Dimethyl maleate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

no GLP, analytical purity not reported, only few information on animal environmental conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

no GLP, analytical purity not reported, only few information on animal environmental conditions.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl maleate

EC Number:

210-848-5

EC Name:

Dimethyl maleate

Cas Number:

624-48-6

Molecular formula:

C6H8O4

IUPAC Name:

dimethyl (Z)-but-2-enedioate

Details on test material:

- Name of test material (as cited in study report): Maleic acid dimethylester
- Physical state: liquid
- Analytical purity: not reported

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK.
- Housing: animals were housed in standard conventional single cages.
- Diet (e.g. ad libitum): Standard diet ( “Ssniff K4” Versuchstierdiäten GmbH, Soest/Westfalen) ad libitum.
- Water (e.g. ad libitum): ad libitum.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C.
- Humidity (%): 40-60%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated skin area served as control.

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

The day before the application of the test substance the flank skin of each animal was shaved with an electric hair clipper on both sides on an area of about 6x6 cm.
For the treatment of each animal, 0.5 mL of the undiluted test substance was applied to a gauze patch (2.5 x 2.5 cm²).
The patch was then placed on the flanks of the animal and secured with an elastic, air permeable adhesive bandage.
After 4 hours the bandages were removed, and the exposed skin was washed with water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No sign of irritation or corrosion was found on the application site right after the exposure, and during and at the end of observation time.

Any other information on results incl. tables

Table 1. The individual skin reactions are collected in the following table.

Animal number	1 hours		24 hours		48 hours		72 hours		7 days		14 days
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
7	0	0	0	0	0	0	0	0	0	0	0	0
8	0	0	0	0	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

Suberg (1985)

In a primary dermal irritation study, the skin irritation/corrosion potential of dimethyl maleate was tested according to OECD guideline 404 with acceptable restrictions (no GLP, analytical purity not reported, only few information on animal environmental conditions). The shaved flank of 3 male New Zealand White rabbits was exposed to 0.5 mL dimethyl maleate for 4 hours under semiocclusive conditions. The rabbits were observed up to 14 days. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48 and 72 hours after removal of the test substance. No sign of irritation or corrosion was found on the application site right after the exposure, and during and at the end of observation time. Based on the study results, the dimethyl maleate was assessed as not irritating according to EU classification criteria.