2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 December 1997 - 09 January 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine

EC Number:

601-101-8

Cas Number:

111497-86-0

Molecular formula:

Molecular formula not available for this UVCB.

IUPAC Name:

2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): CN386 (Amine synergist)- Physical state: Clear colourless liquid- Lot/batch No.: CK664- Storage condition of test material: Room temperature and humidity

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Ace Animals, Boyertown, PA, USA- Weight at study initiation: 2.2 - 2.6 kg- Housing: Individually in suspended wire cages- Diet (e.g. ad libitum): Purina Rabbit Chow (Diet no. 5321)- Acclimation period: At least 5 daysENVIRONMENTAL CONDITIONS- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 ml/rabbit

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE- Area of exposure: 2.5 x 2.5 cm- Type of wrap if used: PlasticREMOVAL OF TEST SUBSTANCE- Washing (if done): Gentle washing with distilled water at the end of the exposure period, before scoring for dermal reactions- Time after start of exposure: 4 hoursSCORING SYSTEM: Numerical Draize technique

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

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

Erythema scores, very slight to well defined at 1 hour following patch removal, ranged from absent to severe through Day 1 and cleared by Day 14.One animal had poor hair regrowth on Day 7, which cleared by Day 14. Edema scores generally ranged from absent to slight through Day 7 and cleared by Day 14, with the exception of a score 3 (moderate) in one animal at 24 hours.

Any other information on results incl. tables

Table 1: Bodyweights (BW)
Rabbit N°	1	2	3
Pretest BW (kg)	2.2	2.6	2.2
Terminal BW	2.5	2.5	2.6

Table 2: Erythema and eschar formation
Rabbit N°	1	2	3	Mean
Time after patch removal				Score
1 h	1	1	2
24 h	1	2	4	2.33
48 h	2	2	4
72 h	0	2	4	2.00
7 d	0	2	4
14 d	0	0	0
Table 3: Edema
Rabbit N°	1	2	3	Mean
Time after patch removal				Score
1 h	0	0	2
24 h	0	3	2	1.67
48 h	0	2	2
72 h	0	2	2	1.33
7 d	0	1	2
14 d	0	0	0
Sum of mean scores				7.33
PDII				3.67
Table 4: Systemic observations
Rabbit N°	1	2	3
Time after patch removal
1 h	A	A	A
24 h	A	A	A
48 h	A	A	A
72 h	A	A	A
7 d	A	A	A
14 d	A	D	A
A: normal; D: diarrhea

Applicant's summary and conclusion

Conclusions:

Under the test conditions, the test substance was considered to be irritating but not corrosive to skin.

Executive summary:

A study was performed to assess the skin irritation potential of the test substance to the skin of New Zealand White rabbits according to OECD Guideline 404.

0.5 mL of test substance was applied to the clipped skin area on the back of each animal under a 25 x 25 mm gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 1, 24, 48 and 72 hours then 7 and 14 days.

The general health of the animals was monitored at each observation point (24, 48, 72 h, and 7 and 14 days). Bodyweights were recorded pre-test and at termination. Scoring was done according to the Draize methodology.

Erythema scores, very slight to well defined at 1 hour following patch removal, ranged from absent to severe through Day 1 and cleared by Day 14. One animal had poor hair regrowth on Day 7, which cleared by Day 14. Edema scores generally ranged from absent to slight through Day 7 and cleared by Day 14, with the exception of a score 3 (moderate) in one animal at 24 hours. The primary dermal skin irritation index was equivalent to 3.67.

Under the test conditions, the test substance was considered to be irritating but not corrosive to skin.