4-hydroxybutyl acrylate

Skin irritation / corrosion

Administrative data

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive conditions; readings after 72 hrs missing, only two animals tested

Principles of method if other than guideline:

Occlusive conditions were used during exposure. Reading after 72 h is missing and only two animals were tested.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxybutyl acrylate

EC Number:

219-606-3

EC Name:

4-hydroxybutyl acrylate

Cas Number:

2478-10-6

Molecular formula:

C7H12O3

IUPAC Name:

4-hydroxybutyl acrylate

Specific details on test material used for the study:

- Name of test material (as cited in study report): Butanediolmonoacrylate
- Chemical name: 2-Propenoic acid, 4-hydroxy ester
- Analytical purity: >= 94 %
- Substance No.: 77/759

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, 6050 Offenbach / Main, Germany
- Sex: male
- Age at study initiation: no data
- Mean body weight at study initiation: males 3.0 kg
- Diet (ad libitum): Ssniff K, standard diet for rabbits, INTERMAST GmbH, Soest, Germany
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
no details given

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

15 - 24 hrs before test start

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin areas of the same animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours or 5 min

Observation period:

8 days

Number of animals:

2 per timepoint

Details on study design:

4 h exposure:
TEST SITE
- Area of exposure: flank and back, 2 x 2 cm
- Type of wrap if used: the test patch which was wetted with the test substance was applied to the dorsal skin of the rabbits by means of a gummed linen patch that was fastened by an adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lutrol or lutrol:water (1:1)
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Draize Scoring System (1959)


5 min exposure:
TEST SITE
- Area of exposure: flank and back, 2.5 x 2.5 cm
- Type of wrap if used: the test patch which was wetted with the test substance was applied to the dorsal skin of the rabbits by means of a gummed linen patch that was fastened by an adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol or lutrol:water (1:1)
- Time after start of exposure: 5 min

SCORING SYSTEM: Draize Scoring System (1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(4h exposure)

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: findings extending far beyond the area of application

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(4h exposure)

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: findings (ery., ed.) extending beyond the area of application

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(4h exposure)

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: findings (ery., ed.) extending beyond the area of application

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(4h exposure)

Time point:

24/48 h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: findings (ery., ed.) extending beyond the area of application

Results 5

Irritation parameter:

erythema score

Basis:

animal: #1, #2

Remarks:

(5 min exposure)

Time point:

24/48 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal: #1, #2

Remarks:

(5 min exposure)

Time point:

24/48 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Application for 4 hours produced marked erythema (grade 3) and slight to very strong edema (grades 2-4) in 2/2 rabbits (observed at 4, 24 and 48 hours). After 8 days, slight erythema (grade 2) and slight edema (grade 2) still persisted in 2/2 and 1/2 rabbits, respectively. Scaling respectively severe scaling was observed in both animals. Corrosive effects in form of necrosis were not observed in any animal.
Both animals did not show a local irritation reaction upon 5 min exposure to the test substance.

Any other information on results incl. tables

Raw data for 4 h exposure:

Readings	Animal No.	Erythema	Edema	Additional findings
4 h	1	3	4	findings (ery., ed.) extending far beyond the area of application
	2	3	3	findings (ery., ed.) extending beyond the area of application
24 h	1	3	4	findings (ery., ed.) extending far beyond the area of application
	2	3	3	findings (ery., ed.) extending beyond the area of application
48 h	1	3	2	findings (ery., ed.) extending far beyond the area of application, severe desquamation
	2	3	2	findings (ery., ed.) extending beyond the area of application
8 d	1	2	0	scaling
	2	2	2	findings (ery., ed.) extending beyond the area of application, severe scaling

 

No effects were visible following a 5 min application.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria