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Diss Factsheets

Administrative data

Description of key information

2-Ethylhexyl acrylate is of low toxicity after a single ingestion and virtually nontoxic after a single skin contact. The inhalation of a highly saturated vapour-air-mixture represents an unlikely acute hazard.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: scientifically acceptable study report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
BASF Test, observation period of 7 days
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Mean body weight at test start: 142.0 g
Route of administration:
oral: gavage
Vehicle:
other: aqueous emulsion with traganth (10 %)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 %
- Amount of vehicle (if gavage): 4.51 mL/kg bw


MAXIMUM DOSE VOLUME APPLIED: 5.01 mL/kg bw


Doses:
2.040, 3.160, and 5.010 mL/kg bw (corresponding to 1809.5, 2802.9, and 4443.9 mg/kg bw)
No. of animals per sex per dose:
5 animals (1809.5, 2802.9 mg/kg bw), 10 animals (4443.9 mg/kg bw)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: after 1 h, 24 h, 48 h, and 7 d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 435 mg/kg bw
Mortality:
LD50:
Original value: approx. 5.0 mL/kg bw; therefore LD50 = approx. 4435 mg/kg bw (density: 0.887 g/mL)
Clinical signs:
other: 1809.5 mg/kg bw: on the day of administration no findings; on the following day ruffled fur. 2802.9 mg/kg bw: 2 hours after administration staggering, slight abdominal position; on the following day no clinical signs apart from ruffled fur. 4443.9 mg/kg
Gross pathology:
Upon necropsy no macroscopic abnormalities were found.

Mortality:

Time

Dose level [mg/kg bw]

1809.5

2802.9

4443.9

1 h

0/5

0/5

0/10

24 h

0/5

0/5

4/10

48 h

0/5

0/5

4/10

7 d

0/5

0/5

4/10

Interpretation of results:
Category 5 based on GHS criteria
Executive summary:

Administration of 10% aqueous traganth solutions of 2-EHA (stabilised with 0.05% hydroquinone, no data on purity) to rats resulted in an oral LD50 value of 5.0 ml/kg (approximately 4,430 mg/kg). Clinical signs observed were apathy, narcotic state, and diarrhoea; no histologic alterations were detected, no further data are given.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication
Principles of method if other than guideline:
Range-finding toxicity test according to the method described by Smyth HF Jr. et al. (1962).

Smyth HF Jr. et al. (1962). Range-finding toxicity data: List VI. Amer. Ind. Hyg. Ass. J. 23: 95-107
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: no


Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
The dosages were arranged in a logarithmic series differing by a factor of two. No further data.
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Test conditions and method according to Smyth et al. (1962):
Single oral dose toxicity was estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, or in rare instances of female rats, four to five weeks of age and 90 to 120 grams. The dosages were arranged in a logarithmic series differing by a factor of two. Whenever possible, the chemical was administered undiluted. When a lesser concentration was necessary, solution in water or corn oil or suspension in semi-solid agar were the preferred expedients. Occasionally, a 1 % solution of Tergitol penetrant 7 (essentially an aqueous solution of 25 % sodium 3,9-diethyl-6-tridecanol sulfate) has been used as a dispersing agent. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range were estimated by the method of Thompson (1947).

Statistics:
The most probable LD50 value and its fiducial range were estimated by the method of Thompson (1947).

Thompson WR (1947). Use of Moving Averages and Interpolation to Estimate  Median Effective Dose. Bacteriol. Rev. 11: 115
Sex:
not specified
Dose descriptor:
LD50
Effect level:
5 766 mg/kg bw
Original value: LD50 = 6.50 mL/kg bw (confidence limits 4.72-8.95)
Based on a densitiy of 0.887 g/mL, LD50 = 5766 mg/kg bw.
Executive summary:

Within a list of range finding toxicity data a short abstract of test results is given, stating that for 2-EHA (no data on purity) an oral LD50 of 6.50 (4.72-8.95) ml/kg (approximately 5,770 mg/kg) was detected in a test with male rats (no further data available)..

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report
Principles of method if other than guideline:
Range-finding study for an in vivo cytogenetics test.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
mouse
Strain:
CD-1
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Labs
- Fasting period before study: overnight
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
0, 2500, and 5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: on the day of administration, at 24 h, 48, 72 h, 96 h, 5 d, 6 d, 7 d, and 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Two of ten CD-1 male mice died within 24 hours after dosing.
Clinical signs:
other: No significant signs of toxicity were noted in the surviving animals.
Gross pathology:
At necropsy of the two animals that had died during the course of the study, one animal showed yellow stains at the anogenital area. The other animal was without gross changes. The surviving animals showed no abnormalities at necropsy.
Executive summary:

In a test with ten male mice/dose group (2,500 mg/kg and 5,000 mg/kg, vehicle corn oil), 2-EHA (purity > 99.5%, stabilised with 10-20 ppm MMHQ) caused no mortality after administration of 2,500 mg/kg, but 2/10 mice died within 24 hours after administration of 5,000 mg/kg. Surviving animals recovered within 3 days after substance application. Clinical signs observed were scant droppings, wet yellow stained anogenital area, decreased spontaneous motor activity, ataxia, and abdominal breathing. No gross changes were detected at necropsy.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 435 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: scientifically acceptable study report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
BASF test (inhalation hazard test)
GLP compliance:
no
Test type:
other: Inhalation hazard test
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 884 g (mean)
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
1.19 mg/L
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
The vapour saturation was calculated based on the vapour pressure at 25 °C and the molecular weight.
Vapour saturation = 1.82 mg/L at 25 °C.
The assumed vapour saturation at the test temperature of 20 °C would be slightly lower than the calculated value but still greater than 1 mg/L. Thus, it can be safely concluded that the animals in the present study were indeed exposed to test substance vapours and no aerosol.
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 1.19 mg/L air (nominal)
Exp. duration:
8 h
Remarks on result:
other: IHT, saturated vapor concentration
Mortality:
No mortality was observed when 6 rats were exposed for 8 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound.
Clinical signs:
other: No clinical signs were noted during the test.
Body weight:
Body weights increased continuously.
Gross pathology:
Since the test animals showed neither clinical signs nor other abnormalities, the necropsy was omitted.
Interpretation of results:
GHS criteria not met
Executive summary:

In an inhalation hazard test, several groups of 3 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder containing approximately 120 mL of 2-EHA (stabilised with 0.05% hydroquinone, no data on purity) for 8 hours. Compressed air without further filtering was used in order to generate the test substance atmosphere. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure, which was given in the raw data, and the amount of air used during the exposure. Group-wise documentation of clinical signs was performed over the 14-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in the surviving animals. The clinical signs and findings were reported in summarized form. The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated  with volatile components of the test substance. No mortality and no clinical signs were observed in 6 animals, no more details are given.

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report
Principles of method if other than guideline:
Test conditions and method according to Smyth et al. (1962):
Concentrated vapor inhalation tests consisted of subjecting groups of six male or female albino rats to a flowing stream of vapor-ladened air. The vapor-air mixture was generated by passing 2.5 liters/minute of dried air at room temperature through a fritted glass disc immersed to a depth of at least one inch in approximately 50 mL of the test chemical contained in a gas-washing bottle. Inhalations were continued for time periods in a logarithmic series with a ratio of two extending from one-fourth to eight hours, until the inhalation period killing about half the number of rats within 14 days was defined.
GLP compliance:
no
Test type:
other: Inhalation hazard test
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
not determined
No. of animals per sex per dose:
6
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LC0
Exp. duration:
8 h
Remarks on result:
other: saturated vapor concentration at room T
Mortality:
No mortality was observed when 6 rats were exposed for 8 hours to an atmosphere that had been saturated at room temperature with the volatile parts of the compound.
Clinical signs:
other: Nasal and ocular irritation were noted.
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
GHS criteria not met
Executive summary:

In a range-finding test on ethylhexyl acrylate, substantially saturated vapour was prepared by spreading 50 g of the chemical over 200 cm² area on shallow tray placed near the top of a 120 L glass chamber at room temperature which was then sealed for at least 16 hours, while an intermittently operated fan agitated the internal chamber atmosphere. Rats were then introduced in a cage designed and operated to minimise vapour loss. After an 8-hour inhalation of that saturated 2-EHA vapour (no data on purity) none of 6 rats died within the inhalation or within the 14-day observation period after the inhalation of 2-EHA vapours. Hyperactivity on removal from exposure chamber was the only clinical sign documented, gross pathology revealed nasal and ocular irritation (Mellon Institute of Industrial Research, unpublished report, 1950).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report
Principles of method if other than guideline:
Range-finding toxicity test basically according to the method described by Smyth HF Jr. and Carpenter CP (1948).

Smyth HF Jr. and Carpenter CP (1948). Further Experience with the Range-Finding Test in the Industrial Toxicology Laboratory. J. Ind. Hyg. Toxicol. 30: 63-68
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap: impervious "Vinylite" sheeting


REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.0 and 10.0 mL/kg bw, respectively



Duration of exposure:
24 h
Doses:
5.0 and 10.0 mL/kg bw (corresponding to 4435 and 8870 mg/kg bw)
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Test conditions and method according to Smyth HF Jr. and Carpenter CP (1948):
Penetration of rabbit skin was estimated by a technique closely akin to the one-day cuff method of Draize et al. (1944) using groups of at least 6 rabbits. The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious plastic film. Dosages greater than 20 mL/kg bw could not be retained in contact with the skin. The animals were immobilized during the 24-hour contact period, after which the film was removed and the rabbits were caged for the subsequent 14-day observation period. In this study, 8 rabbits were dosed by introduction of the undiluted test substance under impervious "Vinylite" sheeting which covered their clipped trunks. The LD50 value was determined by Thompson's method.
Statistics:
The LD50 value was determined by Thompson's method.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
7 522 mg/kg bw
Mortality:
Original value: LD50 = 8.480 mL/kg
Based on a densitiy of 0.887 g/mL, LD50 = 7522 mg/kg bw.

3/4 animals succumbed to a dosage of 10 mL/kg bw (= 8870 mg/kg bw), and 4/4 survived 5.0 mL/kg bw (= 4435 mg/kg bw). The estimated LD50 calculated by Thompson's method after assuming 100 % mortality at 20 mL/kg and 100 % survival at 2.52 mL/kg bw was 8.48 mL/kg bw.
Clinical signs:
other: no data
Gross pathology:
no data
Interpretation of results:
GHS criteria not met
Executive summary:

Two groups of 4 rabbits were dosed by introduction of the undiluted ethylhexyl acrylate under impervious "Vinylite" sheeting which covered their clipped trunks. Three of 4 succumbed to a dosage of 10. ml./kg and 4 survived 5.0 ml./kg.

The estimated R.F. LD50 for rabbits by skin penetration is 8.48 ml/kg (7522 mg/kg) for the undiluted material.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication
Principles of method if other than guideline:
Range-finding toxicity test according to the method described by Smyth HF Jr. et al. (1962).

Smyth HF Jr. et al. (1962). Range-finding toxicity data: List VI. Amer. Ind. Hyg. Ass. J. 23: 95-107
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: impervious plastic film


REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 h




Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Test conditions and method according to Smyth et al. (1962):
Penetration of rabbit skin was estimated by a technique closely akin to  the one-day cuff method of Draize et al. (1944) using groups of four male albino New Zealand rabbits weighing 2.5 to 3.5 kg. The fur was removed from the entire trunk by clipping, and the dose was retained beneath an  impervious plastic film. Dosages greater than 20 mL/kg bw could not be retained in contact with the skin. The animals were immobilized during the 24-hour contact period, after which the film was removed and the rabbits were caged for the subsequent 14-day observation period. The LD50 was calculated by the method of Thompson (1947).

Statistics:
The LD50 was calculated by the method of Thompson (1947).
Sex:
male
Dose descriptor:
LD50
Effect level:
14 192 mg/kg bw
Mortality:
Original value: LD50 = 16.0 mL/kg bw (confidence limits 4.48-57.2)
Based on a densitiy of 0.887 g/mL, LD50 = 14192 mg/kg bw.
Clinical signs:
other: no data
Gross pathology:
no data
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 522 mg/kg bw

Additional information

Oral toxicity

Acute oral toxicity is characterised by LD50 values of 4,000-6,000 mg/kg. As clinical signs: scant droppings, wet yellow stained anogenital area, decreased spontaneous motoric activity and ataxia are mentioned:

 

2-EHA (stabilised with 0.05% hydroquinone, no data on purity) administration of 10% aqueous traganth solutions of the substance to rats resulted in an oral LD50 value of 5.0 ml/kg (approximately 4,435 mg/kg). Clinical signs observed were apathy, narcotic state, and diarrhoea; no histologic alterations were detected, no further data are given (BASF AG, unpublished report, 1958).

 

Within a list of range finding toxicity data a short abstract of test results is given, stating that for 2-EHA (no data on purity) an oral LD50 of 6.50 (4.72-8.95) ml/kg (approximately 5,770 mg/kg) was detected in a test with male rats (no further data available, Carpenter et al., 1974).

 

In a test with ten male mice/dose group (2,500 mg/kg and 5,000 mg/kg, vehicle corn oil), 2-EHA (purity > 99.5%, stabilised with 10-20 ppm MMHQ) caused no mortality after administration of 2,500 mg/kg, but 2/10 mice died within 24 hours after administration of 5,000 mg/kg. Surviving animals recovered within 3 days after substance application. Clinical signs observed were scant droppings, wet yellow stained anogenital area, decreased spontaneous motor activity, ataxia, and abdominal breathing. No gross changes were detected at necropsy (Rohm and Haas, unpublished report, 1982).

 

Inhalation toxicity

Valid data on acute inhalation toxicity tests are not available.

 

In an inhalation hazard test (BASF AG, unpublished report, 1958), several groups of 3 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder containing approximately 120 mL of 2-EHA (stabilised with 0.05% hydroquinone, no data on purity) for 8 hours. Compressed air without further filtering was used in order to generate the test substance atmosphere. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure, which was given in the raw data, and the amount of air used during the exposure. Group-wise documentation of clinical signs was performed over the 14-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in the surviving animals. The clinical signs and findings were reported in summarized form. The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated  with volatile components of the test substance. No mortality and no clinical signs were observed in 6 animals, no more details are given.

 

In a range-finding test on 2-EHA (Carpenter, 1950), substantially saturated vapour was prepared by spreading 50 g of the chemical over 200 cm² area on shallow tray placed near the top of a 120 L glass chamber at room temperature which was then sealed for at least 16 hours, while an intermittently operated fan agitated the internal chamber atmosphere. Rats were then introduced in a cage designed and operated to minimise vapour loss. After an 8-hour inhalation of that saturated 2-EHA vapour (no data on purity) none of 6 rats died within the inhalation or within the 14-day observation period after the inhalation of 2-EHA vapours. Hyperactivity on removal from exposure chamber was the only clinical sign documented, gross pathology revealed nasal and ocular irritation.

 

Dermal toxicity

Two groups of 4 rabbits were dosed by introduction of the undiluted 2-EHA under impervious “Vinylite” sheeting which covered their clipped trunks (Carpenter, 1950). Three of 4 succumbed to a dosage of 10.0 ml./kg and 4 survived 5.0 ml./kg. The estimated R.F. LD50 for rabbits by skin penetration is 8.48 ml/kg (7522 mg/kg) for the undiluted material.

 

A short abstract of test results given within a table, stated that for 2-EHA (no data on purity) a skin penetration LD50 of 16.00 (4.48-57.2) ml/kg (approximately 14,180 mg/kg) was detected for rabbits (Carpenter et al., 1974).  

Justification for classification or non-classification

Classification according to:

GHS classification (GHS UN rev. 7, 2017): Acute Category 5 (H303)

Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation): none