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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[ethylenebis(oxymethylene)]bisoxirane
EC Number:
218-746-2
EC Name:
2,2'-[ethylenebis(oxymethylene)]bisoxirane
Cas Number:
2224-15-9
Molecular formula:
C8H14O4
IUPAC Name:
2,2'-[ethylenebis(oxymethylene)]bisoxirane
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at the start of treatment: 11 weeks
- Weight at the start of treatment: 2.11 - 2.16 kg
- Housing: 1 animal / cage, auto flush stainless steel cages (450W x 600D x 360H (mm))
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: during the quarantine-acclimation period, all animals were observed for clinical signs once daily for 8 days in the initial test and for 10 days in the confirmatory test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): measurement value: 19.1–22.1, permissible range: 18.0–24.0
- Humidity (%): measurement value: 44.8–52.1, permissible range: 30.0–70.0
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Because no corrosion or severe irritant effects were observerd in the initial test, the confirmatory test was conducted using 2 animals.

Applicant's summary and conclusion

Executive summary:

This study was conducted to evaluate the potential skin irritation/corrosion after a single dermal application of the test substance, 2,2’-[ethylenebis(oxymethylene)]bisoxirane, in three 11 -week-old male New Zealand rabbits.

0.5 mL of the undiluted test substance was applied and held in contact with the skin by a semi-occlusive dressing for 4 h. Because no corrosion or servere irritant effects were observed in the initial test, the confirmatory test was conducted using 2 animals. Observation of application sites for skin response were conducted at 1, 24, 48 and 72 h after patch removal and evaluated according to the Draize's method. In both the initial and confirmatory tests, skin irritation was observed at 72 h after application. Therefore, additional dermal observations were conducted until Day 7.

In both the initial and confirmatory tests, erythema was observed at the test substance sites from 1 h after patch removal. Erythema was no longer observed on Day 7. The primary skin irritation index (P.I.I.) of the test substance was 1.5.

In both the initial and confirmatory tests, the control sites of all animals did not reveal any evidence of adverse skin reactions such as erythema or edema during the observation period.

During the observation period, no abnormal clinical signs or body weight gain was observed in any animal.