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

Eye irritation

Administrative data

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

other: FDA Guidelines(Federal Register Vol. 38, No. 187, S 27019, 1973)

Principles of method if other than guideline:

The mucous membrane compatibility of the test chemical was assessed in rabbits

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 / tissue source

Species:

rabbit

Strain:

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

Details on test animals or tissues 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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg of the powdered dye

Duration of treatment / exposure:

single application

Observation period (in vivo):

The assessment was performed 1,7,24,48 and 72 hours after the treatment with the help of a magnifying glass.

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

6

Details on study design:

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

SCORING SYSTEM:The ocular lesions were observed and scored according to the classification given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p. 51, 1975".

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: The assessment was performed 1,7,24,48 and 72 hours after the treatment with the help of a magnifying glass. After collecting the 24-hour report, all eyes were spooled with physiological saline solution. After 48 hours and 72 hours, after instillation of a drop of fluorescein sodium in the dilution 1: 10000 = 0.001%.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 7 hours

Score:

16

Max. score:

110

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

After application of the powdered dye, the highest irritation index of 16 was determined after 7 hours. According to the classification listed in the annex, the dye is therefore slightly irritating to the mucosa.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

After application of the test chemical, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemicalwas therefore assessed to be slightly irritating to the eyes.

Executive summary:

A test for mucous membrane compatibility of the test chemical was performed in rabbits. 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. Single application of 100 mg of the powdered dye was instilled into the left conjunctival sac of 6 rabbits and the right eye remained untreated and served as control. The assessment for ocular lesions was performed 1, 7, 24, 48 and 72 hours after the treatment with the help of a magnifying glass. After collecting the 24-hour report, all eyes were spooled with physiological saline solution. After 48 hours and 72 hours, after instillation of a drop of fluorescein sodium in the dilution 1: 10000 = 0.001%. The ocular lesions were observed and scored according to the classification given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p. 51, 1975".

For the determination of the irritation index, the evaluations of the cornea (a), the iris (b) and the conjunctiva (c) are added for each rabbit at the respective reading time. The average value of the values ​​of all rabbits is calculated at the corresponding reading time. The highest index determined at one of the reading times is used for grading.

After application of the test chemical, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemicalwas therefore assessed to be slightly irritating to the eyes.