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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
GISAAA Gigiena i Sanitariya
Author:
Mezhdunarodnaya Kniga
Year:
1993
Bibliographic source:
(V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1- 1936- Volume(issue)/page/year: 58(12),9,1993
Reference Type:
review article or handbook
Title:
RTECS Number : TH8575000
Author:
RTECS database
Year:
2012
Bibliographic source:
RTECS (Registry of Toxic Effects of Chemical Substances);GISAAA Gigiena i Sanitariya. For English translation, see HYSAAV. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1- 1936- Volume(issue)/page/year: 58(12),9,1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Data is from RTECS
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: amorphous
Details on test material:
- Name of test material : phthalylsulfathiazole
- Molecular formula : C17H13N3O5S2
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
30 days
Frequency of treatment:
intermittent
Doses / concentrations
Remarks:
Doses / Concentrations:
12900 mg/kg/30D (intermittent)
Basis:
no data

Results and discussion

Results of examinations

Details on results:
Gastrointestinal - changes in structure or function of esophagus

Effect levels

Dose descriptor:
other: TDL0
Effect level:
12 900 other: mg/kg/30D (intermittent)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: not specified
Remarks on result:
other: not specified

Target system / organ toxicity

Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified

Applicant's summary and conclusion

Conclusions:
TDLo - Lowest published toxic dose for phthalylsulfathiazole in rats was reported as 12900 mg/kg/30D (intermittent)

Executive summary:

TDLo - Lowest published toxic dose for phthalylsulfathiazole in rats was reported as 12900 mg/kg/30D (intermittent)