Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 Sep 1992 to 05 Sep 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate

EC Number:

276-696-7

EC Name:

Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate

Cas Number:

72490-01-8

Molecular formula:

C17 H19 N O4

IUPAC Name:

ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Hra:(NZW)SPF strain

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2694 - 3066 g
- Housing: animals were individually housed in screen-bottom stainless steel cages in temperature- and humidity-controlled quarters.
- Diet: measured amount of rabbit Diet
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 44 - 57
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

IN-LIFE DATES: From: 02 Sep 1992 To: 05 Sep 1992

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 animals/sex

Details on study design:

TEST SITE
- Area of exposure: On day before treatment, the back and/or flanks of each animal were clipped free of hair to obtain an unblemished skin site. The test material was applied to the intact skin on each animal's back.
- Coverage: approximate exposure area of 6.25 cm2
- Type of wrap if used: 2.5 cm X 2.5 cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap and secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: using tap water and disposable paper towels. The test material was removed from the test sites as thoroughly as possible irritating the skin.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- At 4, 24, 48 and 72 hours.
- Animals were weighed just before test material administration. Approximately 30 minutes after removal of the test material, the degree of erythema and oedema at each test site was read according to the Draize technique (recorded as the 4-hour score). The untreated skin of each animal was used for comparison.

SCORING SYSTEM:
- Method of calculation: method of Draize. See Table 1 in 'Any other information on materials and methods incl. tables'.

TERMINATION
- At termination the experimental phase, all animals were designated to be euthanised and discarded.

STATISTICAL ANALYSIS
- No statistical analyses were required by the protocol.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Application of the test substance to the skin of rabbits under 4-hour semi occluded conditions resulted in no dermal irritation. The average of the 4-, 24-, 48-, and 72-hour scores is 0.0 (considered to be non-irritating).

Any other information on results incl. tables

Table 2: Individual irritation scores

Scores observed after	4 hours	24 hours	48 hours	72 hours
Erythema	0, 0, 0, 0, 0, 0	0, 0, 0, 0, 0, 0	0, 0, 0, 0, 0, 0	0, 0, 0, 0, 0, 0
Oedema	0, 0, 0, 0, 0, 0	0, 0, 0, 0, 0, 0	0, 0, 0, 0, 0, 0	0, 0, 0, 0, 0, 0

 

Table 3 Mean value irritation scores

Animal	mean 24-72 hrs
	erythema	oedema
1	0	0
2	0	0
3	0	0
4	0	0
5	0	0
6	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this EPA 81-5 study, the test substance has been found not to be skin irritating to rabbits.

Executive summary:

The objective this study was to assess the primary dermal irritation potential of the test substance in vivo, according to the EPA OPP 81-5 test guideline following GLP principles. An amount of 0.5 g unchanged test material was applied under semi-occlusive conditions for 4 hours to the clipped backs of 3 male and 3 female albino rabbits (Hra: New-Zeeland White), covering a surface area of 6.25 cm2. After 4 hours the test item was removed using tap water. Scoring was performed at 4, 24, 48 and 72 hours and after 3 days of application following the Draize system.

No signs of irritation, either erythema or oedema reactions, were observed. The 24/48/72 mean averages for these parameters were 0 for all animals.

Under the conditions of this study, the test substance was considered not to be irritating to the skin of rabbits.