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
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), 7thand 14th(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 24thhrs. of patch removal.

Body weight:The body weight of each animal recorded on day 0, 7thand 14thshowed 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.).