2-Propenoic acid, reaction products with dipentaerythritol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 18 Jan, 1994 to and 21 Jan, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, reaction products with dipentaerythritol

EC Number:

800-838-4

Cas Number:

1384855-91-7

Molecular formula:

Molecular formula not available for this UVCB.

IUPAC Name:

2-Propenoic acid, reaction products with dipentaerythritol

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): SR399
- Physical state: Viscous liquid
- Purity: Not known to HRC
- Lot/batch No.: HYH1309
- Expiration date of the lot/batch: January 1995
- Storage condition of test material: Room temperature in the dark
- Date received: 14 December 1993

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: Approx 17 to 19 weeks
- Weight at study initiation: 3.7 to 4.0 kg
- Housing: Individually in plastic cages with perforated floors in Building R 14 Room 1.
- Diet: SDS Stanrab (P) Rabbit Diet ( ad libitum)
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70%
- Air changes: 19 air changes/h
- Photoperiod: 12 h of artificial Iight (0700 - 1900 h) in each 24 h period

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

4 d

Number of animals:

3

Details on study design:

Approx 24 h prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approx 100 mm x 100 mm. A 0.5 mL amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact
skin site on each animal. Each treatment site was covered with "Elastoplast" elastic adhesive dressing for 4 h. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 3 d

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: No adverse effects were observed.

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 3 d

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: No adverse effects were observed.

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 3 d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: No adverse effects were observed.

Irritant / corrosive response data:

Very slight erythema was seen in all three animals on Days 1 and 2. The skin were normal on Day 3.

Any other information on results incl. tables

Dermal reactions observed after application of the test substance:

Rabbit number and sex	E=Erythema O=Oedema	Day
		1	2	3	4
2945 (male)	E O	1 0	1 0	0 0	0 0
2946 (male)	E O	1 0	1 0	0 0	0 0
2947 (male)	E O	1 0	1 0	0 0	0 0

Applicant's summary and conclusion

Interpretation of results:

other: EU CLP criteria not met

Conclusions:

Under the study conditions, the test substance was determined to be not irritating to the skin.

Executive summary:

A study was conducted to determine the skin irritation potential of test substance, DPHA to rabbit according to EU Method B.4, in compliance with GLP. Three rabbits were administered a single dermal dose of 0.5 mL under semi-occlusive dressing for 4 h. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water to remove residual test substance. The treated area was blotted dry with absorbent paper. All animals were observed daily for signs of toxicity and ill health. Examinations of treated skin were made on Day 1 (60 mins after removal of dressing), and on Days 2, 3 and 4 (i.e., 24, 48 and 72 h after exposure). Dermal irritation was assessed using the numerical grading system. Very slight erythema was seen in all three animals on Days 1 and 2. Skin was normal on Day 3. Under the study conditions, the test substance was determined not to be irritating to the skin (Parcell, 1994).