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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:
1993-07-20 to 1993-07-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 12th May 1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 2-ethoxyethyl methacrylate, MAEE

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.3 ± 0.1 kg
- Housing: individually in polystyrene cages
- Diet (e.g. ad libitum): pelleted diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left flank served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze patches were held in contact with the skin by means of adhesive hypoallergic aerated semi-occlusive dressing and restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (after removal of the patches, no residual test substance was observed)

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 d
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight to moderate cutaneous reactions (erythema grade 1 and 2) were observed for up to 72 h (2/3 animals) or 4 d (1/3 animals) after the removal of the dressing. From day 3 to 6, a dryness of the skin was observed at the treatment site in 1/3 animals. During the whole observation period, the animals were free of edema.
All effects were fully reversible within 4 or 5 days.
Other effects:
no other effects reported

Any other information on results incl. tables

 

Rabbit number

reaction

score after 1h/24h/48h/72h/4d/5d/6d/7d

1

erythema (max score 4)

0/1/1/1/0/-/-

edema (max score 4)

0/0/0/0/0/-/-

2

erythema (max score 4)

1/2/2/1/0/-/-

edema (max score 4)

0/0/0/0/0/-/-

3

erythema (max score 4)

1/2/2/2/1/0/0

edema (max score 4)

0/0/0/0S/0S/0S/0

- = no cutaneous examination performed; S = dryness of skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
ETMA is not irritating to rabbit skin
Executive summary:

In a primary dermal irritation study according to OECD guideline 404, adopted 12 May 1981, 3 male New Zealand white rabbits were dermally exposed to 0.5 mL of ETMA (99.94 % a.i.) for 4 h to ca. 6 cm² body surface area. Animals then were observed for 6 days. Irritation was scored by the method of Draize.

Very slight to moderate cutaneous reactions (erythema grade 1 and 2) were observed for up to 72 hours (2/3 animals) or 4 d (1/3 animals) after the removal of the dressing. From day 3 to 6, a dryness of the skin was observed at the treatment site in 1/3 animals. During the whole observation period, the animals were free of edema. All effects were fully reversible within 4 or 5 days.

In this study, ETMA is not a dermal irritant.