2-methoxyethyl acetoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline-study (non-GLP)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxyethyl acetoacetate

EC Number:

245-043-8

EC Name:

2-methoxyethyl acetoacetate

Cas Number:

22502-03-0

Molecular formula:

C7H12O4

IUPAC Name:

2-methoxyethyl 3-oxobutanoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): P5098
- Physical state: liquid
- Stability under test conditions: stable at room temperature
- Storage condition of test material: tightly closed at room temperature away from sunlight

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hylyne Rabbits Ltd., Commercial Rabbits, 78 Warring ton Road, Statham UK
- Age at study initiation: at least 11 weeks
- Weight at study initiation: 2.97-3.20 kg
- Housing: individual housing
- Diet (e.g. ad libitum): Standard Rabbit Diet, B.P. Nutrition (UK) Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): Tap water
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-22°C
- Humidity (%): 40-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 14 hours artificial light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Portions of the test article (0.5 ml) were applied to 1 intact and 1 abraded site on each animal and covered with patches of gauze (25 mm x 25 mm).

Duration of treatment / exposure:

4 hours

Observation period:

24, 48 and 72 hours

Number of animals:

6 animals

Details on study design:

Application of test article:
Twenty four hours prior to treatment, the back of each animal was clipped free of hair using veterinary clippers (Model A2, Oster,
Milwaukee, Wisconsin). The left side of the clipped area on each animal was left intact. The right side was abraded using a clipper head to penetrate the horny layer of the epidermis, but without causing bleeding or damage to the underlying dermis. Portions of the test article (0.5 ml) were applied to 1 intact and 1 abraded site on each animal and covered with patches of gauze (25 mm x 25 mm). A small plug of cotton wool weighing approximately 1 g was placed over the top of the pads to achieve uniform pressure over the whole treated surface. The pads were held in place by a strip of adhesive impermeable plaster, (Sleek, Smith and Nephew Ltd., Welwyn Garden City, Herts).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Score 1 observed in one animal after 4 hours

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Score 1 observed in two animals after 4 hours

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.2

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

Two animals showed very slight erythema and one animal very slight oedema in both intact and abraded sites 4 hours after treatment. All skin reactions regressed and appeared normal at the 24 hour observation. A primary irritation index of 0.17 was obtained. The test article was classified as a mild skin irritant. P5098 did not produce a corrosive response.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was classified as non-irritant to skin.

Executive summary:

A study was carried out according to OECD Guideline 404 (skin irritation) on six NZW rabbits. The test was performed in 1980 as non-GLP-study. Six albino rabbits were treated semi-occlusive with 0.5 g test item applied on a 25 x 25 mm gauze covered with patches. Observation times were 24, 48 and 72 hours after removal of the patch. Slight erythema and oedema were observed in two out of six animals, resulting in a primary irritation index of 0.2. The substance was classified as non-irritant to skin.