7.33 |
0 |
0 |
0.62 ± 2.65 |
- external variations/litter |
1.33 ± 6.67 |
0 |
0 |
0.22 ± 1.11 |
- visceral variations/litter |
8.81 ± 14.64 |
0 |
0 |
4.17 ± 20.41 |
- skeletal variations/litter |
13.70 ± 15.48 |
17.01 ± 14.53 |
18.71 ± 24.21 |
24.65 ± 20.69 |
- any variations/litter |
12.60 ± 10.80 |
13.27 ± 15.07 |
10.10 ± 10.32 |
15.90 ± 19.98 |
* ,** Significant differences from the control (0 ppm) value, p 0.05, and p 0.01, respectively.
Applicant's summary and conclusion
- Executive summary:
In a developmental toxicity study, pregnant Sprague-Dawley female rats (20-29 per dose) were exposed to the compound 6h/day on days 6 through 20 of gestation. Control animals were exposed concurrently to filtered room air. The test concentrations of n-butyl acrylate were 100, 200, and 300 ppm (corresponding to approx. 0.52, 1.05, and 1.57 mg/L). Significant decreases in maternal body weight gain were observed at 200 ppm and 300 ppm, and decreased absolute weight gain were observed in all dose groups through the entire exposure period. Decreased fetal body weight was observed at 200 ppm (7-8%) and 300 ppm (26-28%) in the presence of significant maternal toxicity. No significant increases in malformations was observed in n-butyl acrylate exposed fetuses.
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