Phthalylsulfathiazole

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute 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

Administration / exposure

Type of coverage:

open

Vehicle:

water

Duration of exposure:

14 days

Doses:

2000 mg/kg b.wt.

No. of animals per sex per dose:

No. of animals per dose group : 10 (5male & 5 female)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Ten healthy wistar albino rats of both sex (ranging b.wt 200±20 gm) selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test compound CAS No. 85-73-4was applied dermally at the dose level of 2000 mg/kg b.wt to each animal. The treated animals were 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), 7^thand 14^th(post treatment). The necropsy was performed on all animals which was died during the study or were sacrificed at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

SUMMARY OF RESULTS

Mortality:There was no incidence of mortality recorded after administration of test compound 85-73-4 at the dose level of 2000 mg/kg b.wt.

Clinical signs:The test compound CAS No. 85-73-4did not elicit any clinical signs of toxicity during the entire observation period. No skin reaction was observed after 24^thhrs. of patch removal.

Body weight:The body weight of each animal recorded on day 0, 7^thand 14^thshowed normal increase in weight was recorded.

Conclusion:Result obtained from present investigation can be concluded that the test compound CAS No. 85-73-4is acutely non toxic at the tested dose level of 2000 mg/kg b.wt in Wistar albino rats when applied by dermal route.The acute dermal LD₅₀of test compound CAS No. 85-73-4found to be more than 2000mg/kg b.wt. (> 2000 mg/kg b.wt.).