N-(4-acetylaminophenyl)-3-hydroxynaphthalene-2-carboxamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study was carried out according to test guidline OECD401 and under GLP-conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(4-acetylaminophenyl)-3-hydroxynaphthalene-2-carboxamide

EC Number:

255-419-3

EC Name:

N-(4-acetylaminophenyl)-3-hydroxynaphthalene-2-carboxamide

Cas Number:

41506-62-1

Molecular formula:

C19H16N2O3

IUPAC Name:

N-(4-acetamidophenyl)-3-hydroxy-2-naphthamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Hoe WISKf (SPF 71)
- Source: Hoechst AG, Kastengrund, SPF breeding stock
- Weight at study initiation: male: 179 - 188g (average 185g); female: 174 - 182g (average 178g),
- Fasting period before study: 16 hours prior to administration and 4 hours after administraion
- Housing: macrolon cages/airconditioned rooms
- Diet: Altromin 1324, ad libitum
- Water. tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% potato starch in de-ionized water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % suspension

Doses:

2.000 mg/kg bw

No. of animals per sex per dose:

5 males/5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of body weighing: 1/week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Remarks on result:

other: no lethality of any of the 5 male and 5 female rats

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none detected

Clinical signs:

other: Squatting posture flanks pinched in Stilted, uncoordinated andataxic gait Irregular respiration All symptoms of poisoning reversible 3 days p. a.

Gross pathology:

no macroscopic effects (dissection of killed rats after post-observation period)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was >2.000 mg/kg bw after single oral gavage in male and female rats.
No classification for acute oral toxicity according to EC 1272/2008.

Executive summary:

Male and female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 2000 mg/kg bw (20 % suspension in potato starch (2%)/water mixture). No animal died during the 14 day observation period, resulting in a LD50 >2000 mg/kg bw.