Registration Dossier

Administrative data

Description of key information

Butyl acrylate is irritating to skin, eyes, and respiratory system.

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:
other: Basic data given: scientifically acceptable study report
Principles of method if other than guideline:
BASF test
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals 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:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animals
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:
15 min exposure
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 h
Score:
3.9
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 h
Score:
2.9
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 h
Score:
3.9
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1st Trial
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 1st Trial
Irritant / corrosive response data:
Twenty four hours following the 1-, 5- and 15-minute applications strong erythema and edema were seen. The 20-hour exposure (trial 1) caused slight necrosis in addition to erythema and edema. Six and eight days after the applications, slight scaling was observed for the 1-, 5- and 15 -minute applications. The 20-hour application (trial 1) caused parchment like necrosis of the upper skin layer and scaling. The trial 2 of 20 h application resulted into similar responses as observed in trial 1.

                                            Skin Irritation Score, Rabbit 1/2, Erythema

Exposure time

24 h

48 h

72 h

Mean

1 min

4a/3a

4a/3a

1/0

3/2

5 min

4a/4a

4a/4a

2a/4

3.3/4

15 min

4a/4a

4/4a

3a/4

3.7/4

20 h (trial 1)

4a/3a

4b/4b

4b/4b

4/3.7

Skin Irritation Score, Rabbit 1/2, Edema

Exposure time

24 h

48 h

72 h

Mean

1 min

3a/3a

3a/3a

0/3

2/3

5 min

3a/3a

3/3a

2a/2

2.7/2.7

15 min

3a/3a

3/3a

3a/2

3/2.7

20 h (trial 1)

3/3

3/3

3/3

3/3

a- extending beyond the area of application

b- livid

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Adopted according to OECD SIDS (publicly available peer reviewed source). Original document not available.
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.5 mL of the undiluted test substance were instilled into the eyes of 5 rabbits. The eyes were not rinsed.
GLP compliance:
no
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): 0.5 mL undiluted
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
5
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
Remarks on result:
other: no injury on 1, moderate to severe injury on 4 eyes (2 with iritis)

0.5 mL quantities produced no injury on 1, moderate to severe injury on 4 eyes (2 with iritis).

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

Butyl acrylate was applied to the skin of rabbits with an occlusive covering for one minute, 5 minutes, 15 minutes and 20 hours. After 24 hours, moderate to strong erythema and edema were observed in all exposure groups. Mean erythema scores (24-48-72 hours) for the 15-min and 20-hour exposure were 3.9 and 3.9, respectively. Mean edema scores (24-48-72 hours) for the 15-min and 20-hour exposure were 2.9 and 3.0, respectively. The effects were not fully reversible within 8 days. Six and eight days after the applications, slight scaling was observed for the 1-, 5- and 15 -minute applications. The 20-hour application caused parchment like necrosis of the upper skin layer and scaling (BASF AG 1978).

In a study by Celanese Chem. Co (1972) irritating effects were observed, but reversibility of these effects was not investigated. In addition, three other studies are available, but two for them the reliability was unknown (klimisch 4) and one was disregarded as different substances were tested simultaneously.

Thus, butyl acrylate was assessed to be irritating to the skin.

Eye irritation:

0.5 mL undiluted butyl acrylate was instilled into the eyes of 5 rabbits (one eye per animal). Observed effects ranged from no injury in one rabbit to moderate effects in 2 rabbits and severe effects (iritis) in 2 rabbits (Union Carbide 1971).

In another eye irritation study in White Vienna rabbits conducted according to an internal study protocol, 50 µL of the undiluted substance were instilled into the eyes of 2 rabbits. The adjacent untreated eyes of the same animals served as control. The eyes were not washed out as recommended by the OECD TG 405. Eye reactions were read after 1 and 24 hours. The effects were completely reversible within 24 hours (BASF AG 1958). In addition, two other studies are available, but for both the reliability was unknown (klimisch 4).

Based on a weight of evidence approach, butyl acrylate was assessed to be irritating to the eyes of rabbits.

Respiratory irritation:

An acute inhalation study was conducted according to ASTM E961-84, to evaluate the potential for Butyl Acrylate vapour to produce depression of respiratory rate resulting from airway irritation when administered to mice by head-only inhalation exposure. Respiratory depression may result from upper airway sensory irritation and/or pulmonary irritation. The RD50, the concentration producing a 50 % depression of respiratory rate, the LOEL and the NOEL were estimated. Seven groups of eight male Swiss Webster Crl:CFW(SW)BR mice were exposed to target concentrations of 30 ppm, 100 ppm, 200 ppm, 350 ppm, 650 ppm and 900 ppm of Butyl Acrylate as a vapour atmosphere. Respiratory rate was depressed by 5 %, 9 %, 40 %, 54 % and 60 % for the 30 ppm, 100 ppm, 200 ppm, 350 ppm and 650 ppm groups, respectively. Under the conditions of this study, the RD50 of Butyl Acrylate was 340 ppm (= 1.78 mg/L), the LOEL for respiratory depression was 100 ppm (= 0.52 mg/L) and the NOEL for respiratory depression was 30 ppm (= 0.16 mg/L, BAMM 2003 see chapter 7.2.2).

In addition, there is evidence from acute and subchronic inhalation studies that butyl acrylate vapours were irritating to the respiratory tract of rats (BASF AG 1978, 1980).

Justification for classification or non-classification

CLP classification (Regulation (EC) No 1272/2008):

- Skin corrosion/irritation: Category 2

- Serious eye damage/eye irritation: Category 2

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