Oligomerisation products of 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane with acrylic acid and lauric acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 11, 1992 to august 14, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This test was conducted in compliance with EEC Methods, and was performed to comply with GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC Method Directive 84/449/EEC (OJ No. L251, 19.9.84), Part B, Method B.4. Acute toxicity (skin irritation)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

test substance without reactive diluent

IUPAC Name:

test substance without reactive diluent

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Acrylated compound
- Physical state: liquid
- Lot/batch No.: 10426
- Expiration date of the lot/batch: 27 November 1992

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: 10 to 13 weeks
- Weight at study initiation: 2.5-3.5 kg
- Housing: Individually in metal cages with perforated floors.
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet.
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 -1900 hours) in each 24 hours period.

Test system

Type of coverage:

other: Each treatment site was covered with "Elastoplast" elastic adhesive dressing for a four hours period.

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

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.

Duration of treatment / exposure:

The experimental phase of the study was undertaken between 11 and 14 August 1992./Single dermal dose

Observation period:

Four hours

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: 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.
- Type of wrap if used: Elastoplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with acetone to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: Each treatment site was covered with "Elastoplast" elastic adhesive dressing for a four hours period.

SCORING SYSTEM: Erythema and eschar formation and Oedema formation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

No dermal response to treatment was observed in any animal throughout the observation period.

Any other information on results incl. tables

Rabbit #	E = ErythemaO = Oedema	Day1, 2, 3, 4
579	EO	0, 0, 0, 00, 0, 0, 0
580	EO	0, 0, 0, 00, 0, 0, 0
581	EO	0, 0, 0, 00, 0, 0, 0

Applicant's summary and conclusion

Conclusions:

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

Executive summary:

An in vivo skin irritation study was conducted in accordance with Method B.4, Part B, EU DIrective 84/449/EEC, under GLP conditions. Three New zealand white rabbits were exposed to a single semi-occlusive application of 0.5 mL EB 3608 to intact skin for four hours. No dermal response to treatment was observed in any animal up to 72 hours post exposure. Under the study conditions, the test substance was not irritating to rabbit skin (Liggett, 1992).