Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Age : 7 to 9 weeks
Sex : Female, nulliparous and non pregnant. It has been observed that females are generally more sensitive than males to toxic effects
Body weight range : 200±20g
Identification : By cage tag and corresponding colour body marking
Acclimatization : 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: drinking water
Vehicle:
water
Remarks:
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

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: non toxic in wistar albino rats
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:
Pathology
1.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 study
The organ showing gross pathological change during necropsy subjected for histopathological study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
From the result obtained from present investigation it can be concluded that the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid is acutely non toxic upto the tested dose level of 2000 mg/kg b.wt in wistar albino rats when applied by oral route.
The acute oral LD50 of test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid found to be more than 2000 mg/kg b.wt.
Executive summary:

Body weights

All the animals treated with the substance, 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. 

 

MORTALITY

Wistar albino rats treated with the test substance 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.

 

NECROPSY FINDING

A.     EXTERNAL

         i.   Skin-Skin and hair coat was observed wet.

        ii.   All external orifices-Normal   

 B.  INTERNAL

I. Subcutaneous- No change was observed.

ii. Superficial and deep lymph nodes-No change in mesenteric lymph node.

 

ABDOMINAL CAVITY

i.          Opening and general examination-In the abdominal cavity all the organs were present in normal position.

ii.         Spleen-Normal upto highest tested dose level 2000 mg/kg b.wt.

iii.       Digestive system-No gross changes were observed in stomach and intestine upto highest tested dose level 2000 mg/kg b.wt.

iv.       Liver and biliary ducts-No gross pathological changes were observed

v.        Excretory system-No gross pathological changes were observed upto highest tested dose level 2000 mg/kg b.wt.

vi.       Adrenal-Observed normal.

vii.     Male/female genital organs –Showed normal colour, consistency and no inflammatory changes upto highest tested dose level 2000 mg/kg b.wt.

 

THORACIC CAVITY

i.                    Opening and general examination-Thoracic cavity was found to be normal without any fluid, mucous or blood etc.

ii.                  Lungs-observed normal.

iii.                 Heart-No changes were observed in color and consistency. Heart found normal upto highest tested dose level 2000 mg/kg b.wt.

iv.                Thyroid-Normal in shape, size and surface upto highest tested dose level 2000 mg/kg b.wt.

 

CRANIAL CAVITY- Brain-Normal in shape and size.