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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Federal Register 38, No. 187, 27.09.1973
Version / remarks:
1973
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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
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
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
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
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
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
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.