2-ethylhexyl hydrogen maleate

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:

1975

Report date:

1975

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Federal Register 38, No. 187, 27.09.1973

Version / remarks:

1973

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Refer to section 'Principles of method if other than guideline'

Principles of method if other than guideline:

Deviation from OECD guideline 404:
- Occlosive type of coverage instead of semi-occlosive.
- Exposure period of 24 h instead of 4 hours.
- Examination of signs of irritation after 24 h, 48 h, 72 h and 96 h instead of examination after 1 h, 24 h, 48 h and 72 h after patch removal.
- Test substance application on the intact and scarified skin. According to guideline, the substance is only given to the intact skin.
The named deviations from the OECD guideline 404 represents a tightening of the test conditions.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl hydrogen maleate

EC Number:

231-048-2

EC Name:

2-ethylhexyl hydrogen maleate

Cas Number:

7423-42-9

Molecular formula:

C12H20O4

IUPAC Name:

2-Ethylhexyl hydrogen maleate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

Himalayan

Remarks:

SPF-Albino-Himalayan rabbits

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: Singly caged
- Diet: ERKA 8300 (Robert Koch oHG/Hamm), ad libitum
- Water: Tap water, ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

other: sesame oil

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted, 10% and 1% solution of the test item

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: An area of 3 x 3 cm was shaved and 2.5 x 2.5 gauze pads were applied to the skin areas.
- Type of wrap if used: The gauze pads were adhered to the prepared skin with an adhesive tape. The gauze pads were covered with an inpermeable, 6-8 cm wide PVC film and then wrapped with an elastic permanent bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS: 24 h, 48 h 72 h and 96 h

SCORING SYSTEM:
- Method of calculation: OECD Draize scheme

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: undiluted test item, intact and abraded skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: undiluted test item, intact and abraded skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 10% test item concentration, intact skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: 10% test item concentration, intact skin

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.9

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 10% test item concentration, abraded skin

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 10% test item concentration, abraded skin

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: 1% test item concentration, intact skin

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: 1% test item concentration, intact skin

Results 9

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: 1% test item concentration, abraded skin

Results 10

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: 1% test item concentration, abraded skin

Any other information on results incl. tables

Table 1: Results of the individual animals (undiluted test item concentration)

Animal No.	Irritation parameter	Hours
		24	48	72	96
94	Erythema score Edema score	4 4	4 4	4 4	4 4
95	Erythema score Edema score	4 4	4 4	4 4	4 4
96	Erythema score Edema score	4 4	4 4	4 4	4 4
97	Erythema score Edema score	4 4	4 4	4 4	4 4
98	Erythema score Edema score	4 4	4 4	4 4	4 4
99	Erythema score Edema score	4 4	4 4	4 4	4 4

 

Table 2: Results of the individual animals (10% test item concentration)

Animal No.	Irritation parameter	Hours
		24	48	72
394	Erythema score Edema score	2 2	0 0	0 0
393	Erythema score Edema score	2 2	0 0	0 0
392	Erythema score Edema score	1 0	1 0	0 0
391	Erythema score Edema score	1 1	1 0	0 0
390	Erythema score Edema score	1 1	1 0	0 0
389	Erythema score Edema score	1 1	1 0	0 0

 

Table 3: Results of the individual animals (1% test item concentration) 

Animal No.	Irritation parameter	Hours
		24	48	72
394	Erythema score Edema score	0 0	0 0	0 0
393	Erythema score Edema score	1 0	0 0	0 0
392	Erythema score Edema score	0 0	0 0	0 0
391	Erythema score Edema score	0 0	0 0	0 0
390	Erythema score Edema score	0 0	0 0	0 0
389	Erythema score Edema score	0 0	0 0	0 0

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

Based on the results of this skin irritation test, the test substance is considered to be irritating to the skin.

Executive summary:

The skin irritation potential of the test substance was investigated in a study according to Federal Register 38, No. 187, 1973 and which is equivalent to OECD guideline 404. The undiluted test substance as well as a 10% and 1% test substance solution was applied to the intakt and scarified skin of six rabbits. The test was performed under occlusive conditions for an exposure period of 24 hours. The skin was scored for signs of irritation after 24 h, 48 h, 72 h and 96 h.

The undiluted test substance induced severe erythema and severe edema after 24 hours of treatment in all rabbits on the intact and scarified flank skin (mean erythema score 24/48/72h = 4; mean edema core 24/48/72h = 4). The results were not reversible within 96 hours.

The observed very mild to mild erythema and edema in the 10% test item solution were reversible within 72 hours. The very mild edema and erythema in the 1% test item solution were reversible within 48 hours.

Based on the results of this skin irritation test, the test substance is considered to be irritating to the skin.