7-anilino-4-hydroxynaphthalene-2-sulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from study report

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Principles of method if other than guideline:

Acute oral toxicity study of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid CAS no 40306-75-0 in Wistar albino rats

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid

EC Number:

254-879-2

EC Name:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid

Cas Number:

40306-75-0

Molecular formula:

C8H10N2O5S

IUPAC Name:

3-acetamido-5-amino-4-hydroxybenzenesulfonic acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid- Molecular formula : C8H10N2O5S- Molecular weight : 246.24 g/mole

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Age : 7 to 9 weeksSex : Female, nulliparous and non pregnant. It has been observed that females are generally more sensitive than males to toxic effectsBody weight range : 200±20gIdentification :By cage tag and corresponding colour body markingAcclimatization : One week in experimental room after veterinary examination.Randomization : After acclimation and veterinary examination randomly selected in groups of three females.Nutritional conditions : Fasted overnight prior to treatment. Food was offered three hours after dosing.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

The toxicity of the 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid following oral administration was assessed. The test drug was given orally via oral cannula at the dose level 2000 mg/kg b.wt in Group-II & Group III respectively. Whereas, distilled water was given in same manner as test group(Group I). The rats were observed for incidence of mortality and signs of intoxication for 14 days after the administration of test article. The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment). Necropsy was carried out on all the animals which died during the study or surviving animals were sacrificed at the end of the study to observe any gross pathological changes.

Doses:

2000 mg/kg b.wt

No. of animals per sex per dose:

Three female rats were used per step for each dose level.

Control animals:

yes

Details on study design:

The test compound was administered by oral route by using of oral cannula at the dose volume of 10 ml/kg b.wt. The treated animals were closely observed for clinical signs of intoxication, first 4 hours and every 1 hrs interval for 24 hrs after dosing and thereafter twice a day for 14 days. All the rats were observed at least twice daily to observe any clinical signs or behavioral changes. The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment).

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No effect on survival, clinical sign, body weight, gross pathology

Mortality:

Wistar albino rats treated with the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any mortality throughout the period of observation.

Clinical signs:

The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not show any clinical signs of toxicity at the tested dose level of 2000 mg/kg b.wt throughout the period of observation.

Body weight:

All the animals treated with 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid at the dose level of 2000 mg/kg b.wt showed normal gain in body weight as compared to control group .

Gross pathology:

Pathology1.Necropsy Necropsy was carried out on all the animals that died during the study or surviving animals were sacrificed at the end of the study to observe any gross pathological changes.2.Histopathological studyThe organ showing gross pathological change during necropsy subjected for histopathological study.

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid considered to be more than 2000 mg/kg b.wt.

Executive summary:

In a acute oral toxicity study, Wistar female rats were treated with 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in the concentration of 2000 mg/kg bw orally by gavage in distilled water and observed for 14 days. No effect on survival, clinical sign and body weight of treated female rats at 2000 mg/kg bw. No gross pathological changes were observed in treated female rata at 2000 mg/kg bw. Therefore, LD50 was considered to be > 2000 mg/kg bw when Wistar female rats were treated with 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid orally by gavage.