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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

Administrative data

Description of key information

Skin contact with 2-ethylhexyl acrylate causes irritation. 2-Ethylhexyl acrylate may be irritating to the respiratory system. The substance is not irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
12 Dec 2000 - 13 Dec 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted in compliance with GLP regulations
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes
Test system:
human skin model
Vehicle:
unchanged (no vehicle)
Details on test system:
The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 uL of the test substance to a reconstructed three dimensional human epidermis model (EpiDermTM). Duplicates of the EpiDermTM tissue were incubated with the test subtance for 3 minutes and 1 hour, followed by a colorimetric determination of the possibly induced cytotoxic effect. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt. The formazan production of the test substance treated epidermal tissues is compared to the negative control tissues, calculated as relative tissue viability.

TEST SYSTEM
- The EpiDerm System consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consits of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm2) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm QS) and shipped world-wide as kits (EpiDermTM 200), containing 24 tissues on shipping agarose.
- Tissue model: Epi-200
- Origin: MatTek Corporation, Ashland MA, USA

TEST PROCEDURE
- The test was performed on a total of 4 tissues per test material, negative control and positive control. Out of these 4 tissues 2 tissues are used for the 3 minutes application and 2 tissues for the 1 hour application.
- After 3 minutes (room temperature) or after 1 hour (incubator) tissue contact with the test material, the tissues were washed with buffer to remove residual test material. Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours. After incubation tissues were washed with buffer and formazan was extracted with Isopropanol over night at room temperature. The optical density at a wavelength of 570 nm (OD570) of extracted formazan was determined spectrophotometrically and cell viability was calculated for each tissue as % of the mean of the negative control tissues. Skin corrosivity potential of the test material was classified according to remaining cell viability obtained after test material treatment with either of the 2 exposure times.

ASSAY ACCEPTANCE CRITERIA:
- Negative control (NC ): mean OD570 of the NC per exposure time > = 0.8
- Positive control (PC ): mean relative tissue viability of the 3 min positive control is <= 30 %
- Tissue variability: The inter tissue variability is considered to be acceptable if the difference of the OD570 values of
the two tissues is <= 0.3
- Killed controls (KC ): OD570 of the killed control tissues treated as negative control should be <= 0.35
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50 µL
Duration of treatment / exposure:
3 min and 1h
Duration of post-treatment incubation (if applicable):
none
Number of replicates:
2 per exposure time
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3-min exposure
Value:
99
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: not corrosive
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1-h exposure
Value:
104
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: not corrosive

Exposure: 3 min

Test article

Mean OD570

Viability [% of NC]

NC

1.621

100

TS

1.600

99

PC

0.237

15

Exposure: 1 h

Test article

Mean OD570

Viability [% of NC]

NC

1.593

100

TS

1.663

104

PC

0.182

11

NC = Negative control

TS = Test substance

PC = Positive control

Interpretation of results:
other: not corrosive
Conclusions:
Based on the observed results it was concluded, that the test substance does not have a corrosive potential in the EpiDerm skin corrosivity test under the test conditions chosen.
Executive summary:

In order to support the decision if the local lesions caused after skin contact are to be classified as corrosion or as severe irritation, BASF AG carried out an alternative to the Draize skin test which was developed in order to differentiate between irritation and corrosion (EU Guideline B.40). The so called EpiDermTM Skin Corrosivity Test was performed using 2-ethylhexyl acrylate, purity 99.7%. The potential of 2-EHA to cause dermal corrosion was assessed by a single topical application of 50 µl of the test substance to a reconstructed three dimensional human epidermal model (EpiDermTM). Dublicates of the EpiDermTM tissue were incubated with 2-EHA for 3 minutes and 1 hour, followed by a colorimetric determination of the possibly induced cytotoxic effects. Viability of the test substance treated tissues determined after an exposure period of 3 minutes was 99% and for the exposure period of 1 hour 104% (2-EHA is not able to directly reduce MTT, the indicator used for detection of cytotoxicity). It is demonstrated that 2-EHA reacts like the negative control, while a caustic compound used as positive control proved that this system is able to detect caustic chemicals. Based on the observed results and applying the evaluation criteria of the test, 2-EHA does not have a corrosive potential in this test under the conditions chosen.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles
Principles of method if other than guideline:
BASF Test: 2 white Vienna rabbits were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, 6050 Offenbach, Germany
- Weight at study initiation: approx. 3.1 kg (mean)
- Sex: male / female
- Diet (ad libitum): Ssniff-K-standard diet/rabbit Intermast, Soest
- Water (ad libitum): tap water
Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
other: none
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): undiluted, no amount specified



Duration of treatment / exposure:
1 min, 5 min, 15 min, and 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patch, no further data


REMOVAL OF TEST SUBSTANCE
- Washing: yes (exposure 1, 5, 15 min) first with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %); no (exposure 20 h)
- Time after start of exposure: 1, 5, and 15 min, respectively


SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Irritation parameter:
erythema score
Remarks:
Exposure time: 15 min
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
erythema score
Remarks:
Exposure time: 15 min
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
edema score
Remarks:
Exposure time: 15 min
Basis:
animal: #1 and 2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
Exposure time: 20 h
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: 1st trial
Irritation parameter:
erythema score
Remarks:
Exposure time: 20 h
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within:
Remarks:
8 d
Remarks on result:
other: 1st trial
Irritation parameter:
edema score
Remarks:
Exposure time: 20 h
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: 1st trial
Irritation parameter:
edema score
Remarks:
Exposure time: 20 h
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: 1st trial
Irritation parameter:
erythema score
Remarks:
Exposure time: 20 h
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: 2nd trial
Irritation parameter:
erythema score
Remarks:
Exposure time: 20 h
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: 2nd trial
Irritation parameter:
edema score
Remarks:
Exposure time: 20 h
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: 2nd trial
Irritation parameter:
edema score
Remarks:
Exposure time: 20 h
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 2nd trial
Irritant / corrosive response data:
Mean erythema score after 24, 48 and 72 h (2 animals):

Exposure time 24 h 48 h 72 h mean
1 min 1/2 1/1 0/0 0.7/1.0
5 min 2#/2 2#/1 0/0 1.3/1.0
15 min 3/2* 2/2#* 1#/1# 2.0/1.7
20 h 3/3 3#/3#** 2#/3#** 2.7/3.0
20 h (2) 3/2 2/2 2/2 2.3/2.0


Mean edema score after 24, 48 and 72 h (2 animals):

Exposure time 24 h 48 h 72 h mean
1 min 0/0 0/0 0/0 0/0
5 min 0/0 0/0 0/0 0/0
15 min 0/0 0/0 0/0 0/0
20 h 2/2 0/2 0/2 0.7/2.0
20 h (2) 3/2* 0/0 0/0 0.7/1.0

* findings extending beyond the area of application
** findings extending beyond the area of application / livid
# blotchy


Findings after 8 days (2 animals):

Exposure time Skin finding
1 min -
5 min -
15 min Desquamation/slight desquamation
20 h Desquamation
20 h (2) Desquamation

(2): Second trial with direct comparison of four acrylates
Based on the presented test results, ethylhexyl acrylate can be considered to be a skin irritant.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Executive summary:

In a test conducted according to an internal method by BASF AG, 2-ethylhexyl acrylate (no data on purity) caused moderate erythema after a 1 minute and after a 5 minute exposure time under occlusion which reversed within 72 hours. After an exposure time of 15 minutes under occlusive conditions severe erythema with scaling after 8 days were observed and severe erythema (mean scores over 24 -48 -72 h: 2.8) and moderate edema (mean scores over 24 -48 -72 h: 1.3) appeared within 24 hours after a 20-hour exposure time. Eight days after application desquamation was stated (BASF AG, 1978). A second trial was conducted with 20-hour exposure under occlusion and direct comparison of 4 acrylates. Moderate-severe erythema and slight edema were observed with mean scores over 24 -48 -72 h of 2.2 for erythema and 0.8 for edema. At the end of the oberservation time (8 d) desquamation was again reported.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles
Qualifier:
equivalent or similar to guideline
Guideline:
other: Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register -29 F.R. 13009, 1964.
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: one side of each rabbit back was abraded and one side remained intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 1 inch X 1 inch
- Type of wrap if used: square surgical gauze patches


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize Score / Federal Register Method
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24-72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritant / corrosive response data:
The primary irritation score was determined to be 5.0 indicating the potential of the substance to be a primary skin irritant. According to the Draize score, 2-ethylhexyl acrylate was found to be a moderate to severe primary irritant.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Executive summary:

In an occlusive patch test according to US Federal Register Guideline of 1964 four rabbits were tested with 0.5 ml of 2-EHA (no data on purity) each, using 24 hours occlusive exposure to intact and abraded skin. Mean scores (24 hours/72 hours) for erythema of 1.75/2 and for oedema of 3.25/3.25 were observed for intact skin, for abraded skin the same scores were obtained. No indication of necrotic effects are mentioned both in intact and abraded skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Swedish report, short abstract in english and tables comprehensible, text partially translated
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the undiluted test material
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
Comment: rinsed after (see exposure time)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h


Irritation parameter:
cornea opacity score
Basis:
animal: #1 and 2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and 3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1 and 2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Based on the results of the present study, 2-ethylhexyl acrylate was classified by the authors as non-irritating to the eye.
        Cornea		Iris		      Conjunctivae
					Erythema	Chemosis
-----------------------------------------------------------------
1 h	0/0/0		0/0/1		0/1/1		0/1/1
24 h	0/0/1		0/0/0		0/0/1		0/0/1
48 h	0/0/0		0/0/0		1/0/0		0/0/0
72 h	0/0/0		0/0/0		0/0/0		0/0/0
-----------------------------------------------------------------

Interpretation of results:
GHS criteria not met
Executive summary:

In a test according OECD test guideline 405 and performed under GLP, 2-EHA (purity 98%) caused mild eye irritation: 0.1 ml of the substance was instilled into the eyes of 3 Albino rabbits, the following mean scores are documented for the 24, 48 and 72 observation times: cornea 0/0/0.3, iris 0/0/0.3, conjunctival redness 0.3/0/0.3, conjunctival chemosis 0/0/0.3. All signs of irritation were reversible within 3 days (Koch et al., 1985).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: scientifically acceptable study report
Principles of method if other than guideline:
BASF Test before OECD Guideline 405 was established, eye irritation was tested using an internal method
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.17 kg (mean)
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated adjacent eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL of the undiluted test material
Duration of treatment / exposure:
9 d
Observation period (in vivo):
9 d
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed


SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1 and 2
Time point:
24/48 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and 2
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1 and 2
Time point:
24/48 h
Score:
0
Max. score:
2
Eye irritation scores for the single animals (animal 1/2):

Findings after   erythema   chemosis   opacity   iritis 
-----------------------------------------------------------     
    1 h            2/2        1/0        0/0      0/0
   24 h            1/0        0/0        0/0      0/0    
   48 h            0/0        0/0        0/0      0/0    
    5 d            0/0        0/0        0/0      0/0       
    9 d            0/0        0/0        0/0      0/0    
-----------------------------------------------------------

Mean values over 24 and 48 hours:

Animal 1: Erythema: 0.5, Chemosis: 0, Opacity: 0, Iritis: 0
Animal 2: Erythema: 0, Chemosis: 0, Opacity: 0, Iritis: 0

Based on the presented data, 2 -ethylhexyl acrylate is not irritating to the rabbit eye.


Interpretation of results:
GHS criteria not met
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles.
Qualifier:
equivalent or similar to guideline
Guideline:
other: Federal Hazardous Substances Labelling Act Regulations, Section 191.12, published in the Federal Register -29 F.R. 13009, 1964.
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-2 .5 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent, untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Readings were performed after 24, 48, and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Federal Register Method


TOOL USED TO ASSESS SCORE: ophthalmoscope, fluoroscein sodium
Irritation parameter:
cornea opacity score
Basis:
animal: #1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1 to 6
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: #2, 3 and 5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #1, 2, 3, 5 and 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Either slight or well-defined injection of ttie vessels of the conjunctivae and one example of slight swelling were exhibited by the test group of rabbits during the observation .period . No corneal or iris lesions were identified in any animal.
Interpretation of results:
GHS criteria not met
Executive summary:

Moderate conjunctival irritation, but no lesions on cornea or iris resulted in an ocular irritation test according to US Federal Register Guideline of 1964. Instillation of 0.1 ml of 2-EHA (no data on purity) into the eyes of 6 rabbits resulted in either slight or well-defined injection of the vessels of the conjunctivae, one example of slight swelling was exhibited (scores after 24, 48, and 72 hours are stated to exist, but no information on these scores is available). The observation

period is not mentioned. No corneal or iris lesions were identified in any animal. Since only 1/6 rabbits displayed a reaction which would be considered to be positive according to US regulations of 1964, the test was regarded as being negative (Poole, 1980).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

There is no skin irritation study performed according to the current guidelines. The skin irritation potential of 2-EHA was therefore evaluated on a weight of evidence basis.

 

In a test conducted according to an internal method by BASF AG, 2-EHA (no data on purity) caused moderate erythema after a 1 -minute and after a 5 -minute exposure time under occlusion which reversed within 72 hours. After an exposure time of 15 minutes under occlusive conditions severe erythema with scaling after 8 days were observed and severe erythema (mean scores over 24 -48 -72 h: 2.8) and moderate edema (mean scores over 24 -48 -72 h: 1.3) appeared within 24 hours after a 20-hour exposure time. Eight days after application desquamation was stated (BASF AG, 1978). A second trial was conducted with 20-hour exposure under occlusion and direct comparison of 4 acrylates. Moderate-severe erythema and slight edema were observed with mean scores over 24 -48 -72 h of 2.2 for erythema and 0.8 for edema. At the end of the oberservation time (8 d) desquamation was again reported.

 

In an occlusive patch test according to US Federal Register Guideline of 1964 four rabbits were tested with 0.5 ml of 2-EHA (no data on purity) each, using 24 hours occlusive exposure to intact and abraded skin. Mean scores (24 hours/72 hours) for erythema of 1.75/2 and for oedema of 3.25/3.25 were observed for intact skin, for abraded skin the same scores were obtained. No indication of necrotic effects are mentioned both in intact and abraded skin (Poole, 1980).

 

In order to support the decision if the local lesions caused after skin contact are to be classified as corrosion or as severe irritation, an EpiDermTM Skin Corrosivity Test was performed using 2-EHA, purity 99.7% (BASF, 2001). The potential of 2-EHA to cause dermal corrosion was assessed by a single topical application of 50 µl of the test substance to a reconstructed three dimensional human epidermal model (EpiDermTM). Dublicates of the EpiDermTM tissue were incubated with 2-EHA for 3 minutes and 1 hour, followed by a colorimetric determination of the possibly induced cytotoxic effects. Viability of the test substance treated tissues determined after an exposure period of 3 minutes was 99% and for the exposure period of 1 hour 104% (2-EHA is not able to directly reduce MTT, the indicator used for detection of cytotoxicity). It is demonstrated that 2-EHA reacts like the negative control, while a caustic compound used as positive control proved that this system is able to detect caustic chemicals. Based on the observed results and applying the evaluation criteria of the test, 2-EHA does not have a corrosive potential in this test under the conditions chosen.

Taking all valid study results into account, 2-ethylhexyl acrylate should be classified as a skin irritant.

 

Eye irritation

In a test according OECD test guideline 405 and performed under GLP, 2-EHA (purity 98%) caused mild eye irritation: 0.1 ml of the substance was instilled into the eyes of 3 Albino rabbits, the following mean scores are documented for the 24, 48 and 72 observation times: cornea 0/0/0.3, iris 0/0/0.3, conjunctival redness 0.3/0/0.3, conjunctival chemosis 0/0/0.3. All signs of irritation were reversible within 3 days (Koch et al., 1985).

 

BASF AG conducted an eye irritation test on rabbits following an internal study protocol. In deviation to today’s standards, the rabbit eyes were not washed out. Eye reactions were scored after 1, 24 and 48 hours, and after 5 and 9 days. After 1 hour erythema and edema were observed which had completely reversed within 48 hours in both animals (BASF AG 1958). Based on these data, 2 -ethylhexyl acrylate is not irritating to the rabbit eye.

 

Moderate conjunctival irritation, but no lesions on cornea or iris resulted in an ocular irritation test according to US Federal Register Guideline of 1964. Instillation of 0.1 ml of 2-EHA (no data on purity) into the eyes of 6 rabbits resulted in either slight or well-defined injection of the vessels of the conjunctivae, one example of slight swelling was exhibited (scores after 24, 48, and 72 hours are stated to exist, but no information on these scores is available). The observation period is not mentioned. No corneal or iris lesions were identified in any animal. Since only 1/6 rabbits displayed a reaction which would be considered to be positive according to US regulations of 1964, the test was regarded as being negative (Poole, 1980).

 

Respiratory irritation

There exists no standard test method for the assessment of respiratory irritation. Thus, the labelling of 2-EHA with “H335, Irritating to respiratory tract” according to current EU regulations is not based on results of a specific respiratory irritation test, but on considerations on the general irritation potential of 2-EHA (nasal and ocular irritation noted in a test on acute inhalation toxicity with rats, severe local irritation potential detected on the skin and slight irritation potential detected on the conjunctivae of rabbits; serious lesions as seen after repeated inhalation of 2-EHA may well be initiated i.a. by primary respiratory irritation).

Justification for classification or non-classification

Classification according to GHS classification (GHS UN rev.7, 2017) identical to REGULATION (EC) No 1272/2008:

- Skin corrosion/irritation: Category 2 (H315 Cause skin irritation)

- Serious eye damage/eye irritation: no classification required

- Specific target organ toxicity, Single exposure: Category 3 (H335 May cause respiratory irritation)