2-methylbutyl acrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Read-across of data for an analogous chemical. The target chemical and the source chemical are very closely related alkyl acrylate compounds. They differ only by the addition of a methyl group in the butyl portion of the molecule. Both molecules are expected to be metabolized via the same hydrolysis and enzymatic pathways. The data from the source chemical are experimental results from well documented study report which meet basic scientific principles and are considered to be acceptable with restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

BASF test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butyl acrylate

EC Number:

205-480-7

EC Name:

Butyl acrylate

Cas Number:

141-32-2

IUPAC Name:

butyl acrylate

Details on test material:

- Name of test material (as cited in study report): Butyl acrylate
- Analytical purity: 99 %

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system 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

Test system

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.

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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.

Any other information on results incl. tables

                                            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

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

The results presented in this summary are experimental results for the source chemical n-butyl acrylate. The results are considered to be appropriate for read-across to the target chemical 2-methylbutyl acrylate.