4,4'-isopropylidenebis[2-allylphenol]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Start of experiment: 14 January 1986 ; End of experiment 28 January 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP methodology followed and OECD guideline used to perfored the experiment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-isopropylidenebis[2-allylphenol]

EC Number:

217-121-1

EC Name:

4,4'-isopropylidenebis[2-allylphenol]

Cas Number:

1745-89-7

Molecular formula:

C21H24O2

IUPAC Name:

4-{1-[4-hydroxy-3-(prop-2-en-1-yl)phenyl]propyl}-2-(prop-2-en-1-yl)phenol

Test material form:

other: Viscous liquid.

Details on test material:

- Test substance: TK 11907
- Batch No.: Op. 1
- Generic name: XU 292 B
- Purity: Pilot-sample
- Physical properties: viscous liquid; insoluble in water
- Storage conditions: room temperature
- Validity: October 1991
- Safety precautions: gloves and face masks
- Test material received: November 19, 1985

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test System
- The albino rabbit is the recommended species for skin irritation/corrosion studies
- Animal Strain : New Zealand white rabbits (KFM-NZW)
- Breeder: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Acclimatization period: 5 days

Group Size and Husbandry:
The test was performed on 3 male rabbits, checked for normal skin conditions, weighing between 2300 to 2520 g (approx. 12-14 weeks old) . The animals were housed individually in metal cages, identified with individually numbered ear tags, kept at a constant room temperature of 20+3 °C, at a relative humidity of 30-70 % and on a 12 hours light cycle day.

The rabbits received ad libitum Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.

The body weight was recorded at start and on days 3, 7, and 14 of the test.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Both patches were moistened before application with distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80.

Controls:

other: A control gauze patch was applied to the contrelateral flank.

Amount / concentration applied:

0.5 grammes

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 males rabbits

Details on study design:

An area of at least 6 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (20 cm2 hearing
0.5 g of the test substance was applied to the flank. A control gauze patch was applied to the contralaterall flank. Both gauze patches were moistened before application with dstilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 (prepared by Pharmaceuticals Division, Ciba-Geigy L t d . ).

The patches were loosely covered with an aluminum foil (36 cm2 and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).


SCORING SYSTEM:

Erythema and eschar formation
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Total possible erythema score 4

Edema formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

male

Time point:

24/48/72 h

Score:

2.66

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

male

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

male

Time point:

24/48/72 h

Score:

2.66

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

male

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

male

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

male

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Irritant / corrosive response data:

TK 11907 induced maximal irritant effects which were not reversible within 14 days.
It has to be concluded that TK 11907 has corrosive effects in albino rabbits.

Any other information on results incl. tables

Body weight (g):

Animal N°	57	58	59
At start of test	2520	2300	2370
Day 3	2600	2310	2450
Day 7	2730	2400	2580
Day 14 (end of test)	2970	2580	2840

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions employed TK 11907 induced maximal skin irritation when applied to the clipped albino rabbit skin.
On account of the necrosis observed, full skin destruction is expected and, therefore, TK 11907 must be classified as corrosive.

Executive summary:

This acute skin irritation/corrosion study in albino rabbits (3 males) was performed to determine the irritant or corrosive potency of TK 11907 on the albino rabbit skin.

This test was based on the OECD guideline No. 404, adopted May 12, 1981, by the OECD council.

The test was performed under Good Laboratory Practice conditions and was subjected to periodical quality assurance evaluation.

Under the experimental conditions employed TK 11907 induced maximal skin irritation when applied to the clipped albino rabbit skin.

On account of the necrosis observed, full skin destruction is expected and, therefore, TK 11907 must be classified as corrosive.