9,10-Anthracenedione, 1,4,5,8-tetrakis[(4-butylphenyl)amino]-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECd TG 404, EPA OPPTS 870.2500 and in accordance with the Principles of Good Laboratory Practice (GLP).

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

445-710-5

EC Name:

-

Cas Number:

108313-21-9

Molecular formula:

C54H60N4O2

IUPAC Name:

1,4,5,8-tetrakis[(4-butylphenyl)amino]-9,10-dihydroanthracene-9,10-dione

Test material form:

other: dark green crystalline solid

Details on test material:

- Name of test material (as cited in study report): 1,4,5,8-Tetra (4'-n-butylphenylamino) Anthraquinone (TBPAAQ)
- Substance type: dark green crystalline solid
- Physical state: solid
- Analytical purity: > 97% active ingredient
- Lot/batch No.: Lot #020801; TD No. 02-045
- Expiration date of the lot/batch: 31 March 2004
- Stability under test conditions: expected to be stable for the duration of testing
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Davidson's Mill Farms, South Brunswick, NJ
- Age at study initiation: young adults
- Housing: singly housed
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326 approximately 150 grams daily
- Water (e.g. ad libitum): Filtered tap water was supplied ad-libitum by automatic water dispensing system
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -22°C
- Humidity (%): 46-55%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

The test substance was moistened with distilled water to achieve a dry paste by preparing an 80% w/w mixture

Controls:

no

Amount / concentration applied:

Five-tenths of a gram of the active ingredient (0.64 g of the test mixture, after correcting for the percent of active ingredient present and dilution) was applied to one 6 cm2 intact dose site on each animal.

Duration of treatment / exposure:

4 hours

Observation period:

approximately 1,24,48 and 72 hours after patch removal

Number of animals:

3

Details on study design:

Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing an 80% w/w mixture. Five-tenths of a gram of the active ingredient (0.64 g of the test mixture, after correcting for the percent of active ingredient present and dilution) was applied to one 6 cm2 intact dose site on each animal and covered with a 1 inch x 1 inch, 4-ply gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3 inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages. After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites gently wiped with water and a clean towel to remove any residual test substance.
Individual dose sites were scored according to the Draize scoring system at approximately 1, 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Irritant / corrosive response data:

The mean erythema and edema scores for all the three rabbits tested across the 24, 48 and 72 hours timepoints were zero.

Other effects:

One hour after patch removal, very slight erythema was noted for all three treated sites and very slight edema was observed at one dose site. All animals were free of dermal irritation within 24 hours.

Any other information on results incl. tables

Individual animal erythema and edema scores

Animal no.	Sex	Hours after patch removal
		24	48	72
8626	Male	0/0	0/0	0/0
8627	Male	0/0	0/0	0/0
8628	Male	0/0	0/0	0/0
Total		0/0	0/0	0/0
Mean		0/0	0/0	0/0

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, 1,4,5,8-Tetra (4'-n-butylphenylamino) Anthraquinone (TBPAAQ), the mean erythema and edema scores for the 24, 48 and 72 hours post exposure timepoints for all the 3 rabbits tested were 0, hence no classification for skin irritation is necessary.

Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for TBPAAQ to produce irritation after a single topical application. Five-tenths of a gram of the active ingredient (approximately 0.64 grams of the test substance) was moistened with distilled water and applied to the skin of three healthy rabbits for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al.

One hour after patch removal, very slight erythema was noted for all three treated sites and very slight edema was observed at one dose site. All animals were free of dermal irritation within 24 hours. Under the conditions of the study, 1,4,5,8-Tetra (4'-n-butylphenylamino) Anthraquinone (TBPAAQ), the mean erythema and edema scores for the 24, 48 and 72 hours post exposure timepoints for all the 3 rabbits tested were 0, hence no classification for skin irritation is necessary.