2-Propenoic acid, 2-propylheptyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-01-11 to 2008-02-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to OECD TG No. 404 and in compliance with GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

April 24, 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-propylheptyl acrylate

EC Number:

604-669-5

Cas Number:

149021-58-9

Molecular formula:

C13 H24 O2

IUPAC Name:

2-propylheptyl acrylate

Test material form:

other: liquid

Details on test material:

- Name of test material: 2-Propylheptylacrylat rein
-Test substance number: 07/0846-1
- Analytical purity: 98.5 area-%
- Isomers composition: about 87 % 2 Propylheptylacrylate and 10 % 4-methyl-2-propylhexylacrylate
- Analytical report no.: 07L00384
- Lot/batch No.: B4112/13 - 03122007
- Expiration date of the lot/batch: 2008-12-03
- pH-value: Ca. 5.5 (undiluted test substance)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rabbits / New Zealand white A 1077 INRA (SPF) from Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: 7 – 8 months
- Weight at study initiation: 3.78 kg – 4.36 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2. The animals were housed in fully air-conditioned rooms.
- Diet: Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: tap water ad libitum

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted test substance

Duration of treatment / exposure:

Exposure for 4 h.

Observation period:

Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14.

Number of animals:

3 animals (2 male/1 female)

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, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG

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: 4h

SCORING SYSTEM:
According to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.9

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

3.3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

Mean scores over 24, 48 and 72 hours for each animal were 2.3, 3.3 and 3.0 for erythema and 0.3, 1.3 and 1.3 for edema (see table 1).

Any other information on results incl. tables

Table 1: Individual cutaneous examinations and mean values.

		Exposure period 4 h
	Animal	Erythema	Edema	Additional findings
0 h	1	2	0
	2	2	0
	3	2	0
1h	1	2	0	15
	2	2	1	15,16
	3	2	1	15,16
24 h	1	3	1	15,16
	2	4	2	15,16
	3	4	2	15,16
48 h	1	2	0	15
	2	3	1	15,16
	3	3	1	15,16
72 h	1	2	0	15
	2	3	1	15,16
	3	2	1	15,16
7 d	1	2	0	S, 15, 17
	2	2	0	S, 15, 17
	3	2	0	S, 15, 17
14 d	1	2	0	S, 15, 17
	2	2	0	S, 15, 17
	3	2	0	S, 15, 17
Mean 24 – 72 h	1	2.3	0.3
	2	3.3	1.3
	3	3.0	1.3
Mean		2.9	1.0
		15: erythema extending beyond the area of exposure
		16: edema extending beyond the area of exposure
		S: scaling 17: scaling extending beyond the area of exposure

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU