N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

data is from experimental reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" Guidelines

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: FDA Guidelines

Principles of method if other than guideline:

A test for skin compatibility was performed to assess the dermal irritation potential of the test chemical

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide

EC Number:

267-636-0

EC Name:

N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide

Cas Number:

67905-17-3

Molecular formula:

C22H16N2O4

IUPAC Name:

N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide

Test material form:

solid

Details on test material:

- Name of test material : N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide
- Molecular formula): C22H16N2O4
- Molecular weight : 372.378 g/mol
- Smiles notation : O=C(Nc1ccc(Nc2c3c(c(O)cc2)C(=O)c2c(cccc2)C3=O)cc1)C
- InChl: 1S/C22H16N2O4/c1-12(25)23-13-6-8-14(9-7-13)24-17-10-11-18(26)20-19(17)21(27)15-4-2-3-5-16(15)22(20)28/h2-11,24,26H,1H3,(H,23,25)
- Substance type: Organic
- Physical state: Powder

Test animals

Species:

rabbit

Strain:

other: SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5-2.0 kg
- Housing:The animals were kept in individual cages
- Diet (e.g. ad libitum): compound feed ERKA 8300 of feed plants Robert Koch oHG / Hamm, ad libitum
- Water (e.g. ad libitum): water, ad libitum


IN-LIFE DATES: From: 5.9.1977 To: 8.9. 1977

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

intact and scarified skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

500 mg of the powdered dye

Duration of treatment / exposure:

24 hours

Observation period:

after removal of patch 24-hour value) and 48 and 72 hours after the start of the test.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: flank skin
- % coverage: 3 × 3 cm square area
- Type of wrap if used: adhesive strip

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : after removal of patch 24-hour value) and 48 and 72 hours after the start of the test.

SCORING SYSTEM:
- Method of calculation: Based on the findings, the irritation index was determined according to the method described under "1500.41 in Federal Register 38, No. 917, 27, 9, 173, PG 27019"

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The dye was tolerated without irritation by all rabbits (index = 0)

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, The test chemical can be assessed as not irritating to skin.

Executive summary:

A test for skin compatibility was performed to assess the dermal irritation potential of the test chemical. The test was performed according to the "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" and FDA Guidelines.

6 SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga) were used for the study. The flank skin of 6 rabbits was depilated with an electric hair trimmer on two adjacent spots on a 3 × 3 cm area respectively. Either one of the clipped skin spots was additionally scarified using a scrape cutter. On 2.5 * 2.5 cm coarse lids of surgical gauze, 500 mg of the powdered dye was applied and glued to the prepared skin areas by means of an adhesive strip. The patches were covered by an infectious, impermeable, 6-8 cm wide PVC foil and then wrapped in an elastic permanent bandage. The exposure time was 24 hours.The dermal reactions were observed and scored after removal of the patches (24 hours) and 48 and 72 hours after the start of the test.

The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, the test chemical can be assessed as not irritating to skin.