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EC number: 219-606-3 | CAS number: 2478-10-6
- 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
Endpoint summary
Administrative data
Description of key information
Test substance is irritating to skin and corrosive to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive conditions; readings after 72 hrs missing, only two animals tested
- Principles of method if other than guideline:
- Occlusive conditions were used during exposure. Reading after 72 h is missing and only two animals were tested.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Butanediolmonoacrylate
- Chemical name: 2-Propenoic acid, 4-hydroxy ester
- Analytical purity: >= 94 %
- Substance No.: 77/759 - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach / Main, Germany
- Sex: male
- Age at study initiation: no data
- Mean body weight at study initiation: males 3.0 kg
- Diet (ad libitum): Ssniff K, standard diet for rabbits, INTERMAST GmbH, Soest, Germany
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
no details given - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- 15 - 24 hrs before test start
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin areas of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours or 5 min
- Observation period:
- 8 days
- Number of animals:
- 2 per timepoint
- Details on study design:
- 4 h exposure:
TEST SITE
- Area of exposure: flank and back, 2 x 2 cm
- Type of wrap if used: the test patch which was wetted with the test substance was applied to the dorsal skin of the rabbits by means of a gummed linen patch that was fastened by an adhesive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lutrol or lutrol:water (1:1)
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Draize Scoring System (1959)
5 min exposure:
TEST SITE
- Area of exposure: flank and back, 2.5 x 2.5 cm
- Type of wrap if used: the test patch which was wetted with the test substance was applied to the dorsal skin of the rabbits by means of a gummed linen patch that was fastened by an adhesive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol or lutrol:water (1:1)
- Time after start of exposure: 5 min
SCORING SYSTEM: Draize Scoring System (1959)
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (4h exposure)
- Time point:
- 24/48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: findings extending far beyond the area of application
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (4h exposure)
- Time point:
- 24/48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: findings (ery., ed.) extending beyond the area of application
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (4h exposure)
- Time point:
- 24/48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: findings (ery., ed.) extending beyond the area of application
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (4h exposure)
- Time point:
- 24/48 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: findings (ery., ed.) extending beyond the area of application
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2
- Remarks:
- (5 min exposure)
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2
- Remarks:
- (5 min exposure)
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Application for 4 hours produced marked erythema (grade 3) and slight to very strong edema (grades 2-4) in 2/2 rabbits (observed at 4, 24 and 48 hours). After 8 days, slight erythema (grade 2) and slight edema (grade 2) still persisted in 2/2 and 1/2 rabbits, respectively. Scaling respectively severe scaling was observed in both animals. Corrosive effects in form of necrosis were not observed in any animal.
Both animals did not show a local irritation reaction upon 5 min exposure to the test substance. - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
Reference
Raw data for 4 h exposure:
Readings |
Animal No. |
Erythema |
Edema |
Additional findings |
4 h |
1 |
3 |
4 |
findings (ery., ed.) extending far beyond the area of application |
|
2 |
3 |
3 |
findings (ery., ed.) extending beyond the area of application |
24 h |
1 |
3 |
4 |
findings (ery., ed.) extending far beyond the area of application |
|
2 |
3 |
3 |
findings (ery., ed.) extending beyond the area of application |
48 h |
1 |
3 |
2 |
findings (ery., ed.) extending far beyond the area of application, severe desquamation |
|
2 |
3 |
2 |
findings (ery., ed.) extending beyond the area of application |
8 d |
1 |
2 |
0 |
scaling |
|
2 |
2 |
2 |
findings (ery., ed.) extending beyond the area of application, severe scaling |
No effects were visible following a 5 min application.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Fed. Reg. 28 (119): 5582, 1963
- Deviations:
- not specified
- Principles of method if other than guideline:
- Draize Test: In general, the techniques of tests as published by the FDA of the United States (Fed. Reg. 28 (119): 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71: 36, 1952) were followed. Only an observation period of up to 7 days was examined.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material: Butanediolmonoacrylate
- Chemical name: 2-Propenoic acid, 4-hydroxy ester
- Analytical purity: >= 94 %
- Substance No.: 77/759 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: no data
- Weight at study initiation: no data
- Housing: one animal/cage
- Diet (ad libitum): They received no hay or other extraneous material that might have entered the eyes.
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
no details given
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remaining untreated, served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- once
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
- According to Draize and Kelly (Drug . Cosmet . Industr . 71 (1952) 36) - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- other: animal died after 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Ulcus corneae was found after 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: animal died after 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Ulcus corneae was found after 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- other: animal died after 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Ulcus corneae was found after 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: animal died after 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Ulcus corneae was found after 7 days
- Irritant / corrosive response data:
- The test substance caused moderate to severe corneal damage, slight iritis and severe lesions of the conjunctivae. One rabbit died in the course of the observation period; the death occurred between the 72-hour reading and the 7-day reading; however, the cause of death was not considered to be substance-related. Another rabbit showed an ulcer of the cornea at the 7th day; according to the authors, this may be treatment-related.
According to the authors, the test substance was severely irritating to the eyes. Eye irritation score was 69 (maximum eye irritation index = 110). - Other effects:
- One rabbit died in the course of the observation period; the death occurred between the 72-hour reading and the 7-day reading; however, the cause of death was not considered to be substance-related.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
Reference
Individual eye irritation scores:
Time |
Rabbit no. |
Cornea |
Iris |
Conjunctivae |
Total score |
|||
|
|
Opacity |
Area |
|
Redness |
Chemosis |
Discharge |
|
1 hr |
1 |
0 |
0 |
0 |
2 |
4 |
2 |
16 |
2 |
1 |
4 |
1 |
2 |
4 |
2 |
41 |
|
3 |
1 |
4 |
1 |
2 |
3 |
2 |
39 |
|
24 hr |
1 |
2 |
4 |
1 |
2 |
3 |
3 |
61 |
2 |
2 |
4 |
1 |
2 |
4 |
3 |
63 |
|
3 |
3 |
4 |
1 |
2 |
4 |
3 |
83 |
|
48 hr |
1 |
2 |
4 |
1 |
2 |
3 |
2 |
59 |
2 |
2 |
4 |
1 |
2 |
3 |
3 |
61 |
|
3 |
3 |
4 |
1 |
2 |
3 |
3 |
81 |
|
72 hr |
1 |
3 |
4 |
1 |
2 |
3 |
2 |
79 |
2 |
2 |
4 |
1 |
2 |
2 |
2 |
57 |
|
3 |
3 |
4 |
1 |
2 |
3 |
2 |
79 |
|
7 d |
1* |
- |
- |
- |
- |
- |
- |
- |
2 |
3 |
4 |
1 |
2 |
2 |
0 |
71 |
|
3** |
4 |
3 |
1 |
2 |
2 |
3 |
79 |
* dead
** Rabbit no. 3 showed an ulcus corneae
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation
Several studies demonstrated that undiluted 4-hydroxybutyl acrylate is severely irritating to skin.
Key study
In a study comparable to OECD TG 404, 0.5 mL of the undiluted test substance was applied to the intact dorsal skin (2.0 cm x 2.0 cm) of 2 White Vienna rabbits under occlusive conditions (BASF, 1979). The test material was applied to 2 rabbits for 4 hours and to two rabbits for 5 min. At the end of the exposure period, the application sites were washed with Lutrol or Lutrol:water 1:1. The application sites were scored according to the Draize scale (maximum grade = 4) immediately after removal of the test patch, and at 24 hours, 48 hours and 8 days after beginning of the application. Untreated skin areas of the same animals served as negative controls. The application for 5 min produced no local irritation reaction. Application for 4 hours produced marked erythema (grade 3) and slight to very strong edema (grades 2-4) in both rabbits (observed at 4, 24 and 48 hours). After 8 days, slight erythema (grade 2) and slight edema (grade 2) still persisted in 2/2 and 1/2 rabbits, respectively. Scaling respectively severe scaling was observed in both animals. However, necrosis was not observed in both rabbits, indicating that the test substance is irritating rather than corrosive.
Supporting study
In a study comparable to OECD TG 404 , undiluted test substance was applied to the skin of White Vienna rabbits with an occlusive covering for three minutes (2 rabbits), one (4 rabbits) and four hours (2 rabbits), respectively (BASF, 1981). After the application time of 3 minutes, mean erythema scores (24 and 48 hours) were 0 and 2, and mean edema scores were 0 and 1, respectively. At test termination after 8 days, one animal showed desquamation, whereas the other rabbit was without findings. Application for 1 hour produced mean erythema scores (24 and 48 hours) of 1.5, 3, 1, and 2, and mean edema scores of 1, 3, 0, and 1.5, respectively. After 8 days, 2 of 4 rabbits showed superficial or patchy necrosis besides erythema and edema. The third animal showed erythema and scaling. No skin irritation was observed in the fourth animal after 8 days. The superficial respectively patchy necrosis observed in 2 of 4 rabbits was confirmed by gross-pathological examination. After the test substance application for 4 hours, mean erythema scores (24 and 48 hours) were 2 and 2, and mean edema scores were 2.5 and 2.5, respectively. Patchy necrosis of the skin was observed after 8 days in both animals; this finding was confirmed by gross-pathological examination. As the necrosis observed did not reach the dermis, the substance is classified as severely irritating (and not corrosive).
In an in vitro EpiDerm Skin Corrosion / Irritation Test (BASF, 2013) it was concluded, that that 4-hydroxybutyl acrylate shows a skin irritation potential.
Eye irritation
Key study
A Draize test was performed in three New Zealand White rabbits by TNO for BASF (1978). 100 microlitres of the undiluted test substance (4 -hydroxybutyl acrylate) were instilled in the conjunctival sac of one eye. The other eye remaining untreated, served as a control. The eyes were not washed following instillation. The eyes were examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material. The test substance caused moderate to severe corneal damage, slight iritis and severe lesions of the conjunctivae. One rabbit showed an ulcer of the cornea at the 7th day; according to the authors, this may be treatment-related. Mean scores from the readings at 24, 48, and 72 hours were: cornea 2.4, iris 1.0, conjunctivae 2.0, and chemosis 3.1. These effects were not reversible within the observation period of 7 days (BASF AG, 1978).
Supporting study
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits (Gaukler) were used. Initial body weights were at test start 2.62 kg (male) and 2.37 kg (female). 50 µL of 4 -hydroxybutyl acrylate were applied to the conjunctival sac of one eye in 2 animals. The saline-treated adjacent eyes served as control. The animals were observed several times on the day of treatment and up to 8 days afterwards. Findings were recorded on working days. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 and 120 hours from the raw data were also taken into account. The original BASF grading was converted into the numerical grading according to the OECD Draize system. At the 1-hour reading, slight redness, moderate edema and smeary overlays were observed. At the 24-hour reading, moderate redness, moderate edema, moderate corneal opacity, hemorrhages of the nictitating membrane and smeary overlays were noted. After 8 days, moderate redness, slight edema, moderate corneal opacity, vascularization, staphyloma, scars, smeary overlays and alopecia were present. The control eyes were without any sign of ocular irritation.
Respiratory irritation
There exists no standard test method for the assessment of respiratory irritation. The inhalation hazard test available for 4-hydroxybutyl acrylate did not give any evidence that test substance vapours may be irritating to the nose and respiratory tract of rats (BASF, 1976). In comparison to its structural analogues 2-hydroxyethyl acrylate (CAS 818-61-1) and hydroxypropyl acrylate (CAS 25584-83-2) which were demonstrated to cause respiratory irritation in rats and humans, 4-hydroxybutyl acrylate shows a lower vapour pressure (0.005 hPa).
Justification for classification or non-classification
Based on the results the test substance has to be classified as Skin Irrit. 2, H315 (Causes skin irritation) and Eye Damage 1, H318 (Causes serious eye damage) in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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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