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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 from experimental study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity of the given test chemical was performed in female rats

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

yes

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:

rat

Strain:

other: SPF Wistar,Hoe: WISKF (SPF 71)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 234-244g (average weight 238g)
- Fasting period before study: The rats were not given any food for 16 hours before administered, 2 hours after the dye was administered,
- Housing: the animals were kept in plastic cages on plane rakes
- Diet (e.g. ad libitum): The animals were fed as the Postural diet ALTROMIN 1324 of the company Altromin GmbH in Lage / Lippe, ad libitum
- Water (e.g. ad libitum): tap water. libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5000mg/kg bw

- Justification for choice of vehicle: Test material suspended in 25% sesame oil

DOSAGE PREPARATION (if unusual): Test material suspended in 25% sesame oil

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 female rat

Control animals:

not specified

Details on study design:

Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination were performed

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No animal died on administration of 5000 mg/kg body weight.

Clinical signs:

other: The animals showed normal behavior

Gross pathology:

not specified

Other findings:

After administration of the dye, a dark blue feces and blue urine staining were observed.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The LD50 value was considered to be >5000 mg/kg bw, when female rats were treated with the given test chemical orally via gavage.

Executive summary:

In an acute oral toxicity study, 10 female SPF Wistar rats strain Hoe: WISKF (SPF 71) weighing 234-244g (average weight 238g) rats were treated with the given test chemical at the dose concentration of 5000 mg/kg bw. The 25% suspension of test material was dissolved in sesame oil and was administered once via oral gavage route. The rats were not given any food for 16 hours before application. 2 hours after the dye was administered, the animals were fed again. The observation time after administration was 14 days. During this time, the animals were kept Weekly weighed, the animals received as feed the ALTROMIN stabilizer 1324 of the company

Altromin GmbH in Lage/Lippe and tap water. Food and water were offered ad libitum. Animals were observed for mortality and clinical signs changes for 14 days. The experimental animals were killed at the end of the follow-up period in anesthesia, dissected and examined macroscopically. No animal died on administration of 5000 mg/kg body weight. After the application, the animals showed normal behavior. The body weight gain at the follow-up was regular. After administration of the dye, a dark blue feces and blue urine staining were observed. Under the condition of the study, the LD50 value was considered to be >5000 mg/kg bw, when female rats were treated with the given test chemical orally via gavage.