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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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Methods applied similar to OECD404, slight deviations from guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24h exposure instead of 4 h, no recovery period
Qualifier:
according to
Guideline:
other: according to method: §1500.41 Federal register 38, No. 187, 27.09.1973, p 27019.
Deviations:
no
GLP compliance:
no
Remarks:
performed before GLP guidelines

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monoethylenglykoldimethylether
- Analytical purity: not stated
- physical state: clear colourless liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG own breed
- Weight at study initiation: 1,9-2,7 kg
- Age at study initiation: no data
- Diet: ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water ad libitum
- Acclimatization period: no data

ENVIRONMENTAL CONDITIONS
- Housing: single cages

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0,5 ml of pure substance was applied.
Duration of treatment / exposure:
24 hours
Observation period:
24 hours post application
48 hours post application
72 hours post application
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (Hansamed). The plaster was fixed to the prepared skinarea (ca. 18 cm2) and then covered with a occlusive polyethylene foil and further fixed with an elastic bandage.

SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h / 48 h / 72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
0.33
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
3.33
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
3.33
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h / 48 h / 72 h
Score:
0.72
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
0.33
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
1.67
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
mean
Time point:
other: 24 h / 48 h / 72 h
Score:
1.33
Max. score:
4
Other effects:
Treated skin areas were dry, rough, hardened, raised and greenish discolured. The greenish discolouration dissappeared after 48 hours. In this areas after 48 hours haematoma of the lower skin layers were observed.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
With reference the reported scores and the absence reversibility of the observed effects Ethylene glycol dimethyl ether has to be classified as irritant to the skin (R38 - irritant to skin; H315 - causes skin irritation) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

Ethylene glycol dimethyl ether was tested for its skin irritant properties in 6 Himalayan rabbits. The study was performed according to OECD Guideline 404. Deviations were the absence of the recovery period of 14 days and a prolonged exposure period (24 hours). These conditions make the study design more rigid compared to the regarding OECD Guideline. Effects skin (erythema grades up to 4 and edema scores up to 2) were observed in all animals 48 hour after application. These signs were not reversible within the 72 hours observation period.

With reference the reported scores and the absence reversibility of the observed effects Ethylene glycol dimethyl ether has to be classified as irritant to the skin (R38 - irritant to skin; H315 - causes skin irritation, skin irritant category 2) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).