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EC number: 256-170-3 | CAS number: 44914-03-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 14 Feb 1979 - 13 Mar 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across of data for an analogous chemical. The target chemical and the source chemical are very closely related alkyl acrylate compounds. They differ only by the addition of a methyl group in the butyl portion of the molecule. Both molecules are expected to be metabolized via the same hydrolysis and enzymatic pathways. The data from the source chemical are experimental results from well documented studies which meet basic scientific principles and are considered to be acceptable with restrictions.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
- Reference Type:
- publication
- Title:
- n-Butyl Acrylate: Prenatal Inhalation Toxicity in the Rat.
- Author:
- Merkle J and Klimisch H-J
- Year:
- 1 983
- Bibliographic source:
- Fund. Appl. Toxicol. 3: 443-447
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for reproduction studies for safety evaluation of drugs for human use, FDA, Jan. 1966 and Guidance on reproduction studies from the Association of the British Pharmaceutical Industry, 1975.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- n-Butyl acrylate
- IUPAC Name:
- n-Butyl acrylate
- Reference substance name:
- Butyl acrylate
- EC Number:
- 205-480-7
- EC Name:
- Butyl acrylate
- Cas Number:
- 141-32-2
- IUPAC Name:
- butyl acrylate
- Details on test material:
- - Name of test material (as cited in study report): n-Butyl acrylate
- Analytical purity: 99.91%
- Impurities: water-0.01%, acrylic acid-0.0036%, di-n-butyl ether-0.01%, isobutyl acrylate-0.03%, methyl butyl acrylate-0.04%, hydroquinone monomethyl ether-17 ppm.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, Lyon, France
- Body weight at study initiation:
The mean body weight ± SD in dose groups 0, 25, 135 and 250 ppm were 209±12, 214±14, 214±9 and 219±16, respectively.
- Age at study initiation: 9-11 week
- Diet (e.g. ad libitum): Herilan Mrh-Zucht, H. Eggermann KG, Rinteln.
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light):12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
By means of a continuous infusion apparatus (UNITA I, B. Braun, Melsungen, Federal Republic Germany) constant amounts of the liquid product were supplied to a heated (about 80°C) evaporator. The n-butyl acrylate vapors were diluted with dust-free, conditioned fresh air and passed through 200 L inhalation chambers (all-glass construction with steel frame) under dynamic airflow conditions at a flow rate of 20 changes of air per hour (4000 L/h; 200 L chamber). A mean temperature of 24.5°C and a mean relative humidity of 53% were measured during exposure.
TEST ATMOSPHERE
- Brief description of analytical method used: The n-butyl acrylate test atmosphere concentrations were monitored analytically by means of a total
hydrocarbon analyzer (R 5 of RATFISCH, Munich). The total hydrocarbon analyzer was calibrated using an infrared analyzer Miran I (WILKS) calibrated with standards of known concentrations of n-butyl acrylate.
- Samples taken from breathing zone: yes
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analytical concentrations (Mean ± SD) of the dose groups 25, 135 and 250 ppm were 25 ± 1, 137 ± 4 and 251 ± 3 ppm, respectively.
- Details on mating procedure:
- - Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Duration of treatment / exposure:
- days 6-15 of gestation
- Frequency of treatment:
- 6 hours per day
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 135 and 250 ppm (corresponding to 0, 0.13, 0.71 and 1.31 mg/L) Calculation of concentrations (mg/L) based on Derelanko MJ (2000). Toxicologist's Pocket Handbook, CRC Press, conversion table, p. 57.
Basis:
nominal conc.
- No. of animals per sex per dose:
- 30
- Control animals:
- yes, sham-exposed
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: day on which sperm had been detected (day 0) and on the 6th, 16th and 20th days post coitum.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on the 20th day post coitum.
- Ovaries and uterine content:
- Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- The weights and the length of fetuses were determined. After fixation in Bouin's solution, 1/3 of the fetuses were examined for organ changes according to the method of Wilson and Warkany (1965), and after staining of the skeleton (Dawson, 1926) 2/3 of the fetuses were investigated for skeletal changes.
Wilson, J.G. and Warkany, J. (1965). Teratology: Principles and Techniques. The University of Chicago Press, Chicago and London.
Dawson, A.B. (1926). Stain Technol. 1:123. - Statistics:
- A trend analysis based on the generalization of the t-test according to Williams (1971, 1972) was carried out for the variables of maternal body weight and body weight gain, fetal weight and length, and placental weight in each case. The U-test (Krauth, 1971; Stucky and Vollmar, 1976) was carried out for the parameters of implantations per pregnant animal, live and dead embryos as percent per pregnant animal, and anomalies, variations and retardations as percent of live fetuses per litter.
Williams, D.A. (1971). Biometrics 27:103-117.
Williams, D.A. (1972). Biometrics 28:519-531.
Krauth, J. (1971). Ann. Math. Statist. 42:1949-1956.
Stucky, W. and Vollmar, J. (1976). J. Statist. Comput. Simul. 5:73-81.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
25 ppm were tolerated without any impairment of body weight. The body weight gain was significantly reduced after inhalation of 135 and 250 ppm during the period of treatment. In the period after the end of treatment (gd 16 - 20) the steepness of the body weight curve obtained after 135 and 250 ppm was similar to that of the control group. During the exposure 135 ppm led to distinct discharge from the eyes and noses and to ruffled fur. After inhalation of 250 ppm these symptoms were even more pronounced. No mortality occurred.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 0.13 mg/L air (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The necropsy of the animals did not reveal any gross-pathological changes of the internal organs which could be attributed to the test substance. The number of corpora lutea and the number of implantations did not show any differences between the individual groups. After inhalation of 135 and 250 ppm the percentage of live implanations per pregnant animal was dose-dependent reduced. In the 135 and 250 ppm groups, the percentage of dead resorptions were significantly increased. No adverse effect on the weight and length of the fetuses was observed. No treatment related malformations and no signs of organ changes or skeletal abnormalities were observed in the fetuses at any concentration.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 0.13 mg/L air (nominal)
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 1.31 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 weight development (mean values ± standard deviation):
Concentration [ppm] |
Maternal body weight GD 0 [g] |
Maternal body weight GD 20 [g] |
Maternal body weight gain GD 0-20 [g] |
0 |
209.38 ± 11.83 |
354.01 ± 36.66 |
144.64 ± 33.08 |
25 |
213.96 ± 13.94 |
359.62 ± 36.81 |
145.66 ± 29.87 |
135 |
213.68 ± 9.30 |
335.54 ± 43.00 |
121.87 ± 37.62* |
250 |
218.64 ± 16.19 |
318.11 ± 42.79** |
99.47± 33.68** |
* p < 0.05
** p < 0.01
Reproductive parameters:
Conc. (ppm) |
no. pregnant/ total animals |
live fetuses/ animal |
resorptions (%) |
weight of fetuses (g) |
0 |
22/30 |
11.5 ± 5.34 |
11.6 |
3.85 ± 0.41 |
25 |
23/30 |
10.6 ± 4.94 |
13.8 |
4.08 ± 0.39 |
135 |
18/30 |
8.8 ± 5.14 |
23.6* |
4.09 ± 0.23 |
250 |
19/30 |
8.4 ± 5.68 |
31.6* |
4.08 ± 0.47 |
*: p<0.05
Conc. (ppm) |
% fetuses per litter with anomalies |
% litters with fetuses showing anomalies |
% fetuses per litter with variations/ retardations |
% litters with fetuses showing variations/ retardations |
0 |
2.7 |
23.8 |
19.7 |
81.0 |
25 |
0.9 |
9.1 |
11.2 |
59.1 |
135 |
1.9 |
18.8 |
10.2 |
43.8 |
250 |
0 |
0 |
8.2 |
43.8 |
|
0 ppm |
25 ppm |
135 ppm |
250 ppm |
Skeletal findings |
||||
Anomalies: |
||||
- Cleft vertebral centra |
7/170 |
2/162 |
4/105 |
0/107 |
Variations/retardations: |
||||
- incomplete ossification of skull bone |
0/170 |
0/162 |
1/105 |
0/107 |
- aplasia of sternebrae |
16/170 |
11/162 |
3/105 |
3/107 |
-incomplete ossification of sternebrae |
30/170 |
18/162 |
14/105 |
9/107 |
- asymmetric sternebrae |
4/170 |
1/162 |
0/105 |
0/107 |
-accessory rib, bilateral |
2/170 |
3/162 |
0/105 |
0/107 |
-accessory rib, bilateral and rudimentary |
1/170 |
0/162 |
0/105 |
0/107 |
-accessory rib, unilateral and rudimentary |
1/170 |
0/162 |
0/105 |
0/107 |
-general incomplete ossification of bones |
1/170 |
2/162 |
1/105 |
1/107 |
Organ findings |
||||
Variations/retardations: |
||||
-dilatation of pelvis, unilateral |
2/82 |
0/81 |
1/54 |
0/53 |
Units given as number found/number examined
Applicant's summary and conclusion
- Executive summary:
The results presented in this summary are experimental results for the source chemical n-butyl acrylate. The results are considered to be appropriate for read-across to the target chemical 2-methylbutyl acrylate.
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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