Phthalylsulfathiazole

Acute Toxicity: oral

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

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Phthalylsulfathiazole

EC Number:

201-627-4

EC Name:

Phthalylsulfathiazole

Cas Number:

85-73-4

Molecular formula:

C17H13N3O5S2

IUPAC Name:

2-({4-[(1,3-thiazol-2-yl)sulfamoyl]phenyl}carbamoyl)benzoic acid

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 or test system 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