2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl phenyl carbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 January, 2000 to 3 February, 2000.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl phenyl carbonate

EC Number:

248-882-8

EC Name:

2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl phenyl carbonate

Cas Number:

28173-59-3

Molecular formula:

C23H17NO7

IUPAC Name:

2-[(1-amino-4-hydroxy-9,10-dioxo-9,10-dihydroanthracen-2-yl)oxy]ethyl phenyl carbonate

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: New Zealand White Rabbit, SPF.
- Age at study initiation: 16 weeks (male), 14 weeks (females).
- Weight at study initiation: 2.8-3.1 kg.
- Accommodation: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and hay sticks for gnawing.
- Identification: By unique cage number and corresponding ear number.
- Diet: ad libitum
- Water: Tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 35-54 %
- Air changes: 10-15 air changes per hour.
- Photoperiod: light cycle of 12 hours light and 12 hours dark.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Bi-distilled water.

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount: 0.5 g/animal

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: Left flank of the rabbit.
- % coverage: 6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was flushed with lukewarm tap water to clean the application site.
- Time after start of exposure:

SCORING SYSTEM (Grading of Skin Reactions):
ERYTHEMA AND ESCHAR FORMATION:
-No erythema: 0
-Very slight erythema: 1
-Well-defined erythema: 2
-Moderate to severe erythema: 3
-Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema) reading:4

OEDEMA FORMATION:
-No oedema: 0
-Very slight oedema (barely perceptible): 1
-Slight oedema (edges of area well-defined by definite raising): 2
-Moderate oedema (edges raised approximately 1 mm): 3
-Severe oedema (raised more than 1 mm and extending beyond the area of exposure: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00.
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 oedema. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

VIABILITY/MORTALITY AND CLINICAL SIGNS:
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

COLORATION:
Red staining to light red staining produced by the test article was observed on the treated skin of all animals during all examination periods.

BODY WEIGHTS:
The body weight of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 93504/A is considered to be "not irritating" to rabbit skin.

Executive summary:

The primary skin irritation potential of FAT 93504/A was determined according to the OECD Guideline 404 (Acute Dermal Irritation/Corrosion). The primary skin irritation was investigated by topical application of 0.5 g to 6 cm2 intact left flank of each of three, (1male and 2 females), young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points. The primary irritation score was 0.00 (max. 8.0). Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 oedema. The test article caused red staining or light red staining of the treated skin during all examination periods. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), the test article is considered to be "not irritating" to rabbit skin.