3-ethyloxetane-3-methanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 April 1998 to 30th April 1998.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-ethyloxetane-3-methanol

EC Number:

221-254-0

EC Name:

3-ethyloxetane-3-methanol

Cas Number:

3047-32-3

Molecular formula:

C6H12O2

IUPAC Name:

(3-ethyloxetan-3-yl)methanol

Specific details on test material used for the study:

- Name of test material (as cited in study report): TMP oxetane
- Physical state: Colourless liquid.
- Analytical purity: No information provided.
- Purity test date: No information provided.
- Lot/batch No.: JNS 980121 F 1-3
- Expiration date of the lot/batch: No information provided.
- Storage condition of test material: Stored in a refrigerator at 2 - 8°C in the dark.

Test animals

Species:

rabbit

Strain:

other: SPF albino rabbits of the stock Mol:Russian.

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Møllegaard Breeding and Research Centre A/S. Ejby, DK-4623, Lille Skensved.
- Age at study initiation: No information provided.
- Weight at study initiation: 2.5 - 2.6kg
- Housing: The animals were housed individually in PPO/HIPS cages with a perforated floor and floor area of 2576cm2.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet "Altromin 2123" available ad libitum.
- Water (e.g. ad libitum): Free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.

IN-LIFE DATES: From: To: No information provided.

Test system

Type of coverage:

not specified

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL

Duration of treatment / exposure:

4 hours exposure.

Observation period:

Observation period was 72 hours, with readings made at 24, 48 and 72 hours after exposure.

Number of animals:

Three animals.

Details on study design:

TEST SITE
- Area of exposure: Four shaved areas (2.5cm x 2.5cm) on the backs of the rabbits. The test material was applied to 2 sites, one on the left posterior and one on the right posterior.
- Type of wrap if used: Test material was applied to gauze patches which were applied to the shaved areas and secured with 2.5cm wide adhesive tape and fixed with Scanpor tape (5cm wide). Nobifix (6cm width) was then loosely wound round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following the 4 hour exposure period, the treated skin was cleaned with lukewarm water.
- Time after start of exposure: 4 hours after start of exposure.

SCORING SYSTEM: Readings made according to numerical scale.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Only the scores from the 3 readings (24, 48, 72 hours) are included in the calculation of the individual values. 

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: Only the scores from the 3 readings (24, 48, 72 hours) are included in the calculation of the individual values. 

Irritant / corrosive response data:

Very slight erythema was observed in two animals 1 hour from termination of exposure. Apart from that, no erythema was observed in any of the animals at the other observations. No oedema was observed in any of the animals at any of the observations.

Other effects:

No information provided.

Any other information on results incl. tables

Individual scores and mean values:

Rabbit No./Weight (kg)	Site	Erythema-Eschar observed at hours				Individual mean values*	Oedema observed at hours				Individual mean values*
		1	24	48	72		1	24	48	72
1116/2.5	LP	0	0	0	0	0.0	0	0	0	0	0.0
	RP	0	0	0	0		0	0	0	0
2888/2.5	LP	1	0	0	0	0.0	0	0	0	0	0.0
	RP	1	0	0	0		0	0	0	0
2102/2.6	LP	1	0	0	0	0.0	0	0	0	0	0.0
	RP	1	0	0	0		0	0	0	0

LP: Left posterior test field

RP: Right posterior test field.

* Only the scores from the 3 readings (24, 48, 72 hours) are included in the calculation of the individual values. 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, TMP oxetane was not found to be irritating to skin and does not meet the criteria for classification for skin irritation.

Executive summary:

The primary skin irritant effect of TMP oxetane was investigated in accordance with OECD Guideline 404 and EEC Guideline B.4. Three rabbits were exposed to the test article at 2 skin sites on the back, under an occlusive dressing. After 4 hours of exposure, the patches and tape were removed and the skin washed to remove test article with lukewarm water. Skin was examined at 1, 24, 48 and 72 hours after termination of exposure. No skin reactions or only very slight skin reactions were observed in all three animals from 1 to 72 hours after the termination of exposure. Under the experimental conditions described in the report, the mean score for erythema was 0.0 and for oedema was 0.0. Under the conditions of this study, TMP oxetane was not found to be irritating to skin.