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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles (no analytical purity, no details given)

Data source

Reference
Reference Type:
publication
Title:
Evaluation of Damage to DNA After in Vivo Exposure to Different Classes of Chemicals.
Author:
Cesarone CF et al.
Year:
1982
Bibliographic source:
Arch. Toxicol., Suppl. 5: 355-359

Materials and methods

Principles of method if other than guideline:
Male Swiss CD1 mice were treated in vivo with a dose of 100 mg/kg bw . Four hours after administration, nuclei were isolated from target tissues (liver and kidney) and lysed on a membrane filter. DNA was eluted using an alkaline buffer as a function of the molecular weight followed by a microfluorometric assay of DNA. Details of this method were described by Cesarone et al. (1979).

Cesarone et al. (1979). Anal. Biochem. 100: 188-197
GLP compliance:
no
Type of assay:
other: Alkaline Elution Technique coupled with a microfluorometric assay for DNA damage

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Nitroaniline
- Analytical purity: no data

Test animals

Species:
mouse
Strain:
other: Swiss CD1
Sex:
male
Details on test animals and environmental conditions:
no further data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
no data
Duration of treatment / exposure:
once
Frequency of treatment:
once
Post exposure period:
4 hrs
Doses / concentrations
Remarks:
Doses / Concentrations:
100 mg/kg bw
Basis:
other: actually administered
No. of animals per sex per dose:
no data
Control animals:
yes, concurrent vehicle
Positive control(s):
no data

Examinations

Tissues and cell types examined:
liver and kidneys

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
not applicable

Any other information on results incl. tables

The elution rate (K), expressed in mL-1, is the mean of eight experiments (24 for controls) ± SD and has been computed using the formula:

K = ln (DNA% retained on the filter) / eluted volume

Results:

Compound

Dose

K (E-03) ± SD

 

[mg/kg bw]

Liver

Kidney

solvent control

-

21 ± 9

22 ± 10

2-nitroaniline

100

36 ± 4

36 ± 5

Applicant's summary and conclusion