Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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
Details on test material:
- Name of test material : phthalylsulfathiazole
- Molecular formula : C17H13N3O5S2
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
dose level of 2000 mg/kg body weight (dose volume 10ml/kg) to three female rats
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
Doses:
DOSE FORMULATION :
Dose preparation of the test article was done freshly, few minutes prior to dosing. Test substance CAS No. 85-73-4 was dissolved in distilled water to obtain final concentration of 200mg/ml
No. of animals per sex per dose:
Three female rats were used per step for each dose level.
Control animals:
yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: non toxic in wistar albino rats

Any other information on results incl. tables

The acute oral toxicity study of 85-73-4 was conducted in wistar albino rats. The study was conducted with the compliance of OECD Guideline-423 for testing of chemicals.

The healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization to standard laboratory condition and divided into test compound and vehicle control group each having three animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All the Wistar albino rats which were treated with the test compound 85-73-4 observed normal without any mortality and clinical signs of toxicity. Furthermore, No clinical signs and mortality were observed in vehicle control group.
Executive summary:

Finally, it is concluded that the test compound,following the guideline OECD-423 is non toxic to wistar albino rats. According toGlobally Harmonised Classification System for Chemical Substances,it comes under the Globally Harmonized Classification (GHC) Category-5 (>2000-5000) and LD50cutoff is 5000 mg/kg b.wt.

Parameters

Incidence of clinical signs observed after dosing

Mortality

Day 0

DAY

Min

Hour

30

1

2

4

6

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Total*

Mortality (total)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

0/3

 

Clinical Signs

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0         =   No clinical sign (Normal)

+         =   Clinical Sign