2-ethoxyphenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 29 july 2003 to 04 dec 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD TG 404 compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

temperature and humidity sometimes outsides of the target

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxyphenol

EC Number:

202-358-5

EC Name:

2-ethoxyphenol

Cas Number:

94-71-3

Molecular formula:

C8H10O2

IUPAC Name:

2-ethoxyphenol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France.
- Age at study initiation: on the day of treatment, the animals were 2 to 4 months old.
- Weight at study initiation: on the day of treatment, the animals had a mean body weight ± standard deviation of 3.1 ± 0.1 kg.
- Identification: individual metal ear tag.
- Housing: no data
- Diet (e.g. ad libitum): free access to 110 pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
• temperature: 18 ± 3°C
• relative humidity: 30 to 70%
• light/dark cycle: 12 h/12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.


IN-LIFE DATES: From: 29 july 2003 To: 03 aug 2003

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated skin served as control

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: flanks
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

SCORING SYSTEM: EU and OECD scoring scale, based on individual grading of erytheme/eschar formation and edema formation. Erythema and edema possible scores: from 0 to 4.

TREATMENT
Preparation and selection of the animals
The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined in order to check the absence of any signs of skin irritation.

Application of the test item
As possible irritant effects were anticipated, the test item was evaluated on a single animal in the first instance. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank.
Since the test item was not irritant on this first animal, it was then applied for 4 hours to two other animals.
Doses of 0.5 mL of the test item were placed on a dry gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals.
The test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
The untreated skin served as control.
After removal of the dressing, for the application of 3 minutes, any residual test item was wiped off by means of a dry cotton pad.
No residual test item was observed on removal of the dressing for the application of 4 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 hours (in one animal), no erythema on other animals

Remarks on result:

other: Mean per animal over a 24 to 72 hours period: 0; 0 and 0.66

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable, no sign of edema

Remarks on result:

other: Mean for each animal over a 24 to 72 hours period: 0

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Results:

 

Rabbit n°		1 hour	24 hours	48 hours	72 hours	Mean
25	Erythema	0	0	0	0	0
	Edema	0	0	0	0	0
928	Erythema	2	0	0	0	0
	Edema	0	0	0	0	0
929	Erythema	2	1	1	0	0.66
	Edema	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritating to the skin, and not classified according to EU GHS system (CLP 1272/2008).

Executive summary:

In a study (CIT 2003), the potential of the test item Guetol to induce skin irritation was evaluated in rabbits according to OECD 404 guideline.

A single dose of 0.5 mL of the undiluted test item was applied to the closely-clipped skin of one flank.

The test item was held in contact with the skin by means of a semi-occlusive dressing.

Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.

The mean values of the scores for erythema and oedema were calculated for each animal.

After a 4-hour exposure (three animals), a well-defined erythema was noted in 2/3 animals on day 1. A very slight erythema persisted in one of them up to day 3.

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.66 for erythema and 0.0, 0.0 and 0.0 for oedema.

Based on these results, the test item Guetol is very slightly irritant when applied topically to rabbits but not warranting classification according to EU GHS (CLP 1272/2008).