Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute 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 : 8 to 10 weeks
Sex : Male and female
Body weight range : 200±20g
Identification : By cage tag and corresponding colour body marking
Acclimatization : The healthy wistar albino rats selected for study acclimatized to standard laboratory condition for period of one week under close Veterinary supervision.
Randomization : After acclimation and veterinary examination randomly selected in groups of three females.
Randomization: After acclimation and Veterinary examination all the animals randomly divided into two groups and each group having five male and five female rats.
Nutritional conditions: Animals were fasted overnight prior to test and food was offered three hours after dosing.

Administration / exposure

Type of coverage:
open
Vehicle:
water
Remarks:
distilled water
Details on dermal exposure:
The test drug 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid applied dermally under impervious gauze at the dose level of 2000 mg/kg b.wt in Group-I, II respectively. The test compound held in contact for period of 24 hrs. After 24 hrs, test compound was removed and wash with luke warm water and observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals which was died during the study or were sacrificed at termination of the study.
Duration of exposure:
24hrs.
Doses:
2000 mg/kg bwt
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Details on study design:
The test substance was applied uniformly over an exposed area of skin. The test compound was held in contact with the skin with an impervious dressing secured in place with an adhesive tape. The animals were then housed individually in cages with a collar around the neck in order to avoid the ingestion of the test compound. After 24 hours, the dressing was removed and the site of application was cleaned with lukewarm water wiping the test compound.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
dissolved
Remarks on result:
other: non toxic in wistar albino rats
Mortality:
The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any mortality at the tested dose level of 2000 mg/kg b.wt in wistar albino rats throughout the period of observation.
Clinical signs:
The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not elicit any clinical signs of toxicity entire the observation period. No skin reaction was observed after 24th hrs. of patch removal.
Body weight:
The body weight of animals treated with test compound observed on days 7th 14th showed normal gain in body as compared to day 0 (pre-treatment)
Gross pathology:
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.

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 dermal route. The acute dermal LD50 of test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid observed to be more than 2000 mg/kg b.wt.
Executive summary:

Mortality:

The test compound, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid,did not produce any mortality at the tested dose level of 2000 mg/kg b.wt in Wistar albino rats throughout the period of observation.

 

Clinical signs:

The test compound, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid,did not elicit any clinical signs of toxicity entire the observation period. No skin reaction was observed after 24thhrs. of patch removal.

 

Body weight:

The body weight of animals treated with test compound observed on days 7th& 14thshowed normal gain in body as compared to day 0 (pre-treatment)