[[(2-ethylhexyl)oxy]methyl]oxirane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from October 1, 1984 to October 18, 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

well documented under GLP principle

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Principles of method if other than guideline:

An area of about 6 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 mL/application of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. The patches were covered with an occlusive membrane and held in place for 6 hours by an adhesive tape. The treatment was repeated for 5 consecutive days. The skin reactions were evaluated 24 hours after each application.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[[(2-ethylhexyl)oxy]methyl]oxirane

EC Number:

219-553-6

EC Name:

[[(2-ethylhexyl)oxy]methyl]oxirane

Cas Number:

2461-15-6

Molecular formula:

C11H22O2

IUPAC Name:

2-{[(2-ethylhexyl)oxy]methyl}oxirane

Test material form:

other: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animal Strain: New Zealand white rabbits (KFM-NZW)
Breeder: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
Acclimatization period: 5 days
Group Size and Husbandry: The test was performed on 3 male rabbits , checked for normal skin conditions, weighing between 2 to 3 kg (approx. 12 - 14 weeks old) . The animals were housed individually in metal cages, identified with individually numbered ear tags, kept at a constant room temperature of 20 ±3 °C, at a relative humidity of 30 - 70% and on a 12 hours light cycle per day.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral flank

Amount / concentration applied:

0.5 mL/application of test substance

Duration of treatment / exposure:

held in place for 6 hours, repeated for 5 consecutive days

Observation period:

the observation period was extended to 17 days.

Number of animals:

3 males

Details on study design:

An area of about 6 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 mL/application of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. The patches were covered with an occlusive membrane and held in place for 6 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The treatment was repeated for 5 consecutive days. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 24 hours after each application according to the OECD scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean value

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean value

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean value

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean value

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean value

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean value

Time point:

24/48/72 h

Score:

ca. 1.66

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

see Table 1 and Table 2

Other effects:

No abnormal body weight gain was observed during the treatment period.

Any other information on results incl. tables

Table 1 Erythema

Animal No./sex	28 M		29M		30M
	CF	TF	CF	TF	CF	TF
After 1 days	0	1	0	1	0	1
After 2 days	0	2	0	2	0	2
After 3 days	0	3	0	3	0	3
Mean 1-3 days	0	2	0	2	0	2
After 4 days	0	4	0	4	0	4
After 5 days	0	4	0	4	0	4
Mean 1-5 days	0	2.8	0	2.8	0	2.8
After 7 days	0	2	0	3	0	3
After 10 days	0	1	0	1	0	2
After 14 days	0	0	0	0	0	0
After 17 days	0	0	0	0	0	0

Table 2 Edema

Animal No./sex	28 M		29M		30M
	CF	TF	CF	TF	CF	TF
After 1 days	0	0	0	0	0	0
After 2 days	0	2	0	1	0	2
After 3 days	0	2	0	2	0	3
Mean 1-3 days	0	1.3	0	1	0	1.66
After 4 days	0	3	0	3	0	3
After 5 days	0	3	0	2	0	3
Mean 1-5 days	0	2	0	1.3	0	2.2
After 7 days	0	2	0	3	0	3
After 10 days	0	1	0	1	0	2
After 14 days	0	0	0	0	0	0
After 17 days	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Criteria used for interpretation of results: EU CLP

Conclusions:

It can be concluded that test substance possess a cumulative skin irritation potential in albino rabbits.

Executive summary:

A 5-day skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of test substance on the albino rabbit skin. Under the experimental conditions employed, test substance induced weak erythema reactions after 1 treatment and strong erythema and edema reactions after repeated application comparing with control treatment. The skin reactions were reversible until the end of the observation period on day 17. Therefore, test substance can be classified as category 2 of skin irritation in the rats according to CLP (Regulation EC No. 1272/2008).