4,4'-isopropylidenebis[2-allylphenol]

Endpoint summary

Description of key information

1) Determination of the acute dermal irritation/corrosion of TK 11907.
2) Eye irritation: Waiving was done according to ANNEX VII colum2 of the REACH regulation: the available information regarding skin irritation indicates that the criteria for classification as corrosive for the skin is met.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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.

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

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

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

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

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

1)The 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.

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.

2) The eye irritation test was waived because of the results of the skin irritation/corrosion experiment.

2) Eye irritation: Waiving was done according to ANNEX VII colum2 of the REACH regulation: the available information regarding skin irritation indicates that the criteria for classification as corrosive for the skin is met.

Justification for selection of skin irritation / corrosion endpoint:
Only this study is available

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Based on the above stated assessment of the skin irritation potential of TK 11907, the substance does have to be classified as Skin Corr. Cat 1B according to 1272/2008/ EC Regulation.