(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 Nov. - 18. Dec. 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

1998

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

GLP compliance:

yes

Remarks:

Landesanstalt für Pflanzenbau und Pflanzenschutz Rheinland Pfalz, Sep 2001

Test material

Test material information

Constituent 1

Reference substance name:

(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

EC Number:

256-032-2

EC Name:

(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

Cas Number:

42978-66-5

Molecular formula:

C15 H24 O6

IUPAC Name:

(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S.A., Vonnas, France
- Weight at study initiation: 3.80 - 4.63 kg
- Housing: individually in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiaet, about 130 g/animal per day
- Water: ad libitum, tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml, undiluted

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull
stretch (adhesive fleece), Beiersdorf AG, semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1:1).
- Time after start of exposure: after the 4 hours of exposure


SCORING SYSTEM: accodring to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: the first 24 hours before the reading

Results 2

Irritation parameter:

edema 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:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

Slight eryrthema (grade 1) was observed in two animals immediately and 1 hour after removal of the patch and persisted in one animal up to 24 hours. Moderate erythema (grade 2), noted in one animal immediately and 1 hour after removal of the patch, decreased to slight erythema after 24 hours.
No other cutaneous reactions were observed during the study.
The cutaneous reactions were reversible in one animal within 24 hours and in two animals within 48 hours after removal of the patch.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

under the conditions of the present in vivo study with rabbits the test item was considered to be non-irritating to the skin.

Executive summary:

In-vivo, a skin irritation test was performed with three New Zealand White rabbits, according to OECD guideline 404 and in compliance with GLP (reliability 1). At least 24 hours before substance administration the dorsolateral part of the trunk of the animals was clipped. The untreated skin sites of the animals served as control. A 4-hour semiocclusive exposure to ca. 0.5 ml of the undiluted test substance produced the following effects: slight eryrthema (grade 1) was observed in two animals immediately and 1 hour after removal of the patch and persisted in one animal up to 24 hours. Moderate erythema (grade 2), noted in one animal immediately and 1 hour after removal of the patch, decreased to slight erythema after 24 hours. No other cutaneous reactions were observed during the study. The cutaneous reactions were reversible in one animal within 24 hours and in two animals within 48 hours after removal of the patch.

Based on this study findings the test item was considered to be non iriitating to the skin of rabbits.