Glycerol, propoxylated, esters with acrylic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

16 June 2004

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol, propoxylated, esters with acrylic acid

EC Number:

500-114-5

EC Name:

Glycerol, propoxylated, esters with acrylic acid

Cas Number:

52408-84-1

Molecular formula:

(C3H6O)m(C3H6O)n(C3H6O)oC12H14O6

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], .alpha.,.alpha.',.alpha.''-1,2,3- propanetriyltris[.omega.-[(1-oxo-2-propenyl)oxy]]-

Test material form:

liquid

Specific details on test material used for the study:

Batch No.: GK0561/158
Date of production: June 08, 2004

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., 01540 Vonnas, France
- Strain / quality: New Zealand White Al 077 INRA (SPF)
- Age at study initiation: 8 - 9 months
- Weight at study initiation:3.71 kg - 4.02 kg
- Housing:The animais were housed in fully air-conditioned rooms, in which a central air-conditioning system, Stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum):Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%.
- Photoperiod (hrs dark / hrs light):12 h light (6.00 a.m. - 6.00 p.m.), 12h darkness (6.00 p.m. - 6.00 a.m.)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin sites of the same animal.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: The test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 mL of the undiluted liquid test substance.

Duration of treatment / exposure:

4h

Observation period:

1h, 24h, 48h, 72h, 7d and 14d

Number of animals:

starting with 1, increased to 3.

Details on study design:

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

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

SCORING SYSTEM: according to Draize:
Erythema and eschar formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Weil defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema: 4

Edemna formnation
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area weil defined by definite raising): 2
Moderate edema (raised approx. 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond area of exposure: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Moderate erythema (grade 2), observed in all animais immediately after removal of the patch, persisted in two animais up to 1 hour and decreased to slight (grade 1) in one animal after 1 hour. Slight erythema, noted in two animais after 24 hours, persisted in one animal up to the 48-hour reading and in the other animal up to the 72-hour reading. No other cutaneous reactions were observed during the study. The cutaneous reactions were reversible within 24 hours, 72 hours or 7 days in one animal each.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met