Registration Dossier

Administrative data

Endpoint:
nephrotoxicity
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented publication

Data source

Reference
Reference Type:
publication
Title:
In vitro nephrotoxicity induced by chloronitrobenzenes in renal cortical slices from Fischer 344 rats
Author:
Hong, S.K. et al.
Year:
2002
Bibliographic source:
Toxicology Letters 129: 133-141

Materials and methods

Principles of method if other than guideline:
Determination of gluconeogenesis capacity and lactate dehydrogenase release in renal cortical slices as measures of cellular function and cytotoxicity for the assessment of direct nephrotoxic effects.
GLP compliance:
not specified
Type of method:
in vitro
Endpoint addressed:
not applicable

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,3-dichloronitrobenzene
- Analytical purity: no data
- Source: Aldrich Chemical Co. (Milwaukee, WI)

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Inc. (Scottdale, PA)
- Weight at study initiation: 200-250 g
- Housing: standard plastic animal cages
- Diet (e.g. ad libitum): Purina Rat Chow ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 40-55
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
other: not applicable, in vitro study

Results and discussion

Details on results:
2,3-Dichloronitrobenzene was effective at decreasing pyruvate-stimulated gluconeogenesis at bath concentrations of 0.5 mM or greater. A bath concentration of 1.0 mM or greater was required for 2,3-dichloronitrobenzene to increase LDH realease.

Applicant's summary and conclusion