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Diss Factsheets

Administrative data

Description of key information

Acrylic acid is highly corrosive to skin and eyes. Acrylic acid may be irritating/corrosive to the respiratory tract.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin 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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): acrylic acid glacial.
- Analytical purity: 99.8% pure (determined by GC)
- Lot/batch No.: Tank 8
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr . K . Thomae GmbH, Biberach, FRG (animals 01, 02, 03 ), Boehringer Ingelheim Pharma KG (animals 04, 05)
- Age at study initiation: Young adult animals
- Housing: Single housing
- Diet (e.g. ad libitum): Kliba-Labordiaet, Klingentalmuehle AG, Kaiseraugst, Switzerland.
- Water (e.g. ad libitum): Tap water
- Acclimation period: Acclimatization for at least 1 week .



Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin sites of the same animal.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:
3 minute(s)
Observation period:
1 h and 14 d
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: Upper third of the back or flanks.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol(R)** and Lutrol(R)/water (1 :1) .
- Time after start of exposure: 3 min.


** Lutrol(R) E 400 = Polyethylenglycol DAB, BASF AG

SCORING SYSTEM: OECD TG 404 was used.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Other effects:
Tests with animals 01 and 03 were discontinued because of severe irritation. The finding was assessed by macroscopic pathology indicating superficial necrosis and slight edema (animal 03) and discolouration of the application area (animal 01).
Gross- and histopathological examination of the skin of animal 02 was not performed.

Histopathological examination :
Animal 01 : Left flank : Severe swelling of collagen fibres in dermis and subcutis and pyknoses in the basal cell layer
Animal 03 : Left flank : Epidermal coagulation necrosis with edematous swelling of the dermis (no full thickness necrosis)
Animal 04 and 05 : Left flank : Focal deep necrosis (full thickness necrosis), loss of the epidermal adnexa in necrosis area, perifocal moderate epithelial hyperplasia , diffuse inflammatory reaction (corium to subcutis) in the application area.

Table 1: Results

Animal

Reading

Erythema

Edema

Comment

01

1h

-

2

-

02

1h

2

3

Erythema and Edema extending beyond the area of exposure

03

1h

-

3

­

04

1h

3

3

Erythema and Edema extending beyond the area of exposure

05

1h

3

3

Erythema and Edema extending beyond the area of exposure

Under the test conditions chosen and considering the described findings Acrylic acid glacial gives indication of causing full thickness destruction of skin tissue as a result of an exposure period of 3 minutes, when observation period is extended to 14 days, but not within an observation period of 1 hour .

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF-Test: Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. One drop of the test substance was applied to the conjunctival sac of the right eye of the animal. The adjacent eye was treated with one drop of physiological solution of sodium chloride and served as a control.The animals were observed several times on the treatment day and 8 days afterwards, and findings were recorded on working days.
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Acrylic acid, raw, stabilised with approx. 0.2% phenothiazon.
- Analytical purity: 86%
- Composition of test material, percentage of components: Acrylic acid 86%, 2-propenoic acid, 2-carboxylethyl ester, 11%, water 2%,
phenothiazon 0.2%, unknown components 0.8%.
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye was treated with one drop of physiological solution of sodium chloride and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: approx. 50 µL


Duration of treatment / exposure:
21 days
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Irritation parameter:
overall irritation score
Time point:
other: immediately after treatment
Score:
> 4
Reversibility:
not reversible
Remarks on result:
other: Observation of eyes revealed inmmediate corrosion after treatment
Irritant / corrosive response data:
One drop of indiluted Acrylic acid caused a severe corrosion of the conjunctiva and cornea as a result of an exposure period of 10 minutes. In the course of 8 to 14 days, a complete destruction of the eye was observed and the animal was sacrificed.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

The potential of Acrylic acid glacial to cause acute dermal irritation or corrosion was assessed in a test according to OECD TG 404 by single topical application of 0.5 mL of the test substance to the intact skin of 5 White New Zealand rabbits for 3 minutes under semi-occlusive dressing (BASF AG, 1998). In 2 animals brownish discolouration of the skin was observed. The observation period was terminated after the 1 hour - reading. The finding was assessed by macroscopic pathology indicating superficial necrosis and slight edema in one animal and discolouration of the application area in the other animal. Histopathological examination revealed epidermal coagulation necrosis with edematous swelling of the dermis (no full-thickness necrosis) in the first animal; severe swelling of collagen fibres in dermis and subcutis and pyknoses in the basal cell layer in the second animal.The skin findings of the remaining three animals (erythema, edema, scaling or eczematoid skin alteration) were not reversible within 14 days after removal of the patches. The brownish discolouration of the skin of 2/3 animals was assessed by macroscopic pathology after 14 days (study termination) indicating skin lesion in the application area. Histopathological examination revealed focal deep necrosis (full thickness necrosis), loss of the epidermal adnexa in necrosis area, perifocal moderate epithelial hyperplasia and diffuse inflammatory reaction (corium to subcutis) in the application area. Under the test conditions chosen and considering the described findings Acrylic acid glacial gives indication of causing full thickness destruction of skin tissue as a result of an exposure period of 3 minutes, when the observation period is extended to 14 days, but not within an observation period of 1 hour.

The potential of undiluted acrylic acid and its aqueous solutions at concentrations of 50, 20 and 10% to cause acute dermal irritation or corrosion was assessed by a single application to the sensitive skin of Vienna White rabbits for 1, 5 and 15 minutes (BASF AG, 1958). In this supporting study, undiluted acrylic acid gave indication of causing full thickness destruction of skin tissue with scar formation as a result of an exposure period of 1 minute. Application of a 50 % aqueous acrylic acid solution for 5 and 15 minutes caused degeneration of skin tissue, characterized by erythema, strong oedema, anaemic necrosis and scar formation at test termination. After exposure to a 20 % solution of acrylic acid for 5 and 15 min, respectively, slight erythema and at the end of the observation period scaling were observed. After 1 min exposure to the 20 % solution, skin findings (slight erythema) were fully reversible within 11 days. The application of a 10 % aqueous solution of AA to rabbit skin for 1, 5 and 15 minutes resulted in slight erythema that was completely reversible within 72 hours. In a further study the undiluted compound caused necrosis in 5 rabbits after 24 h exposure (Smyth, 1962). Repeated application of 10% and 5% acrylic acid in acetone (v/v) was irritating to the mouse skin; 1% acrylic acid in acetone (v/v) was non-irritating to the skin of mice and did not result in death or loss of body weight (DePass, 1984). In a study performed by Majka et al (1974) the undiluted test substance led to localised necrotic changes of the skin of rabbits that disappeared by leaving a scar after 45 days. Solutions of acrylic acid at concentrations of 0.6 and 0.3% did not cause any effects. At concentrations of 1.25 and 5% hyperaemia of the skin and at 10% and higher, oedema and necrosis of the skin were observed.

Eye irritation:

Hoechst Celanese Corp. performed an acute eye irritation study with acrylic acid neutralized with potassium hydroxide (forming a neutral 60% aqueous solution of potassium acrylate) which followed a modified Draize protocol. 9 animals were instilled with 0.1 mL of the test solution; the eyes of 3 animals were flushed with 20 mL of luke-warm water 2 seconds after instillation, the eyes of 3 animals were flushed with the same amount of water 4 seconds after instillation and 3 eyes were left unwashed. In addition, 1 animal was administered the same volume of test solution and the eye was flushed with 20 mL of luke-warm water 20 seconds later. Also, 1 animal was treated with 0.1 mL of the test solution and its eye flushed 4 seconds after instillation for a period of 1 minute. In those eyes that were unwashed, severe ocular damage resulted with corneal opacities occurring after 1 hour and persisting for the duration of the study (18 days). Those eyes that were flushed 2 and 4 seconds after instillation all developed opacities (3/3), (3/3) but cleared after 7 days. In the eye that was flushed with 20 mL of luke-warm water 20 seconds after instillation of 0.1 mL of the test substance, corneal opacity resulted which persisted for the full duration of the study. Finally, instillation of the same amount of test substance followed 4 seconds later by flushing with luke-warm water for a period of 1 minute, resulted in corneal opacity which lasted until study termination (Hoechst Celanese Corp., 1992).

In addition, there is an older BASF report available. Instillation of 50 µL of the undiluted test substance (86 % acrylic acid) into a rabbit eye led to severe corneal opacity (OECD Draize score 3). Within 8 days complete destruction of cornea, conjunctiva and nictitating membrane was observed and both animals were sacrificed (BASF AG 1958).

The presented data give indication that the serious damage to eyes caused by acrylic acid is not solely due to the acidic properties of this chemical since a neutralized 60 % aqueous solution of potassium acrylate caused irreversible corneal opacity in rabbit eyes unless they were washed within few seconds. Based upon all of the presented evidence, acrylic acid may cause severe damage to the eyes.

After application of the undiluted test substance acute inflammation, oedema of the lid and conjunctivae and hyperaemia, purulent secretion and opacity of the cornea were observed (Majka, 1974). In this study, inflammation disappeared after 20 days but permanent changes in the form of scars in the upper eyelid and a small area of opacity of the cornea were still observed. Similar but less severe findings were seen after instillation of a 10% acrylic acid solution. At 1 and 3% acute inflammation occurred that disappeared after 2 or 6 days without leaving permanent changes. In a further study by Smyth et al., 1962, corneal injury was observed in 9 out of 10 rabbits after application of the test substance. Furthermore, it was reported that a 1% solution was the lowest concentration of acrylic acid that caused significant injury to the rabbit eye (UnionCarbide,1977).

Respiratory irritation:

In standard acute inhalation tests there was evidence that acrylic acid vapours were severely irritating to the eyes and respiratory tract of rats (BASF AG 1980, BAMM 1988). Silver et al. (1981) confirmed the respiratory irritancy of acrylic acid by measuring its effect on the respiratory frequency, tidal volume, minute ventilation, and rectal temperature as indices for irritancy. Based on the available data corrosion to the respiratory tract cannot be excluded.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for skin corrosion and eye corrosion are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is considered to be classified for skin corrosion Cat.1A and for eye damaging properties (H314, H318) under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521. Based on the available data, corrosion to the respiratory tract cannot be excluded. Therefore, the substance is classified for specific target organ toxicity after single exposure: STOT SE Cat. 3 (H335, Specific concentration limits ≥1% -<5%) under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521. The substance is harmonized classified according to Regulation (EC) No 1272/2008, Annex VI for skin corrosion Cat.1A (H314) and STOT SE Cat.3 (H335, Specific concentration limits ≥1% -<5%).