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Administrative data

Description of key information

Skin: Rabbit, 15 min/20 h: Signs of redness and oedema were observed (BASF, 1962).

Eye: Rabbit, similar to OECD 405: Slight conjunctivitis (Draize grade 1), slight chemosis (grade 1) and slight corneal opacity (grade 1). Fully reversible within 48 hours (BASF, 1962).

Respiratory tract: Rat, 4h (vapour): Signs of respiratory tract irritation were observed (UCC, 1968, 1971)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal / lateral flank of the back. After the application time, the skin was washed with water which contained a mild detergent. The animals were observed 7 to 8 days and skin changes were recorded on working days. The report usually describes findings after 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 and 72 hours from the raw data have to be taken into account.
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material: Isobutylacrylat
- Physical state: liquid
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.68, 2.62, 2.66, 2.39 kg
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.2 mL/kg
- Concentration: undiluted


Duration of treatment / exposure:
1, 5, 15 min, and 20 hours
Observation period:
8 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol concentrated and Lutrol (50%)
- Time after start of exposure: 1 min, 5 min, 15 min respectively

SCORING SYSTEM:
Erythema formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet-redness) to slight, eschar formation (injuries in depth)

Edema formation:
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite rising)
3: Moderate edema (raised approx. 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond the area of exposure)

The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
15 min
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritant / corrosive response data:
Well defined erythema (Draize grade 2) and edema (grade 2) as well as skin petechiae were seen at 24 hours after exposure periods of 5 and 15 minutes, and 20 hours. Slight erythema (grade 1) and edema (grade 1) were seen at 24 hours after an exposure period of 1 minute. 8 days after exposure slight erythema (grade 1) and scaling was noted in animals of all exposure groups.

The test substance led to clearly visible skin irritation in both animals when treated for 1, 5, 15 min and 20 hours. To evaluate the skin irritation potential of the test substance, the scores of the 20 hour incubation have been used, but the scores for the 1 -15 min incubation have been also taken into account.

Readings

Animal

Exposure period: 1 min

Erythema

Edema

Additional findings

1 h

1

3

2

2

2

0

spotted appearance

24 h

1

2

2

spotted bleedings

2

2

0

spotted appearance

48 h

1

3

2

bleedings

2

2

0

72 h

1

2

0

2

0

0

7 d

1

1

0

desquamation

2

0

0

desquamation

Mean 24, 48, 72 h

1

2.66

1.33

2

2

0

Mean 24, 48, 72 h

1-2

2.33

0.665

Readings

Animal

Exposure period: 5 min

Erythema

Edema

Additional findings

1 h

1

3

2

2

2

0

24 h

1

3

3

spotted bleedings

2

3

0

48 h

1

3

2

bleedings

2

3

2

72 h

1

1

0

2

2

0

7 d

1

1

0

desquamation

2

0

0

desquamation

Mean 24, 48, 72 h

1

2.66

1.33

2

2

0

Mean 24, 48, 72 h

1-2

2.33

0.665

Readings

Animal

Exposure period: 15 min

Erythema

Edema

Additional findings

1 h

1

3

2

2

3

2

24 h

1

3

3

spotted bleedings

2

3

2

exceeding beyond area of exposure

48 h

1

3

2

bleedings

2

3

2

72 h

1

2

0

brown-red colouring

2

3

0

7 d

1

2

0

desquamation

2

0

0

desquamation

Mean 24, 48, 72 h

1

2.66

1.66

2

3

1.33

Mean 24, 48, 72 h

1-2

2.83

1.0

Readings

Animal

Exposure period: 20 hours

Erythema

Edema

Additional findings

24 h

1

3

3

2

3

0

spotted appearance

48 h

1

3

2

2

3

2

72 h

1

2

2*

2

2

2*

9 d

1

2

0

desquamation

2

0

0

desquamation

Mean 24, 48, 72 h

1

2.66

2.33

2

2.66

1.66

Mean 24, 48, 72 h

1-2

2.66

2.0

* The value was not given in the raw data, but at the 48-hours reading an edema was scored with 2 and at the 96-hour reading the same animal was also scored with an edema of 2, therefore it seems likely that the experimenters forgot to note the edema scoring at the 72-hours reading.  

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20.-23.08.1962
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:
Method: Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The non- or saline-treated adjacent eye served as control. The animals were observed several times on the day of treatment and up to 7 or 8 days afterwards. Findings were recorded on working days.
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material: Isobutyl acrylate, stabilized with 0.006% Hydrochinonmonomethylether
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.11 kg and 2.29 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent eye treated with NaCl
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 mL
- Concentration: undiluted
Duration of treatment / exposure:
not applicable because substance remained in the eye and was not washed out
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not rinsed

SCORING SYSTEM:
The original scoring system was converted into the OECD Draize score.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
1 and 24 hours after instillation of the test substance into the eyes, slight conjunctivitis (Draize grade 1), slight edema (grade 1) and slight corneal opacity (grade 1) were noted. These effects were all completely reversible within 8 days.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

The test item was applied undiluted to the skin of rabbits under occlusive conditions for one minute, 5 minutes, 15 minutes and 20 hours (BASF, 1962). After 24 hours, well-defined erythema and edema as well as skin petechiae were observed in all exposure groups. Mean erythema scores (24-48-72 hours) for the 15-min and 20-hour exposure were 2.83 and 2.66, respectively. Mean edema scores (24-48-72 hours) for the 15-min and 20-hour exposure were 1.0 and 2.0, respectively. The effects were not fully reversible within 7-9 days. Seven and nine days after the applications, desquamation was observed for the 1-, 5- and 15 -minute and 20-hour applications. The test item was assessed to be irritating to the skin.

Eye irritation:

In an eye irritation study in White Vienna rabbits (BASF, 1962) conducted according to an internal study protocol, 50 µL of the undiluted substance were instilled into the eye of 2 rabbits. The adjacent eyes of the same animals were treated with NaCl and served as control. The eyes were not washed out as recommended by the OECD TG 405. Eye reactions were read after 1, 24, 48 and 72 hours. Slight conjunctivitis (Draize grade 1), slight chemosis (grade 1) and slight corneal opacity (grade 1) were noted after 24 hours. The effects were completely reversible within 48 hours. Based on the mean scores observed for corneal opacity and conjunctival redness the test substance is judged as not irritant to the eyes of rabbits.

Respiratory irriation:

In acute inhalation toxicity studies vapour concentration of more than 1000 ppm (corresponding to approx. 5.2 mg/L) were irritating to skin, eyes, and respiratory tract (UCC, 1968, 1971)

Justification for classification or non-classification

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

The available data on skin and eye irritation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the available data, the substance is considered to be classified for skin irritation, Cat. 2, H315 and for specific target organ toxicity, single exposure (STOT SE), Cat. 3, H335 under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182. The substance is not considered to be classified for eye irritation under the same Regulation.